Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02527200
• Collaborator: (none)
• Enrollment: 56
• Locations: 32
• Arms: 2
• Actual Duration (Months): 60.4
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome.

Condition or Disease	Intervention/Treatment	Phase
Metabolism and Nutrition Disorder; Obesity	Drug: liraglutide; Drug: placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome.
• Actual Study Start Date: Nov 9, 2015
• Actual Primary Completion Date: Nov 4, 2020
• Actual Study Completion Date: Nov 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liraglutide	Drug: liraglutide; Injected s.c./ subcutaneously (under the skin) This trial consists of a part A and a part B. Part A of the trial is conducted in obese adolescents with PWS. Part B of the trial is conducted in obese children with PWS. Entry into part A and part B of the trial will be sequential.
Placebo Comparator: Placebo	Drug: placebo; Injected s.c./ subcutaneously (under the skin) This trial consists of a part A and a part B. Part A of the trial is conducted in obese adolescents with PWS. Part B of the trial is conducted in obese children with PWS. Entry into part A and part B of the trial will be sequential.

Outcome Measures

Primary Outcome Measures

1. Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks [Week 0, Week 16]

   Change in BMI SDS from baseline to week 16 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=[(y / M)^L - 1] / S*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial.

2. Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks [Week 0, Week 52]

   Change in BMI SDS from baseline to week 52 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=[(y / M)^L - 1] / S*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial.

Secondary Outcome Measures

1. Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 [At week 16]

   Percentage of participants achieving more than or equal to (≥) 5% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 5% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve ≥ 5% reduction in their baseline (week 0) BMI at week 16.

2. Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 [At week 52]

   Percentage of participants achieving more than or equal to (≥) 5% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 5% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve ≥ 5% reduction in their baseline (week 0) BMI at week 52.

3. Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 [At week 16]

   Percentage of participants achieving more than or equal to (≥) 10% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 10% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve ≥ 10% reduction in their baseline (week 0) BMI at week 16.

4. Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 [At week 52]

   Percentage of participants achieving more than or equal to (≥) 10% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 10% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve ≥ 10% reduction in their baseline (week 0) BMI at week 52.

5. Percentage of Participants With no Increase in BMI SDS at Week 16 [At week 16]

   Percentage of participants with no increase in BMI SDS at week 16 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 16 and 'No' infers percentage of participants with increase in BMI SDS at week 16.

6. Percentage of Participants With no Increase in BMI SDS at Week 52 [At week 52]

   Percentage of participants with no increase in BMI SDS at week 52 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 52 and 'No' infers percentage of participants with increase in BMI SDS at week 52.

7. Change in BMI From Baseline at Week 16 [Week 0, week 16]

   Change in body mass index (BMI) from baseline to week 16 is presented.

8. Change in BMI From Baseline at Week 52 [Week 0, week 52]

   Change in body mass index (BMI) from baseline to week 52 is presented.

9. Change in Body Weight (Kilogram (kg)) From Baseline at Week 16 [Week 0, week 16]

   Change in body weight (kg) from baseline to week 16 is presented.

10. Change in Body Weight (kg) From Baseline at Week 52 [Week 0, week 52]

    Change in body weight (kg) from baseline to week 52 is presented.

11. Change in Body Weight (Pounds (lb)) From Baseline at Week 16 [Week 0, week 16]

    Change in body weight (lb) from baseline to week 16 is presented.

12. Change in Body Weight (lb) From Baseline at Week 52 [Week 0, week 52]

    Change in body weight (lb) from baseline to week 52 is presented.

13. Change in Body Weight (Percentage [%]) From Baseline at Week 16 [Week 0, week 16]

    Change in body weight (%) from baseline to week 16 is presented.

14. Change in Body Weight (%) From Baseline at Week 52 [Week 0, week 52]

    Change in body weight (%) from baseline to week 52 is presented.

15. Change in Waist Circumference From Baseline at Week 16 [Week 0, week 16]

    Change in waist circumference from baseline to week 16 is presented.

16. Change in Waist Circumference From Baseline at Week 52 [Week 0, week 52]

    Change in waist circumference from baseline to week 52 is presented.

17. Change in Waist-to-hip Circumference Ratio From Baseline at Week 16 [Week 0, week 16]

    Change in waist-to-hip circumference ratio from baseline to week 16 is presented.

18. Change in Waist-to-hip Circumference Ratio From Baseline at Week 52 [Week 0, week 52]

    Change in waist-to-hip circumference ratio from baseline to week 52 is presented.

19. Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 [Week 0, week 16]

    Change in hyperphagia score (hyperphagia total score and hyperphagic behaviour, drive and severity score respectively), from baseline to week 16 is presented. The Hyperphagia Questionnaire (HQ)- Total Score. It contains 11 questions which are categorised into 3 subscales; Hyperphagic Behaviour, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. The HQ-Behaviour Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviours and a worse outcome. The HQ- Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome. The HQ- Severity Factor Score ranges from 2-10, with higher scores indicating higher severity.

20. Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 [Week 0, week 52]

    Change in hyperphagia score (hyperphagia total score and hyperphagic behaviour, drive and severity score respectively), from baseline to week 52 is presented.The Hyperphagia Questionnaire (HQ)- Total Score. It contains 11 questions which are categorised into 3 subscales; Hyperphagic Behaviour, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. The HQ-Behaviour Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviours and a worse outcome. The HQ- Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome. The HQ- Severity Factor Score ranges from 2-10, with higher scores indicating higher severity.

21. Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16 [Week 0, week 16]

    Change in hsCRP from baseline to week 16 is presented.

22. Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52 [Week 0, week 52]

    Change in hsCRP from baseline to week 52 is presented.

23. Change in Total Cholesterol From Baseline at Week 16 [Week 0, week 16]

    Change in Total cholesterol (measured as millimoles per liter (mmol/L) from baseline to week 16 is presented as ratio to baseline.

24. Change in Total Cholesterol From Baseline at Week 52 [Week 0, week 52]

    Change in total cholesterol (measured as millimoles per liter (mmol/L) from baseline to week 52 is presented as ratio to baseline.

25. Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16 [Week 0, week 16]

    Change in LDL-cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.

26. Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52 [Week 0, week 52]

    Change in LDL-cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.

27. Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16 [Week 0, week 16]

    Change in HDL-cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.

28. Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52 [Week 0, week 52]

    Change in HDL-cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.

29. Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16 [Week 0, week 16]

    Change in non-HDL cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.

30. Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52 [Week 0, week 52]

    Change in non-HDL cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.

31. Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16 [Week 0, week 16]

    Change in VLDL cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.

32. Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52 [Week 0, week 52]

    Change in VLDL cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.

33. Change in Triglycerides From Baseline at Week 16 [Week 0, week 16]

    Change in triglycerides (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.

34. Change in Triglycerides From Baseline at Week 52 [Week 0, week 52]

    Change in triglycerides (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.

35. Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16 [Week 0, week 16]

    Change in free fatty acids (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.

36. Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52 [Week 0, week 52]

    Change in free fatty acids (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.

37. Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 [Week 0, week 16]

    Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to week 16 is presented.

38. Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 [Week 0, week 52]

    Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to week 52 is presented.

39. Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16 [Week 0, week 16]

    Change in HbA1c from baseline to week 16 is presented.

40. Change in HbA1c From Baseline at Week 52 [Week 0, week 52]

    Change in HbA1c from baseline to week 52 is presented.

41. Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16 [Week 0, week 16]

    Change in FPG from baseline to week 16 is presented.

42. Change in FPG From Baseline at Week 52 [Week 0, week 52]

    Change in FPG from baseline to week 52 is presented.

43. Change in Fasting Insulin From Baseline at Week 16 [Week 0, week 16]

    Change in fasting insulin (measured as picomoles per litre (pmol/L)) from baseline to week 16 is presented as ratio to baseline.

44. Change in Fasting Insulin From Baseline at Week 52 [Week 0, week 52]

    Change in fasting insulin (measured as picomoles per litre (pmol/L)) from baseline to week 52 is presented as ratio to baseline.

45. Change in Fasting C Peptide From Baseline at Week 16 [Week 0, week 16]

    Change in fasting C peptide (measured as nano moles per liter (nmol/L)) from baseline to week 16 is presented as ratio to baseline.

46. Change in Fasting C Peptide From Baseline at Week 52 [Week 0, week 52]

    Change in fasting C peptide (measured as nano moles per liter (nmol/L)) from baseline to week 52 is presented as ratio to baseline.

47. Number of Participants in Glycaemic Category at Week 16 [week 16]

    Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 16 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG <5.6 mmol/L (<100 mg/dL) and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes: FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%.

48. Number of Participants in Glycaemic Category at Week 52 [Week 52]

    Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG <5.6 mmol/L (<100 mg/dL) and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes: FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%.

49. Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16 [Week 0, week 16]

    Change in HOMA-B from baseline to week 16 is presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5).

50. Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52 [Week 0, week 52]

    Change in HOMA-B from baseline to week 52 is presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5).

51. Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16 [Week 0, week 16]

    Change in HOMA-IR from baseline to week 16 is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5.

52. Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52 [Week 0, week 52]

    Change in HOMA-IR from baseline to week 52 is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5.

53. Number of Treatment Emergent Adverse Events [From week 0 to week 54]

    An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period included AEs are with an onset date on or after the first day of trial product administration and any of the following dates, whichever came first: a) 14 days after the last day on trial product, or b) Follow-up visit (week 54) for participants with trial product discontinuation, or c) Last study visit (participants withdrawn without follow-up visit (week 54)).

54. Number of Severe Treatment Emergent Episodes of Hypoglycaemia [From week 0 to week 54]

    Hypoglycaemic episode (blood glucose less than or equal to (<=) 3.9 mmol/L (70 mg/dL) Or greater than (>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Severe hypoglycaemia defined by American Diabetes Association (ADA) 2013 and International Society for Paediatric and Adolescent Diabetes (ISPAD) 2018: hypoglycaemic episode associated with severe cognitive impairment requiring external assistance for recovery. Endpoint was evaluated based on data from in-trial period which was defined as events with onset date on or after the first day of trial product administration and no later than the last study visit (week 54).

55. Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia [From week 0 to week 54]

    Symptomatic blood glucose confirmed hypoglycaemia: An episode that is blood glucose confirmed by plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Endpoint was evaluated based on data from in-trial period which was defined as events with onset date on or after the first day of trial product administration and no later than the last study visit (week 54).

56. Number of Participants With Occurrence of Anti-liraglutide Antibodies [From week 0 to week 54]

    Number of participants with occurrence of anti-liraglutide antibodies is presented. In the below table, 'Yes' infers number of participants with occurrence of anti- liraglutide antibodies and 'No' infers number of participants without anti- liraglutide antibodies.

57. Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 [Week 0, Week 16]

    A 12-lead ECG was performed at baseline (week 0) and week 16 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Number of participants in each ECG category at week 0 and weeks 16 are presented.

58. Number of Participants With Change in ECG From Baseline at Week 52 [Week 0, Week 52]

    A 12-lead ECG was performed at baseline (week 0) and week 52 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Number of participants in each ECG category at week 0 and week 52 are presented.

59. Change in Pulse From Baseline at Week 16 [Week 0, week 16]

    Change in pulse from baseline to week 16 is presented.

60. Change in Pulse From Baseline at Week 52 [Week 0, week 52]

    Change in pulse from baseline to week 52 is presented.

61. Change in Haematology: Haemoglobin From Baseline at Week 16 [Week 0, week 16]

    Change in haemoglobin from baseline to week 16 is presented.

62. Change in Haematology: Haemoglobin From Baseline at Week 52 [Week 0, week 52]

    Change in haemoglobin from baseline to week 52 is presented.

63. Change in Haematology: Haematocrit From Baseline at Week 16 [Week 0, week 16]

    Change in haematocrit from baseline to week 16 is presented.

64. Change in Haematology: Haematocrit From Baseline at Week 52 [Week 0, week 52]

    Change in haematocrit from baseline to week 52 is presented.

65. Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 [Week 0, week 16]

    Change in thrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes from baseline to week 16 is presented.

66. Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 [Week 0, week 52]

    Change in thrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes from baseline to week 52 is presented.

67. Change in Haematology: Erythrocytes From Baseline at Week 16 [Week 0, week 16]

    Change in erythrocytes from baseline to week 16 is presented.

68. Change in Haematology: Erythrocytes From Baseline at Week 52 [Week 0, week 52]

    Change in erythrocytes from baseline to week 52 is presented.

69. Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 [Week 0, week 16]

    Change in creatinine and bilirubin (total) from baseline to week 16 is presented.

70. Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 [Week 0, week 52]

    Change in creatinine and bilirubin (total) from baseline to week 52 is presented.

71. Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 [Week 0, week 16]

    Change in creatine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) from baseline to week 16 is presented.

72. Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 [Week 0, week 52]

    Change in creatine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) from baseline to week 52 is presented.

73. Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 [Week 0, week 16]

    Change in urea, sodium, potassium, calcium total and calcium albumin-corrected from baseline to week 16 is presented.

74. Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 [Week 0, week 52]

    Change in urea, sodium, potassium, calcium total and calcium albumin-corrected from baseline to week 52 is presented.

75. Change in Biochemistry: Albumin From Baseline at Week 16 [Week 0, week 16]

    Change in albumin from baseline to week 16 is presented.

76. Change in Biochemistry: Albumin From Baseline at Week 52 [Week 0, week 52]

    Change in albumin from baseline to week 52 is presented.

77. Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16 [Week 0, week 16]

    Change in CEA serum from baseline to week 16 is presented.

78. Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52 [Week 0, week 52]

    Change in CEA serum from baseline to week 52 is presented.

79. Change in Hormone Level: Calcitonin From Baseline at Week 16 [Week 0, week 16]

    Change in calcitonin from baseline to week 16 is presented.

80. Change in Hormone Level: Calcitonin From Baseline at Week 52 [Week 0, week 52]

    Change in calcitonin from baseline to week 52 is presented.

81. Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 [Week 0, week 16]

    Change in TSH and prolactin from baseline to week 16 is presented.

82. Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 [Week 0, week 52]

    Change in TSH and prolactin from baseline to week 52 is presented.

83. Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 [Week 0, week 16]

    Change in free T4 and ACTH from baseline to week 16 is presented.

84. Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 [Week 0, week 52]

    Change in free T4 and ACTH from baseline to week 52 is presented.

85. Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 [Week 0, week 16]

    Change in IGF-1 and cortisol from baseline to week 16 is presented.

86. Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 [Week 0, week 52]

    Change in IGF-1 and cortisol from baseline to week 52 is presented.

87. Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16 [Week 0, week 16]

    Change in DHEAS from baseline to week 16 is presented.

88. Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52 [Week 0, week 52]

    Change in DHEAS from baseline to week 52 is presented.

89. Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 [Week 0, week 16]

    Change in LH and FSH from baseline to week 16 is presented.

90. Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 [Week 0, week 52]

    Change in LH and FSH from baseline to week 52 is presented.

91. Change in Hormone Level: Estradiol (Females) From Baseline at Week 16 [Week 0, week 16]

    Change in estradiol (only for females) from baseline to week 16 is presented.

92. Change in Hormone Level: Estradiol (Females) From Baseline at Week 52 [Week 0, week 52]

    Change in estradiol (only for females) from baseline to week 52 is presented.

93. Change in Hormone Level: Testosterone (Males) From Baseline at Week 16 [Week 0, week 16]

    Change in testosterone (only for males) from baseline to week 16 is presented. The testosterone analysis for Part B could not be performed due to an unforeseen change in the assay used by the central laboratory to measure testosterone during the trial. This change in methodology prevented a direct comparison of values measured at different time points during the trial.

94. Change in Hormone Level: Testosterone (Males) From Baseline at Week 52 [Week 0, week 52]

    Change in testosterone (only for males) from baseline to week 52 is presented. The testosterone analysis for Part B could not be performed due to an unforeseen change in the assay used by the central laboratory to measure testosterone during the trial. This change in methodology prevented a direct comparison of values measured at different time points during the trial.

95. Number of Participants With Change in Pubertal Status From Baseline at Week 16 [Week 0, week 16]

    This outcome measure presents "pubertal status results" which is based on Tanner staging recorded at baseline (week 0), week 16. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Results are presented for the following categories: 1) For female: breast development and pubic hair development, 2) For male: penis development and pubic hair development. Each category shows number of participants in stages 1 to 5, where stage 1 represents "early pubertal development" and stage 5 represents "pubertal development equivalent to that of an adult".

96. Number of Participants With Change in Pubertal Status From Baseline at Week 52 [Week 0, week 52]

    This outcome measure presents "pubertal status results" which is based on Tanner staging recorded at baseline (week 0) and week 52. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Results are presented for the following categories: 1) For female: breast development and pubic hair development, 2) For male: penis development and pubic hair development. Each category shows number of participants in stages 1 to 5, where stage 1 represents "early pubertal development" and stage 5 represents "pubertal development equivalent to that of an adult".

97. Number of Participants With Change in Physical Examination From Baseline at Week 16 [Week 0, week 16]

    This outcome measure presents number of participants with physical examination findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" at baseline (week 0), week 16. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation.

98. Number of Participants With Change in Physical Examination From Baseline at Week 52 [Week 0, week 52]

    This outcome measure presents number of participants with physical examination findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" at baseline (week 0) and week 52. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation.

99. Height Velocity at Week 16 [Week 16]

    Height velocity was the change in height per year. The height velocity was calculated as the difference between current height and baseline divided by by time duration in days between those measurement time points and multiplied by 365 days. Height velocity calculated at Weeks 16 is presented.

100. Height Velocity at Week 52 [week 52]

     Height velocity was the change in height per year. The height velocity was calculated as the difference between current height and baseline divided by by time duration in days between those measurement time points and multiplied by 365 days. Height velocity calculated at Week 52 are presented.

101. Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16 [Week 0, week 16]

     C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidality, suicidal behaviour, suicidal ideation. Suicidality: emergence of any suicidal ideation or suicidal behaviour. Suicidal behaviour: when response is "yes" for any of the questions- actual attempt to suicide, engaged in non-suicidal self-injurious behaviour, interrupted attempt, aborted attempt, preparatory acts. Suicidal ideation: when response is "yes" for any of the questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. This outcome measure presents number of participants with "suicidal ideation or suicidal behaviour on C-SSRS" assessed at baseline (week 0), week 16. The questionnaire was not used in Part B due to the young age of the participants in Part B.

102. Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52 [Week 0, week 52]

     C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidality, suicidal behaviour, suicidal ideation. Suicidality: emergence of any suicidal ideation or suicidal behaviour. Suicidal behaviour: when response is "yes" for any of the questions- actual attempt to suicide, engaged in non-suicidal self-injurious behaviour, interrupted attempt, aborted attempt, preparatory acts. Suicidal ideation: when response is "yes" for any of the questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. This outcome measure presents number of participants with "suicidal ideation or suicidal behaviour on C-SSRS" assessed at baseline (week 0), week 52. The questionnaire was not used in Part B due to the young age of the participants in Part B.

103. Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 16 [Week 0, week 16]

     Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 16. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. The questionnaire was not used in Part B due to the young age of the participants in Part B.

104. Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 52 [Week 0, week 52]

     Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 52. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. The questionnaire was not used in Part B due to the young age of the participants in Part B.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial

• Confirmed diagnosis of PWS (Prader-Willi Syndrome) (by genetic testing)

• Male or female, age at the time of signing informed consent: - Part A: above or equal to 12 years and less than 18 years

• Tanner stage 2-5 pubertal development for part A, and Tanner stage 1 for part B

• BMI (body mass index) corresponding to equal or above 30 kg/m^2 for adults by international cut-off points1 and equal or above the 95th percentile for age and sex (for diagnosis of obesity)

• Stable body weight during the previous 90 days before screening ( below 10 kg self-reported weight change)

• Testing has been performed to evaluate for adrenal insufficiency and documented in medical record

Exclusion Criteria:

• Type 1 diabetes mellitus (T1DM)

• Type 2 diabetes mellitus (T2DM)

• Calcitonin equal or above 50 ng/L

• No change in treatment plan with growth hormone (GH) from randomisation to the end of the open-label period patients on growth hormone to stay on, patients off GH to stay off during this period. Adjustments in doses of growth hormone will be permitted)

• Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroids Carcinoma (MTC)

• History of pancreatitis (acute or chronic)

• Treatment with any medication prescribed for weight loss within 90 days before screening (e.g. orlistat, zonisamide, topiramate/phentermine, lorcaserin, phentermine, bupropion/naltrexone,liraglutide, metformin)

• Untreated adrenal insufficiency

• Suggestive history of, or significant risk of gastroparesis (e.g. marked abdominal bloating post meal, history of vomiting, severe constipation), as judged by the Investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Santa Monica	California	United States	90404
2	Novo Nordisk Investigational Site	Baltimore	Maryland	United States	21229
3	Novo Nordisk Investigational Site	Buffalo	New York	United States	14203
4	Novo Nordisk Investigational Site	Mineola	New York	United States	11501
5	Novo Nordisk Investigational Site	Columbus	Ohio	United States	43235
6	Novo Nordisk Investigational Site	Camperdown	New South Wales	Australia	2050
7	Novo Nordisk Investigational Site	Parkville	Victoria	Australia	3052
8	Novo Nordisk Investigational Site	Calgary	Alberta	Canada	T3B 6A8
9	Novo Nordisk Investigational Site	Montreal	Quebec	Canada	H4A 3J1
10	Novo Nordisk Investigational Site	ANGERS cedex 09		France	49033
11	Novo Nordisk Investigational Site	Bordeaux		France	33076
12	Novo Nordisk Investigational Site	Brest		France	29609
13	Novo Nordisk Investigational Site	BRON cedex		France	69677
14	Novo Nordisk Investigational Site	Haguenau		France	67504
15	Novo Nordisk Investigational Site	Lille		France	59037
16	Novo Nordisk Investigational Site	MARSEILLE Cédex 05		France	13385
17	Novo Nordisk Investigational Site	MONTPELLIER cedex 05		France	34295
18	Novo Nordisk Investigational Site	Nice		France	06200
19	Novo Nordisk Investigational Site	Paris		France	75012
20	Novo Nordisk Investigational Site	Paris		France	75015
21	Novo Nordisk Investigational Site	Rouen		France	76031
22	Novo Nordisk Investigational Site	Toulouse cedex 9		France	31059
23	Novo Nordisk Investigational Site	Fiumicino		Italy	00050
24	Novo Nordisk Investigational Site	Milano		Italy	20132
25	Novo Nordisk Investigational Site	Padova		Italy	35128
26	Novo Nordisk Investigational Site	Rotterdam		Netherlands	3015 CN
27	Novo Nordisk Investigational Site	Grafton		New Zealand	1023
28	Novo Nordisk Investigational Site	Ankara		Turkey	06010
29	Novo Nordisk Investigational Site	Istanbul		Turkey	34093
30	Novo Nordisk Investigational Site	Istanbul		Turkey	34890
31	Novo Nordisk Investigational Site	Samsun		Turkey	55139
32	Novo Nordisk Investigational Site	Trabzon		Turkey	61080

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Mar 25, 2021
• Statistical Analysis Plan - Dec 14, 2020

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02527200
• Other Study ID Numbers: NN8022-4179; 2014-004415-37; U1111-1162-7884; NL54145.078.15
• First Posted: Aug 18, 2015
• Last Update Posted: Feb 3, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prader-Willi Syndrome; Nutrition Disorders; Liraglutide

Study Results

Participant Flow

Recruitment Details

The trial was conducted at 20 sites in 8 countries as follows: Australia (2), Canada (1), France (7), Italy (2), Netherlands (1), New Zealand (1), Turkey (3), and the United States (3).

Pre-assignment Detail

Trial has part A & B, participants entered sequentially into part A & B, and were randomised 2:1 (liraglutide/placebo). Part A conducted in adolescents (≥12-<18 years [yrs], Tanner stage 2-5) with Prader-Willi Syndrome (PWS) and obesity; Part B in children (≥6-˂12 yrs, Tanner stage below 2 with PWS and obesity. On part A 16-week double-blind period completion, data monitoring committee reviewed PK data to un-blind part A safety data then recommended randomisation (liraglutide/placebo) in part B.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
Period Title: Overall Study
STARTED	20	12	17	7
Safety Analysis Set (SAS)	20	12	17	7
Full Analysis Set (FAS)	19	12	17	7
COMPLETED	17	9	15	7
NOT COMPLETED	3	3	2	0

Baseline Characteristics

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Total
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Total of all reporting groups
Overall Participants	19	12	17	7	55
Age, Customized (Count of Participants)
6 - <12 years	0 0%	0 0%	17 100%	7 100%	24 43.6%
12 - <18 years	19 100%	12 100%	0 0%	0 0%	31 56.4%
Sex: Female, Male (Count of Participants)
Female	10 52.6%	5 41.7%	11 64.7%	2 28.6%	28 50.9%
Male	9 47.4%	7 58.3%	6 35.3%	5 71.4%	27 49.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5.3%	0 0%	3 17.6%	1 14.3%	5 9.1%
Not Hispanic or Latino	18 94.7%	12 100%	11 64.7%	6 85.7%	47 85.5%
Unknown or Not Reported	0 0%	0 0%	3 17.6%	0 0%	3 5.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	1 5.9%	0 0%	1 1.8%
Black or African American	2 10.5%	0 0%	1 5.9%	0 0%	3 5.5%
White	11 57.9%	6 50%	10 58.8%	7 100%	34 61.8%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	6 31.6%	6 50%	5 29.4%	0 0%	17 30.9%

Outcome Measures

1. Primary Outcome

Title	Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks
Description	Change in BMI SDS from baseline to week 16 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=[(y / M)^L - 1] / S*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial.
Time Frame	Week 0, Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed" = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	12	16	7	34	19
Mean (Standard Deviation) [SDS score]	-0.18 (0.21)	-0.18 (0.23)	-0.50 (0.65)	-0.48 (0.39)	-0.33 (0.49)	-0.29 (0.32)

2. Primary Outcome

Title	Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks
Description	Change in BMI SDS from baseline to week 52 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=[(y / M)^L - 1] / S*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial.
Time Frame	Week 0, Week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	14	7	31	18
Mean (Standard Deviation) [SDS score]	-0.27 (0.37)	-0.13 (0.25)	-0.79 (1.21)	-0.71 (0.68)	-0.50 (0.88)	-0.36 (0.53)

3. Secondary Outcome

Title	Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16
Description	Percentage of participants achieving more than or equal to (≥) 5% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 5% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve ≥ 5% reduction in their baseline (week 0) BMI at week 16.
Time Frame	At week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	12	16	7	34	19
Yes	27.8 146.3%	8.3 69.2%	37.5 220.6%	57.1 815.7%	32.4 58.9%	26.3 NaN
No	72.2 380%	91.7 764.2%	62.5 367.6%	42.9 612.9%	67.6 122.9%	73.7 NaN

4. Secondary Outcome

Title	Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52
Description	Percentage of participants achieving more than or equal to (≥) 5% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 5% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve ≥ 5% reduction in their baseline (week 0) BMI at week 52.
Time Frame	At week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	14	7	31	18
Yes	29.4 154.7%	18.2 151.7%	35.7 210%	42.9 612.9%	32.3 58.7%	27.8 NaN
No	70.6 371.6%	81.8 681.7%	64.3 378.2%	57.1 815.7%	67.7 123.1%	72.2 NaN

5. Secondary Outcome

Title	Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16
Description	Percentage of participants achieving more than or equal to (≥) 10% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 10% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve ≥ 10% reduction in their baseline (week 0) BMI at week 16.
Time Frame	At week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	12	16	7	34	19
Yes	0 0%	0 0%	6.3 37.1%	14.3 204.3%	2.9 5.3%	5.3 NaN
No	100 526.3%	100 833.3%	93.8 551.8%	85.7 1224.3%	97.1 176.5%	94.7 NaN

6. Secondary Outcome

Title	Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52
Description	Percentage of participants achieving more than or equal to (≥) 10% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 10% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve ≥ 10% reduction in their baseline (week 0) BMI at week 52.
Time Frame	At week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	14	7	31	18
Yes	11.8 62.1%	0 0%	14.3 84.1%	28.6 408.6%	12.9 23.5%	11.1 NaN
No	88.2 464.2%	100 833.3%	85.7 504.1%	71.4 1020%	87.1 158.4%	88.9 NaN

7. Secondary Outcome

Title	Percentage of Participants With no Increase in BMI SDS at Week 16
Description	Percentage of participants with no increase in BMI SDS at week 16 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 16 and 'No' infers percentage of participants with increase in BMI SDS at week 16.
Time Frame	At week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	12	16	7	34	19
Yes	66.7 351.1%	75.0 625%	87.5 514.7%	100 1428.6%	76.5 139.1%	84.2 NaN
No	33.3 175.3%	25.0 208.3%	12.5 73.5%	0 0%	23.5 42.7%	15.8 NaN

8. Secondary Outcome

Title	Percentage of Participants With no Increase in BMI SDS at Week 52
Description	Percentage of participants with no increase in BMI SDS at week 52 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 52 and 'No' infers percentage of participants with increase in BMI SDS at week 52.
Time Frame	At week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	14	7	30	16
Yes	70.6 371.6%	72.7 605.8%	78.6 462.4%	100 1428.6%	73.3 133.3%	81.3 NaN
No	29.4 154.7%	27.3 227.5%	21.4 125.9%	0 0%	26.7 48.5%	18.8 NaN

9. Secondary Outcome

Title	Change in BMI From Baseline at Week 16
Description	Change in body mass index (BMI) from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	12	16	7	34	19
Mean (Standard Deviation) [kilogram per meter square (kg/m^2)]	-0.9 (1.4)	-0.8 (1.6)	-1.1 (1.5)	-1.5 (1.7)	-1.0 (1.4)	-1.1 (1.6)

10. Secondary Outcome

Title	Change in BMI From Baseline at Week 52
Description	Change in body mass index (BMI) from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	14	7	31	18
Mean (Standard Deviation) [kg/m^2]	0.8 (2.2)	-0.1 (2.1)	-0.6 (3.3)	-0.7 (2.7)	-0.7 (2.7)	-0.4 (2.3)

11. Secondary Outcome

Title	Change in Body Weight (Kilogram (kg)) From Baseline at Week 16
Description	Change in body weight (kg) from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	12	16	7	34	19
Mean (Standard Deviation) [(kilogram (kg))]	-1.7 (3.6)	-1.1 (5.0)	-0.6 (2.2)	-1.0 (2.7)	-1.2 (3.0)	-1.0 (4.2)

12. Secondary Outcome

Title	Change in Body Weight (kg) From Baseline at Week 52
Description	Change in body weight (kg) from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. (kilogram (kg))

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	14	7	31	18
Mean (Standard Deviation) [kilogram]	-0.4 (6.3)	1.9 (6.0)	3.0 (6.6)	2.8 (5.2)	1.1 (6.5)	2.3 (5.6)

13. Secondary Outcome

Title	Change in Body Weight (Pounds (lb)) From Baseline at Week 16
Description	Change in body weight (lb) from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	12	16	7	34	19
Mean (Standard Deviation) [pounds (lb)]	-3.7 (7.8)	-2.4 (11.0)	-1.4 (4.8)	-2.1 (5.9)	-2.6 (6.6)	-2.3 (9.2)

14. Secondary Outcome

Title	Change in Body Weight (lb) From Baseline at Week 52
Description	Change in body weight (lb) from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	14	7	31	18
Mean (Standard Deviation) [pounds]	-0.9 (13.9)	4.3 (13.2)	6.7 (14.4)	6.2 (11.5)	2.5 (14.4)	5.0 (12.3)

15. Secondary Outcome

Title	Change in Body Weight (Percentage [%]) From Baseline at Week 16
Description	Change in body weight (%) from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	12	16	7	34	19
Mean (Standard Deviation) [Percent change in body weight]	-1.7 (3.8)	-0.7 (3.7)	-1.1 (4.1)	-2.2 (5.5)	-1.4 (3.9)	-1.2 (4.3)

16. Secondary Outcome

Title	Change in Body Weight (%) From Baseline at Week 52
Description	Change in body weight (%) from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	14	7	31	18
Mean (Standard Deviation) [Percent change in body weight]	-0.4 (6.5)	2.3 (5.7)	6.3 (12.1)	4.9 (8.6)	2.6 (9.9)	3.3 (6.9)

17. Secondary Outcome

Title	Change in Waist Circumference From Baseline at Week 16
Description	Change in waist circumference from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	12	15	7	33	19
Mean (Standard Deviation) [centimeters (cm)]	-2.50 (4.52)	-2.44 (7.84)	-0.73 (6.14)	-1.04 (4.53)	-1.70 (5.31)	-1.92 (6.70)

18. Secondary Outcome

Title	Change in Waist Circumference From Baseline at Week 52
Description	Change in waist circumference from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	13	5	30	16
Mean (Standard Deviation) [centimeter]	-2.98 (8.68)	-3.48 (7.32)	0.45 (8.05)	0.97 (5.99)	-1.49 (8.45)	-2.09 (7.06)

19. Secondary Outcome

Title	Change in Waist-to-hip Circumference Ratio From Baseline at Week 16
Description	Change in waist-to-hip circumference ratio from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	12	15	7	33	19
Mean (Standard Deviation) [Waist-to-hip circumference ratio]	-0.01 (0.04)	-0.02 (0.06)	0.00 (0.06)	0.01 (0.04)	-0.01 (0.05)	-0.01 (0.05)

20. Secondary Outcome

Title	Change in Waist-to-hip Circumference Ratio From Baseline at Week 52
Description	Change in waist-to-hip circumference ratio from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	13	5	30	16
Mean (Standard Deviation) [waist-to-hip circumference ratio]	-0.01 (0.06)	-0.04 (0.06)	-0.02 (0.05)	-0.01 (0.07)	-0.02 (0.06)	-0.03 (0.06)

21. Secondary Outcome

Title	Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16
Description	Change in hyperphagia score (hyperphagia total score and hyperphagic behaviour, drive and severity score respectively), from baseline to week 16 is presented. The Hyperphagia Questionnaire (HQ)- Total Score. It contains 11 questions which are categorised into 3 subscales; Hyperphagic Behaviour, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. The HQ-Behaviour Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviours and a worse outcome. The HQ- Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome. The HQ- Severity Factor Score ranges from 2-10, with higher scores indicating higher severity.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	19	12	17	7	36	19
Hyperphagia behaviour score	-0.8 (2.01)	-1.7 (4.14)	-1.2 (3.83)	-2.6 (2.07)	-1.0 (2.97)	-2.0 (3.48)
Hyperphagia drive score	-0.9 (2.80)	-0.9 (2.61)	-1.8 (2.97)	-2.0 (2.89)	-1.3 (2.87)	-1.3 (2.69)
Hyperphagia severity score	-0.6 (1.54)	-0.3 (2.46)	-0.1 (1.65)	0.1 (1.46)	-0.4 (1.59)	-0.2 (2.12)
Hyperphagia total score	-2.4 (5.55)	-2.9 (5.79)	-3.1 (7.28)	-4.4 (5.65)	-2.7 (6.34)	-3.5 (5.63)

22. Secondary Outcome

Title	Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52
Description	Change in hyperphagia score (hyperphagia total score and hyperphagic behaviour, drive and severity score respectively), from baseline to week 52 is presented.The Hyperphagia Questionnaire (HQ)- Total Score. It contains 11 questions which are categorised into 3 subscales; Hyperphagic Behaviour, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. The HQ-Behaviour Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviours and a worse outcome. The HQ- Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome. The HQ- Severity Factor Score ranges from 2-10, with higher scores indicating higher severity.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	11	14	5	32	16
Hyperphagia behaviour score	-0.9 (3.20)	-0.6 (2.62)	-0.7 (4.63)	-2.6 (3.65)	-0.8 (3.82)	-1.3 (3.00)
Hyperphagia drive score	-2.2 (2.90)	-0.5 (2.42)	-1.1 (3.99)	-1.4 (4.45)	-1.7 (3.41)	-0.8 (3.06)
Hyperphagia severity score	-1.3 (1.81)	-0.9 (2.51)	-0.4 (2.73)	-1.4 (1.82)	-0.9 (2.27)	-1.1 (2.26)
Hyperphagia total score	-4.4 (6.57)	-2.1 (6.11)	-2.1 (10.11)	-5.4 (8.32)	-3.4 (8.23)	-3.1 (6.77)

23. Secondary Outcome

Title	Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16
Description	Change in hsCRP from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	12	11	6	28	18
Mean (Standard Deviation) [Milligram per liter (mg/L)]	0.79 (2.58)	-0.57 (6.61)	-2.79 (8.03)	1.87 (2.12)	-0.61 (5.57)	0.24 (5.57)

24. Secondary Outcome

Title	Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52
Description	Change in hsCRP from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	10	12	5	28	15
Mean (Standard Deviation) [mg/L]	0.25 (2.55)	0.14 (3.67)	-2.42 (9.19)	-0.37 (0.84)	-0.89 (6.31)	-0.03 (2.99)

25. Secondary Outcome

Title	Change in Total Cholesterol From Baseline at Week 16
Description	Change in Total cholesterol (measured as millimoles per liter (mmol/L) from baseline to week 16 is presented as ratio to baseline.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	12	12	5	29	17
Mean (Standard Deviation) [Ratio of total cholesterol]	0.99 (0.10)	1.06 (0.14)	1.02 (0.11)	0.97 (0.10)	1.00 (0.10)	1.03 (0.14)

26. Secondary Outcome

Title	Change in Total Cholesterol From Baseline at Week 52
Description	Change in total cholesterol (measured as millimoles per liter (mmol/L) from baseline to week 52 is presented as ratio to baseline.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	10	12	5	28	15
Mean (Standard Deviation) [Ratio of total cholesterol]	1.00 (0.18)	1.06 (0.15)	1.01 (0.12)	1.07 (0.07)	1.01 (0.15)	1.06 (0.13)

27. Secondary Outcome

Title	Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16
Description	Change in LDL-cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	12	5	29	16
Mean (Standard Deviation) [Ratio of LDL-cholesterol]	1.01 (0.15)	1.13 (0.19)	1.04 (0.17)	0.96 (0.14)	1.02 (0.16)	1.07 (0.19)

28. Secondary Outcome

Title	Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52
Description	Change in LDL-cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	10	12	5	28	15
Mean (Standard Deviation) [Ratio of LDL-cholesterol]	1.02 (0.22)	1.12 (0.23)	0.99 (0.19)	1.06 (0.10)	1.01 (0.20)	1.10 (0.19)

29. Secondary Outcome

Title	Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16
Description	Change in HDL-cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	12	5	29	16
Mean (Standard Deviation) [Ratio of HDL-cholesterol]	0.96 (0.14)	1.00 (0.20)	1.01 (0.14)	1.12 (0.13)	0.98 (0.14)	1.04 (0.19)

30. Secondary Outcome

Title	Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52
Description	Change in HDL-cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	10	12	5	28	15
Mean (Standard Deviation) [Ratio of HDL-cholesterol]	0.99 (0.19)	1.02 (0.17)	1.06 (0.16)	1.08 (0.12)	1.02 (0.18)	1.04 (0.15)

31. Secondary Outcome

Title	Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16
Description	Change in non-HDL cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	12	5	29	16
Mean (Standard Deviation) [Ratio of non-HDL cholesterol]	1.02 (0.16)	1.09 (0.15)	1.03 (0.16)	0.93 (0.12)	1.02 (0.15)	1.04 (0.16)

32. Secondary Outcome

Title	Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52
Description	Change in non-HDL cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	10	12	5	28	15
Mean (Standard Deviation) [Ratio of non-HDL cholesterol]	1.02 (0.22)	1.07 (0.19)	1.00 (0.16)	1.07 (0.13)	1.01 (0.19)	1.07 (0.17)

33. Secondary Outcome

Title	Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16
Description	Change in VLDL cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	12	12	5	29	17
Mean (Standard Deviation) [Ratio of VLDL cholesterol]	1.05 (0.36)	0.98 (0.27)	1.05 (0.46)	0.80 (0.17)	1.05 (0.40)	0.93 (0.25)

34. Secondary Outcome

Title	Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52
Description	Change in VLDL cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	10	12	5	28	15
Mean (Standard Deviation) [Ratio of VLDL cholesterol]	1.06 (0.35)	0.95 (0.36)	1.03 (0.26)	1.13 (0.31)	1.04 (0.31)	1.01 (0.34)

35. Secondary Outcome

Title	Change in Triglycerides From Baseline at Week 16
Description	Change in triglycerides (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	12	12	5	29	17
Mean (Standard Deviation) [Ratio of triglycerides]	1.04 (0.36)	0.99 (0.26)	1.05 (0.44)	0.80 (0.18)	1.05 (0.39)	0.93 (0.25)

36. Secondary Outcome

Title	Change in Triglycerides From Baseline at Week 52
Description	Change in triglycerides (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	10	12	5	28	15
Mean (Standard Deviation) [Ratio of triglycerides]	1.07 (0.36)	0.94 (0.36)	1.04 (0.29)	1.12 (0.32)	1.06 (0.32)	1.00 (0.35)

37. Secondary Outcome

Title	Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16
Description	Change in free fatty acids (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	11	13	5	29	16
Mean (Standard Deviation) [Ratio of FFA]	1.52 (1.60)	1.31 (0.61)	1.04 (0.35)	0.99 (0.30)	1.31 (1.21)	1.21 (0.55)

38. Secondary Outcome

Title	Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52
Description	Change in free fatty acids (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	15	8	12	4	27	12
Mean (Standard Deviation) [Ratio of FFA]	1.15 (0.76)	1.45 (0.49)	0.85 (0.51)	1.05 (0.25)	1.01 (0.67)	1.32 (0.45)

39. Secondary Outcome

Title	Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16
Description	Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	12	15	7	33	19
SBP: Change from week 0 to week 16	-5 (15)	-2 (13)	2 (9)	2 (6)	-1 (13)	-1 (11)
DBP: Change from week 0 to week 16	-1 (10)	0 (7)	1 (8)	-1 (17)	0 (9)	0 (11)

40. Secondary Outcome

Title	Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52
Description	Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	13	5	30	16
SBP: Change from week 0 to week 52	-5 (6)	4 (12)	4 (15)	7 (8)	-1 (11)	5 (11)
DBP: Change from week 0 to week 52	-3 (9)	5 (13)	4 (13)	1 (7)	0 (11)	4 (12)

41. Secondary Outcome

Title	Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16
Description	Change in HbA1c from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	12	13	7	29	19
Mean (Standard Deviation) [Percentage point of HbA1c]	-0.2 (0.1)	0 (0.3)	-0.2 (0.3)	-0.2 (0.3)	-0.2 (0.2)	-0.1 (0.3)

42. Secondary Outcome

Title	Change in HbA1c From Baseline at Week 52
Description	Change in HbA1c from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	9	12	5	28	14
Mean (Standard Deviation) [Percentage point of HbA1c]	-0.2 (0.2)	0.1 (0.3)	-0.2 (0.4)	-0.1 (0.3)	-0.2 (0.3)	0.1 (0.3)

43. Secondary Outcome

Title	Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16
Description	Change in FPG from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	11	13	5	31	16
Mean (Standard Deviation) [mmol/L]	-0.2 (0.5)	0.1 (0.5)	-0.1 (0.5)	0.2 (0.4)	-0.2 (0.5)	0.1 (0.4)

44. Secondary Outcome

Title	Change in FPG From Baseline at Week 52
Description	Change in FPG from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	15	9	12	5	27	14
Mean (Standard Deviation) [mmol/L]	0 (0.7)	0.3 (0.8)	0 (0.4)	0 (0.4)	0 (0.6)	0.2 (0.7)

45. Secondary Outcome

Title	Change in Fasting Insulin From Baseline at Week 16
Description	Change in fasting insulin (measured as picomoles per litre (pmol/L)) from baseline to week 16 is presented as ratio to baseline.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	11	13	6	31	17
Mean (Standard Deviation) [Ratio of fasting insulin]	1.59 (1.91)	0.78 (0.32)	1.43 (1.17)	1.32 (0.68)	1.52 (1.62)	0.97 (0.53)

46. Secondary Outcome

Title	Change in Fasting Insulin From Baseline at Week 52
Description	Change in fasting insulin (measured as picomoles per litre (pmol/L)) from baseline to week 52 is presented as ratio to baseline.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	8	12	5	28	13
Mean (Standard Deviation) [Ratio of fasting insulin]	2.03 (2.33)	0.79 (0.37)	1.45 (1.27)	1.22 (0.44)	1.78 (1.94)	0.96 (0.44)

47. Secondary Outcome

Title	Change in Fasting C Peptide From Baseline at Week 16
Description	Change in fasting C peptide (measured as nano moles per liter (nmol/L)) from baseline to week 16 is presented as ratio to baseline.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	11	12	6	30	17
Mean (Standard Deviation) [Ratio of fasting C peptide]	1.14 (0.56)	0.86 (0.20)	1.11 (0.50)	1.08 (0.44)	1.13 (0.53)	0.94 (0.31)

48. Secondary Outcome

Title	Change in Fasting C Peptide From Baseline at Week 52
Description	Change in fasting C peptide (measured as nano moles per liter (nmol/L)) from baseline to week 52 is presented as ratio to baseline.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	8	12	5	28	13
Mean (Standard Deviation) [Ratio of fasting C peptide]	1.34 (0.92)	0.91 (0.23)	1.15 (0.45)	1.09 (0.30)	1.26 (0.75)	0.98 (0.26)

49. Secondary Outcome

Title	Number of Participants in Glycaemic Category at Week 16
Description	Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 16 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG <5.6 mmol/L (<100 mg/dL) and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes: FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%.
Time Frame	week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	12	13	7	31	19
Normoglycaemia	16 84.2%	8 66.7%	11 64.7%	5 71.4%	27 49.1%	13 NaN
Pre-diabetes	2 10.5%	4 33.3%	2 11.8%	2 28.6%	4 7.3%	6 NaN
Type 2 diabetes	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN

50. Secondary Outcome

Title	Number of Participants in Glycaemic Category at Week 52
Description	Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG <5.6 mmol/L (<100 mg/dL) and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes: FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	9	12	5	28	14
Normoglycaemia	13 68.4%	4 33.3%	10 58.8%	2 28.6%	23 41.8%	6 NaN
Pre-diabetes	2 10.5%	4 33.3%	2 11.8%	3 42.9%	4 7.3%	7 NaN
Type 2 diabetes	1 5.3%	1 8.3%	0 0%	0 0%	1 1.8%	1 NaN

51. Secondary Outcome

Title	Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16
Description	Change in HOMA-B from baseline to week 16 is presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5).
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	10	13	5	31	15
Mean (Standard Deviation) [Ratio of HOMA-B]	1.69 (1.93)	0.70 (0.31)	1.55 (1.04)	1.07 (0.51)	1.63 (1.59)	0.82 (0.41)

52. Secondary Outcome

Title	Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52
Description	Change in HOMA-B from baseline to week 52 is presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5).
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	15	8	12	5	27	13
Mean (Standard Deviation) [Ratio of HOMA-B]	2.24 (1.85)	0.65 (0.30)	1.50 (1.50)	1.25 (0.50)	1.91 (1.71)	0.88 (0.48)

53. Secondary Outcome

Title	Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16
Description	Change in HOMA-IR from baseline to week 16 is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	10	13	5	31	15
Mean (Standard Deviation) [Ratio of HOMA-IR]	1.57 (1.92)	0.80 (0.35)	1.43 (1.26)	1.33 (0.82)	1.51 (1.65)	0.97 (0.58)

54. Secondary Outcome

Title	Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52
Description	Change in HOMA-IR from baseline to week 52 is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	15	8	12	5	27	13
Mean (Standard Deviation) [Ratio of HOMA-IR]	2.26 (3.13)	0.88 (0.50)	1.45 (1.23)	1.24 (0.48)	1.90 (2.46)	1.02 (0.51)

55. Secondary Outcome

Title	Number of Treatment Emergent Adverse Events
Description	An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period included AEs are with an onset date on or after the first day of trial product administration and any of the following dates, whichever came first: a) 14 days after the last day on trial product, or b) Follow-up visit (week 54) for participants with trial product discontinuation, or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Time Frame	From week 0 to week 54

Outcome Measure Data

Analysis Population Description

Safety analysis set (SAS) which included all participants exposed to at least one dose of trial product. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	20	12	17	7	37	19
Number [Events]	134	37	159	8	293	45

56. Secondary Outcome

Title	Number of Severe Treatment Emergent Episodes of Hypoglycaemia
Description	Hypoglycaemic episode (blood glucose less than or equal to (<=) 3.9 mmol/L (70 mg/dL) Or greater than (>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Severe hypoglycaemia defined by American Diabetes Association (ADA) 2013 and International Society for Paediatric and Adolescent Diabetes (ISPAD) 2018: hypoglycaemic episode associated with severe cognitive impairment requiring external assistance for recovery. Endpoint was evaluated based on data from in-trial period which was defined as events with onset date on or after the first day of trial product administration and no later than the last study visit (week 54).
Time Frame	From week 0 to week 54

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	20	12	17	7	37	19
Number [Episodes]	0	0	1	0	1	0

57. Secondary Outcome

Title	Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia
Description	Symptomatic blood glucose confirmed hypoglycaemia: An episode that is blood glucose confirmed by plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Endpoint was evaluated based on data from in-trial period which was defined as events with onset date on or after the first day of trial product administration and no later than the last study visit (week 54).
Time Frame	From week 0 to week 54

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	20	12	17	7	37	19
Number [Episodes]	0	0	0	0	0	0

58. Secondary Outcome

Title	Number of Participants With Occurrence of Anti-liraglutide Antibodies
Description	Number of participants with occurrence of anti-liraglutide antibodies is presented. In the below table, 'Yes' infers number of participants with occurrence of anti- liraglutide antibodies and 'No' infers number of participants without anti- liraglutide antibodies.
Time Frame	From week 0 to week 54

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall number of participants analysed = Number of participants with available data. Combined data of Part A and B for liraglutide was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part B: Liraglutide	Part A+B: Liraglutide
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).
Measure Participants	16	9	25
Yes	2 10.5%	1 8.3%	3 17.6%
No	14 73.7%	8 66.7%	22 129.4%

59. Secondary Outcome

Title	Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16
Description	A 12-lead ECG was performed at baseline (week 0) and week 16 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Number of participants in each ECG category at week 0 and weeks 16 are presented.
Time Frame	Week 0, Week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	20	12	17	7	37	19
Week 0: Normal	20 105.3%	12 100%	17 100%	6 85.7%	37 67.3%	18 NaN
Week 0: Abnormal, NCS	0 0%	0 0%	0 0%	1 14.3%	0 0%	1 NaN
Week 0: Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Week 16: Normal	17 89.5%	12 100%	13 76.5%	7 100%	30 54.5%	19 NaN
Week 16: Abnormal, NCS	0 0%	0 0%	1 5.9%	0 0%	1 1.8%	0 NaN
Week 16: Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN

60. Secondary Outcome

Title	Number of Participants With Change in ECG From Baseline at Week 52
Description	A 12-lead ECG was performed at baseline (week 0) and week 52 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Number of participants in each ECG category at week 0 and week 52 are presented.
Time Frame	Week 0, Week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	20	12	17	7	37	19
Week 0: Normal	20 105.3%	12 100%	17 100%	6 85.7%	37 67.3%	18 NaN
Week 0: Abnormal, NCS	0 0%	0 0%	0 0%	1 14.3%	0 0%	1 NaN
Week 0: Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Week 52: Normal	17 89.5%	9 75%	13 76.5%	4 57.1%	30 54.5%	13 NaN
Week 52: Abnormal, NCS	1 5.3%	1 8.3%	0 0%	0 0%	1 1.8%	1 NaN
Week 52: Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN

61. Secondary Outcome

Title	Change in Pulse From Baseline at Week 16
Description	Change in pulse from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	12	15	7	33	19
Mean (Standard Deviation) [Beats/minute]	2 (12)	-2 (5)	1 (16)	-9 (10)	2 (14)	-4 (8)

62. Secondary Outcome

Title	Change in Pulse From Baseline at Week 52
Description	Change in pulse from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	13	5	30	16
Mean (Standard Deviation) [Beats/minute]	1 (13)	-8 (10)	10 (11)	-6 (8)	5 (13)	-7 (10)

63. Secondary Outcome

Title	Change in Haematology: Haemoglobin From Baseline at Week 16
Description	Change in haemoglobin from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	11	12	6	28	17
Mean (Standard Deviation) [millimoles per liter (mmol/L)]	-0.18 (0.43)	0.06 (0.28)	-0.20 (1.22)	-0.07 (0.55)	-0.19 (0.84)	0.01 (0.38)

64. Secondary Outcome

Title	Change in Haematology: Haemoglobin From Baseline at Week 52
Description	Change in haemoglobin from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	15	9	10	4	25	13
Mean (Standard Deviation) [mmol/L]	-0.14 (0.79)	-0.01 (0.31)	-0.02 (0.61)	-0.02 (0.20)	-0.09 (0.72)	-0.01 (0.28)

65. Secondary Outcome

Title	Change in Haematology: Haematocrit From Baseline at Week 16
Description	Change in haematocrit from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	11	12	6	28	17
Mean (Standard Deviation) [Percentage of haematocrit in blood]	-1.8 (2.1)	-0.5 (1.3)	0.4 (2.6)	-0.6 (3.3)	-0.9 (2.6)	-0.5 (2.1)

66. Secondary Outcome

Title	Change in Haematology: Haematocrit From Baseline at Week 52
Description	Change in haematocrit from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	15	9	10	4	25	13
Mean (Standard Deviation) [Percentage of haematocrit in blood]	-1.4 (4.0)	0 (1.7)	-0.2 (2.7)	-0.8 (2.6)	-0.9 (3.5)	-0.3 (1.9)

67. Secondary Outcome

Title	Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16
Description	Change in thrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	11	12	6	28	17
Thrombocytes: Change from week 0 to week 16	6 (35)	-21 (26)	8 (66)	19 (18)	7 (49)	-8 (30)
Leukocytes: Change from week 0 to week 16	-0.1 (1.5)	-0.3 (1.6)	-0.8 (2.3)	-1.1 (1.7)	-0.4 (1.9)	-0.6 (1.6)
Eosinophils: Change from week 0 to week 16	-0.03 (0.09)	0.04 (0.07)	-0.14 (0.27)	0.07 (0.32)	-0.07 (0.20)	0.05 (0.19)
Neutrophils: Change from week 0 to week 16	0.11 (1.08)	-0.22 (1.62)	-0.28 (1.59)	-1.35 (1.33)	-0.06 (1.31)	-0.62 (1.58)
Basophils: Change from week 0 to week 16	-0.01 (0.02)	0 (0.02)	-0.01 (0.04)	-0.01 (0.04)	-0.01 (0.03)	0 (0.03)
Lymphocytes: Change from week 0 to week 16	-0.24 (0.66)	-0.09 (0.97)	-0.36 (0.89)	0.09 (0.85)	-0.29 (0.76)	-0.02 (0.91)
Monocytes: Change from week 0 to week 16	0.06 (0.17)	-0.04 (0.12)	-0.05 (0.17)	0.05 (0.20)	0.01 (0.18)	-0.01 (0.15)

68. Secondary Outcome

Title	Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52
Description	Change in thrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	15	9	10	4	25	13
Thrombocytes: Change from week 0 to week 52	18 (44)	-7 (39)	-2 (37)	37 (70)	10 (42)	5 (49)
Leukocytes: Change from week 0 to week 52	-0.2 (1.1)	-0.6 (1.7)	-0.7 (2.8)	0.3 (3.0)	-0.4 (1.9)	-0.3 (2.1)
Eosinophils: Change from week 0 to week 52	0.01 (0.11)	0.03 (0.19)	-0.13 (0.36)	-0.17 (0.13)	-0.05 (0.24)	-0.03 (0.20)
Neutrophils: Change from week 0 to week 52	0.11 (1.17)	-0.76 (1.40)	-0.03 (2.03)	-0.07 (2.55)	0.05 (1.53)	-0.55 (1.75)
Basophils: Change from week 0 to week 52	0 (0.03)	0 (0.04)	-0.01 (0.04)	0.02 (0.04)	-0.01 (0.04)	0.01 (0.04)
Lymphocytes: Change from week 0 to week 52	-0.28 (0.67)	0.19 (0.70)	-0.47 (0.59)	0.39 (0.49)	-0.36 (0.63)	0.25 (0.63)
Monocytes: Change from week 0 to week 52	-0.04 (0.19)	-0.06 (0.22)	-0.05 (0.19)	0.14 (0.20)	-0.04 (0.19)	0 (0.23)

69. Secondary Outcome

Title	Change in Haematology: Erythrocytes From Baseline at Week 16
Description	Change in erythrocytes from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	11	12	6	28	17
Mean (Standard Deviation) [10^12 cells per liter (10^12/L)]	-0.1 (0.2)	0 (0.2)	0.1 (0.3)	0 (0.3)	-0.1 (0.3)	0 (0.2)

70. Secondary Outcome

Title	Change in Haematology: Erythrocytes From Baseline at Week 52
Description	Change in erythrocytes from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	15	9	10	4	25	13
Mean (Standard Deviation) [10^12 cells per liter (10^12/L)]	-0.1 (0.4)	0 (0.2)	-0.1 (0.3)	0 (0)	-0.1 (0.4)	0 (0.1)

71. Secondary Outcome

Title	Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16
Description	Change in creatinine and bilirubin (total) from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	12	11	6	28	18
Creatinine: Change from week 0 to week 16	1 (5)	0 (6)	2 (7)	0 (6)	1 (5)	0 (6)
Bilirubin (total): Change from week 0 to week 16	0 (2)	0 (2)	0 (2)	1 (2)	0 (2)	0 (2)

72. Secondary Outcome

Title	Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52
Description	Change in creatinine and bilirubin (total) from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	10	11	5	27	15
Creatinine: Change from week 0 to week 52	3 (8)	-4 (9)	3 (6)	5 (3)	3 (7)	-1 (9)
Bilirubin (total): Change from week 0 to week 52	0 (2)	2 (3)	0 (1)	2 (3)	0 (2)	2 (3)

73. Secondary Outcome

Title	Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16
Description	Change in creatine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	12	11	6	28	18
Creatinine kinase: Change from week 0 to week 16	-3 (37)	16 (45)	3 (23)	-5 (5)	-1 (32)	10 (39)
Amylase: Change from week 0 to week 16	5 (13)	-2 (5)	8 (12)	8 (8)	6 (13)	1 (8)
Lipase: Change from week 0 to week 16	10 (6)	0 (4)	8 (7)	1 (2)	9 (6)	0 (3)
ALT: Change from week 0 to week 16	-9 (32)	-4 (18)	-2 (6)	-25 (23)	-6 (25)	-10 (21)
AST: Change from week 0 to week 16	-6 (14)	0 (10)	-2 (5)	-18 (24)	-4 (11)	-6 (17)
ALP: Change from week 0 to week 16	-10 (12)	-7 (25)	-21 (36)	-47 (42)	-14 (24)	-19 (35)

74. Secondary Outcome

Title	Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52
Description	Change in creatine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	10	11	5	27	15
Creatinine kinase: Change from week 0 to week 52	30 (206)	-4 (29)	25 (42)	-8 (25)	28 (159)	-5 (27)
Amylase: Change from week 0 to week 52	4 (10)	2 (12)	7 (12)	8 (5)	5 (11)	4 (11)
Lipase: Change from week 0 to week 52	9 (9)	-1 (3)	7 (6)	3 (5)	8 (8)	0 (4)
ALT: Change from week 0 to week 52	1 (12)	4 (25)	0 (16)	-24 (28)	1 (14)	-6 (29)
AST: Change from week 0 to week 52	-2 (7)	9 (31)	1 (7)	-21 (32)	-1 (7)	0 (33)
ALP: Change from week 0 to week 52	-24 (27)	-35 (27)	-25 (59)	-26 (60)	-24 (42)	-32 (39)

75. Secondary Outcome

Title	Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16
Description	Change in urea, sodium, potassium, calcium total and calcium albumin-corrected from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	12	11	6	28	18
Urea: Change from week 0 to week 16	0.03 (1.45)	-0.51 (0.67)	0 (0.99)	0.09 (2.19)	0.02 (1.26)	-0.31 (1.33)
Sodium: Change from week 0 to week 16	0 (5)	2 (3)	1 (4)	0 (1)	0 (4)	1 (3)
Potassium: Change from week 0 to week 16	0.1 (0.4)	-0.1 (0.3)	-0.2 (0.6)	-0.1 (0.2)	0 (0.5)	-0.1 (0.2)
Calcium: Change from week 0 to week 16	0 (0.12)	0 (0.10)	0.08 (0.17)	0.02 (0.10)	0.03 (0.14)	0.01 (0.10)

76. Secondary Outcome

Title	Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52
Description	Change in urea, sodium, potassium, calcium total and calcium albumin-corrected from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	10	11	5	27	15
Urea: Change from week 0 to week 52	-0.38 (1.56)	-0.34 (0.54)	-0.21 (1.00)	-0.04 (1.08)	-0.31 (1.34)	-0.24 (0.74)
Sodium: Change from week 0 to week 52	-1 (5)	-2 (5)	1 (4)	2 (2)	0 (4)	-1 (4)
Potassium: Change from week 0 to week 52	-0.2 (0.6)	-0.1 (0.2)	-0.2 (0.7)	0 (0.2)	-0.2 (0.6)	-0.1 (0.2)
Calcium: Change from week 0 to week 52	-0.05 (0.14)	-0.11 (0.12)	0.09 (0.14)	0 (0.02)	0.01 (0.15)	-0.08 (0.11)

77. Secondary Outcome

Title	Change in Biochemistry: Albumin From Baseline at Week 16
Description	Change in albumin from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	12	11	5	28	17
Mean (Standard Deviation) [gram per deciliter (g/dL)]	0 (0.2)	0 (0.1)	0 (0.2)	0 (0.1)	0 (0.2)	0 (0.1)

78. Secondary Outcome

Title	Change in Biochemistry: Albumin From Baseline at Week 52
Description	Change in albumin from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	10	11	5	27	15
Mean (Standard Deviation) [g/dL]	-0.1 (0.7)	-0.1 (0.3)	0 (0.2)	0 (0.1)	0 (0.5)	-0.1 (0.2)

79. Secondary Outcome

Title	Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16
Description	Change in CEA serum from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	9	13	6	30	15
Mean (Standard Deviation) [nanogram per milliliter (ng/mL)]	-0.01 (0.11)	-0.17 (0.30)	0.17 (0.55)	-0.04 (0.10)	0.07 (0.38)	-0.12 (0.24)

80. Secondary Outcome

Title	Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52
Description	Change in CEA serum from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	15	7	12	5	27	12
Mean (Standard Deviation) [ng/mL]	0.03 (0.38)	-0.14 (0.26)	-0.01 (0.14)	0.17 (0.24)	0.01 (0.29)	-0.01 (0.29)

81. Secondary Outcome

Title	Change in Hormone Level: Calcitonin From Baseline at Week 16
Description	Change in calcitonin from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	11	6	28	17
Mean (Standard Deviation) [nanogram per liter (ng/L)]	0 (0)	0 (0)	0.3 (1.1)	0 (0)	0.1 (0.7)	0 (0)

82. Secondary Outcome

Title	Change in Hormone Level: Calcitonin From Baseline at Week 52
Description	Change in calcitonin from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	7	11	5	27	12
Mean (Standard Deviation) [ng/L]	0.1 (0.6)	0 (0)	0.5 (1.2)	0 (0)	0.3 (0.9)	0 (0)

83. Secondary Outcome

Title	Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16
Description	Change in TSH and prolactin from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	12	13	7	30	19
TSH: Change from week 0 to week 16	-0.34 (0.68)	-0.01 (0.72)	-0.09 (1.13)	-0.59 (0.67)	-0.23 (0.89)	-0.23 (0.74)
Prolactin: Change from week 0 to week 16	7 (27)	-6 (33)	0 (13)	-22 (63)	4 (22)	-12 (45)

84. Secondary Outcome

Title	Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52
Description	Change in TSH and prolactin from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	10	11	5	27	15
TSH: Change from week 0 to week 52	0.02 (1.59)	-0.48 (0.63)	-0.75 (2.13)	-0.17 (1.08)	-0.30 (1.83)	-0.38 (0.78)
Prolactin: Change from week 0 to week 52	10 (38)	8 (37)	-3 (37)	29 (33)	5 (37)	15 (36)

85. Secondary Outcome

Title	Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16
Description	Change in free T4 and ACTH from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	12	13	7	31	19
T4: Change from week 0 to week 16	-0.6 (1.4)	0.3 (1.1)	0.7 (2.3)	0.1 (1.7)	-0.1 (1.9)	0.2 (1.3)
ACTH: Change from week 0 to week 16	0.99 (5.22)	-0.85 (2.22)	-0.37 (1.49)	-1.32 (1.87)	0.42 (4.10)	-1.02 (2.04)

86. Secondary Outcome

Title	Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52
Description	Change in free T4 and ACTH from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	10	12	5	27	15
T4: Change from week 0 to week 52	-0.4 (1.7)	1.9 (2.7)	-0.1 (2.0)	0.8 (2.3)	-0.3 (1.8)	1.5 (2.5)
ACTH: Change from week 0 to week 52	-0.02 (2.02)	1.29 (3.50)	0.98 (5.64)	0.20 (2.41)	0.42 (3.99)	0.89 (3.07)

87. Secondary Outcome

Title	Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16
Description	Change in IGF-1 and cortisol from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	11	13	7	31	18
IGF-1: Change from week 0 to week 16	-56.89 (126.46)	-28.23 (95.79)	2.41 (84.98)	-14.23 (75.01)	-30.31 (112.09)	-23.86 (87.54)
Cortisol: Change from week 0 to week 16	-22.94 (41.36)	6.75 (38.72)	-8.09 (22.98)	-23.08 (59.02)	-16.71 (35.16)	-4.85 (48.33)

88. Secondary Outcome

Title	Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52
Description	Change in IGF-1 and cortisol from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	9	12	5	28	14
IGF-1: Change from week 0 to week 52	-25.90 (195.61)	-103.45 (136.61)	-1.47 (112.93)	10.40 (56.69)	-15.04 (161.72)	-59.66 (123.62)
Cortisol: Change from week 0 to week 52	3.60 (50.63)	7.54 (33.71)	-14.15 (43.84)	21.67 (46.62)	-4.01 (47.82)	12.59 (37.65)

89. Secondary Outcome

Title	Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16
Description	Change in DHEAS from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	11	13	5	31	16
Mean (Standard Deviation) [umol/L]	0.16 (1.74)	0.21 (0.95)	0.25 (1.10)	1.00 (1.42)	0.20 (1.48)	0.46 (1.13)

90. Secondary Outcome

Title	Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52
Description	Change in DHEAS from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	8	12	4	28	12
Mean (Standard Deviation) [umol/L]	0.77 (1.18)	0.76 (0.97)	0.25 (0.66)	0.74 (1.26)	0.55 (1.01)	0.76 (1.01)

91. Secondary Outcome

Title	Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16
Description	Change in LH and FSH from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	12	13	7	30	19
LH: Change from week 0 to week 16	-0.04 (1.28)	0.06 (0.74)	-0.07 (0.25)	0.22 (0.42)	-0.05 (0.97)	0.12 (0.63)
FSH: Change from week 0 to week 16	-0.2 (2.5)	0.2 (1.0)	-0.1 (1.3)	1.0 (1.1)	-0.2 (2.1)	0.5 (1.1)

92. Secondary Outcome

Title	Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52
Description	Change in LH and FSH from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	16	10	11	5	27	15
LH: Change from week 0 to week 52	0.16 (2.33)	0.06 (0.79)	0.37 (0.96)	0.30 (0.51)	0.24 (1.87)	0.14 (0.70)
FSH: Change from week 0 to week 52	1.1 (3.9)	0.4 (1.6)	0.4 (1.8)	0.7 (1.6)	0.8 (3.1)	0.6 (1.5)

93. Secondary Outcome

Title	Change in Hormone Level: Estradiol (Females) From Baseline at Week 16
Description	Change in estradiol (only for females) from baseline to week 16 is presented.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of female participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	9	4	6	2	15	6
Mean (Standard Deviation) [picograms per milliliter (pg/mL)]	0.9 (15.8)	9.2 (11.9)	1.6 (3.8)	0 (0)	1.2 (12.2)	6.1 (10.4)

94. Secondary Outcome

Title	Change in Hormone Level: Estradiol (Females) From Baseline at Week 52
Description	Change in estradiol (only for females) from baseline to week 52 is presented.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of female participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	7	4	8	1	15	5
Mean (Standard Deviation) [pg/mL]	7.0 (32.6)	13.7 (21.6)	1.6 (4.5)	0 (NA)	4.1 (21.8)	11.0 (19.7)

95. Secondary Outcome

Title	Change in Hormone Level: Testosterone (Males) From Baseline at Week 16
Description	Change in testosterone (only for males) from baseline to week 16 is presented. The testosterone analysis for Part B could not be performed due to an unforeseen change in the assay used by the central laboratory to measure testosterone during the trial. This change in methodology prevented a direct comparison of values measured at different time points during the trial.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of male participants who contributed to the analysis.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
Measure Participants	8	7
Mean (Standard Deviation) [nanomoles per liter (nmol/L)]	1.55 (2.01)	0.61 (1.66)

96. Secondary Outcome

Title	Change in Hormone Level: Testosterone (Males) From Baseline at Week 52
Description	Change in testosterone (only for males) from baseline to week 52 is presented. The testosterone analysis for Part B could not be performed due to an unforeseen change in the assay used by the central laboratory to measure testosterone during the trial. This change in methodology prevented a direct comparison of values measured at different time points during the trial.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of male participants who contributed to the analysis.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
Measure Participants	8	5
Mean (Standard Deviation) [nmol/L]	0.62 (1.40)	-0.34 (1.51)

97. Secondary Outcome

Title	Number of Participants With Change in Pubertal Status From Baseline at Week 16
Description	This outcome measure presents "pubertal status results" which is based on Tanner staging recorded at baseline (week 0), week 16. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Results are presented for the following categories: 1) For female: breast development and pubic hair development, 2) For male: penis development and pubic hair development. Each category shows number of participants in stages 1 to 5, where stage 1 represents "early pubertal development" and stage 5 represents "pubertal development equivalent to that of an adult".
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	11	7	11	5	22	12
Stage 1	0 0%	0 0%	11 64.7%	2 28.6%	11 20%	2 NaN
Stage 2	1 5.3%	0 0%	0 0%	0 0%	1 1.8%	0 NaN
Stage 3	8 42.1%	2 16.7%	0 0%	0 0%	8 14.5%	2 NaN
Stage 4	0 0%	1 8.3%	0 0%	0 0%	0 0%	1 NaN
Stage 5	2 10.5%	2 16.7%	0 0%	0 0%	2 3.6%	2 NaN
Stage 1	0 0%	0 0%	6 35.3%	2 28.6%	6 10.9%	2 NaN
Stage 2	1 5.3%	0 0%	3 17.6%	0 0%	4 7.3%	0 NaN
Stage 3	7 36.8%	1 8.3%	0 0%	0 0%	7 12.7%	1 NaN
Stage 4	0 0%	2 16.7%	0 0%	0 0%	0 0%	2 NaN
Stage 5	2 10.5%	2 16.7%	0 0%	0 0%	2 3.6%	2 NaN
Stage 1	1 5.3%	0 0%	6 35.3%	1 14.3%	7 12.7%	1 NaN
Stage 2	2 10.5%	0 0%	3 17.6%	0 0%	5 9.1%	0 NaN
Stage 3	3 15.8%	2 16.7%	0 0%	1 14.3%	3 5.5%	3 NaN
Stage 4	3 15.8%	1 8.3%	2 11.8%	0 0%	5 9.1%	1 NaN
Stage 5	2 10.5%	2 16.7%	0 0%	0 0%	2 3.6%	2 NaN
Stage 1	1 5.3%	0 0%	3 17.6%	1 14.3%	4 7.3%	1 NaN
Stage 2	1 5.3%	0 0%	5 29.4%	0 0%	6 10.9%	0 NaN
Stage 3	4 21.1%	1 8.3%	0 0%	1 14.3%	4 7.3%	2 NaN
Stage 4	2 10.5%	2 16.7%	1 5.9%	0 0%	3 5.5%	2 NaN
Stage 5	2 10.5%	2 16.7%	0 0%	0 0%	2 3.6%	2 NaN
Stage 1	0 0%	0 0%	6 35.3%	3 42.9%	6 10.9%	3 NaN
Stage 2	3 15.8%	0 0%	0 0%	1 14.3%	3 5.5%	1 NaN
Stage 3	2 10.5%	4 33.3%	0 0%	1 14.3%	2 3.6%	5 NaN
Stage 4	2 10.5%	2 16.7%	0 0%	0 0%	2 3.6%	2 NaN
Stage 5	2 10.5%	1 8.3%	0 0%	0 0%	2 3.6%	1 NaN
Stage 1	0 0%	0 0%	6 35.3%	1 14.3%	6 10.9%	1 NaN
Stage 2	2 10.5%	0 0%	0 0%	3 42.9%	2 3.6%	3 NaN
Stage 3	2 10.5%	3 25%	0 0%	1 14.3%	2 3.6%	4 NaN
Stage 4	2 10.5%	2 16.7%	0 0%	0 0%	2 3.6%	2 NaN
Stage 5	3 15.8%	2 16.7%	0 0%	0 0%	3 5.5%	2 NaN
Stage 1	0 0%	1 8.3%	6 35.3%	5 71.4%	6 10.9%	6 NaN
Stage 2	4 21.1%	3 25%	0 0%	0 0%	4 7.3%	3 NaN
Stage 3	1 5.3%	1 8.3%	0 0%	0 0%	1 1.8%	1 NaN
Stage 4	3 15.8%	2 16.7%	0 0%	0 0%	3 5.5%	2 NaN
Stage 5	1 5.3%	0 0%	0 0%	0 0%	1 1.8%	0 NaN
Stage 1	0 0%	1 8.3%	5 29.4%	5 71.4%	5 9.1%	6 NaN
Stage 2	2 10.5%	1 8.3%	1 5.9%	0 0%	3 5.5%	1 NaN
Stage 3	2 10.5%	3 25%	0 0%	0 0%	2 3.6%	3 NaN
Stage 4	2 10.5%	1 8.3%	0 0%	0 0%	2 3.6%	1 NaN
Stage 5	3 15.8%	1 8.3%	0 0%	0 0%	3 5.5%	1 NaN

98. Secondary Outcome

Title	Number of Participants With Change in Pubertal Status From Baseline at Week 52
Description	This outcome measure presents "pubertal status results" which is based on Tanner staging recorded at baseline (week 0) and week 52. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Results are presented for the following categories: 1) For female: breast development and pubic hair development, 2) For male: penis development and pubic hair development. Each category shows number of participants in stages 1 to 5, where stage 1 represents "early pubertal development" and stage 5 represents "pubertal development equivalent to that of an adult".
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	11	7	11	5	22	12
Stage 1	0 0%	0 0%	11 64.7%	2 28.6%	11 20%	2 NaN
Stage 2	1 5.3%	0 0%	0 0%	0 0%	1 1.8%	0 NaN
Stage 3	8 42.1%	2 16.7%	0 0%	0 0%	8 14.5%	2 NaN
Stage 4	0 0%	1 8.3%	0 0%	0 0%	0 0%	1 NaN
Stage 5	2 10.5%	2 16.7%	0 0%	0 0%	2 3.6%	2 NaN
Stage 1	0 0%	0 0%	2 11.8%	1 14.3%	2 3.6%	1 NaN
Stage 2	0 0%	0 0%	4 23.5%	0 0%	4 7.3%	0 NaN
Stage 3	5 26.3%	1 8.3%	2 11.8%	0 0%	7 12.7%	1 NaN
Stage 4	1 5.3%	2 16.7%	0 0%	0 0%	1 1.8%	2 NaN
Stage 5	3 15.8%	2 16.7%	0 0%	0 0%	3 5.5%	2 NaN
Stage 1	1 5.3%	0 0%	6 35.3%	1 14.3%	7 12.7%	1 NaN
Stage 2	2 10.5%	0 0%	3 17.6%	0 0%	5 9.1%	0 NaN
Stage 3	3 15.8%	2 16.7%	0 0%	1 14.3%	3 5.5%	3 NaN
Stage 4	3 15.8%	1 8.3%	2 11.8%	0 0%	5 9.1%	1 NaN
Stage 5	2 10.5%	2 16.7%	0 0%	0 0%	2 3.6%	2 NaN
Stage 1	1 5.3%	0 0%	1 5.9%	0 0%	2 3.6%	0 NaN
Stage 2	1 5.3%	0 0%	2 11.8%	0 0%	3 5.5%	0 NaN
Stage 3	2 10.5%	1 8.3%	4 23.5%	1 14.3%	6 10.9%	2 NaN
Stage 4	3 15.8%	2 16.7%	1 5.9%	0 0%	4 7.3%	2 NaN
Stage 5	2 10.5%	2 16.7%	0 0%	0 0%	2 3.6%	2 NaN
Stage 1	0 0%	0 0%	6 35.3%	3 42.9%	6 10.9%	3 NaN
Stage 2	3 15.8%	0 0%	0 0%	1 14.3%	3 5.5%	1 NaN
Stage 3	2 10.5%	4 33.3%	0 0%	1 14.3%	2 3.6%	5 NaN
Stage 4	2 10.5%	2 16.7%	0 0%	0 0%	2 3.6%	2 NaN
Stage 5	2 10.5%	1 8.3%	0 0%	0 0%	2 3.6%	1 NaN
Stage 1	0 0%	0 0%	4 23.5%	0 0%	4 7.3%	0 NaN
Stage 2	0 0%	0 0%	1 5.9%	1 14.3%	1 1.8%	1 NaN
Stage 3	3 15.8%	2 16.7%	0 0%	1 14.3%	3 5.5%	3 NaN
Stage 4	3 15.8%	3 25%	0 0%	1 14.3%	3 5.5%	4 NaN
Stage 5	3 15.8%	1 8.3%	0 0%	0 0%	3 5.5%	1 NaN
Stage 1	0 0%	1 8.3%	6 35.3%	5 71.4%	6 10.9%	6 NaN
Stage 2	4 21.1%	3 25%	0 0%	0 0%	4 7.3%	3 NaN
Stage 3	1 5.3%	1 8.3%	0 0%	0 0%	1 1.8%	1 NaN
Stage 4	3 15.8%	2 16.7%	0 0%	0 0%	3 5.5%	2 NaN
Stage 5	1 5.3%	0 0%	0 0%	0 0%	1 1.8%	0 NaN
Stage 1	0 0%	1 8.3%	3 17.6%	2 28.6%	3 5.5%	3 NaN
Stage 2	1 5.3%	1 8.3%	2 11.8%	1 14.3%	3 5.5%	2 NaN
Stage 3	2 10.5%	1 8.3%	0 0%	0 0%	2 3.6%	1 NaN
Stage 4	3 15.8%	2 16.7%	0 0%	0 0%	3 5.5%	2 NaN
Stage 5	3 15.8%	1 8.3%	0 0%	0 0%	3 5.5%	1 NaN

99. Secondary Outcome

Title	Number of Participants With Change in Physical Examination From Baseline at Week 16
Description	This outcome measure presents number of participants with physical examination findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" at baseline (week 0), week 16. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	20	12	17	7	37	19
Normal	14 73.7%	10 83.3%	12 70.6%	5 71.4%	26 47.3%	15 NaN
Abnormal, NCS	2 10.5%	1 8.3%	3 17.6%	1 14.3%	5 9.1%	2 NaN
Abnormal, CS	4 21.1%	1 8.3%	2 11.8%	1 14.3%	6 10.9%	2 NaN
Normal	14 73.7%	11 91.7%	11 64.7%	5 71.4%	25 45.5%	16 NaN
Abnormal, NCS	1 5.3%	0 0%	4 23.5%	1 14.3%	5 9.1%	1 NaN
Abnormal, CS	4 21.1%	1 8.3%	0 0%	1 14.3%	4 7.3%	2 NaN
Normal	19 100%	10 83.3%	15 88.2%	6 85.7%	34 61.8%	16 NaN
Abnormal, NCS	1 5.3%	2 16.7%	2 11.8%	1 14.3%	3 5.5%	3 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	18 94.7%	12 100%	15 88.2%	7 100%	33 60%	19 NaN
Abnormal, NCS	1 5.3%	0 0%	0 0%	0 0%	1 1.8%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	20 105.3%	12 100%	16 94.1%	7 100%	36 65.5%	19 NaN
Abnormal, NCS	0 0%	0 0%	1 5.9%	0 0%	1 1.8%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	19 100%	12 100%	15 88.2%	7 100%	34 61.8%	19 NaN
Abnormal, NCS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	19 100%	12 100%	17 100%	7 100%	36 65.5%	19 NaN
Abnormal, NCS	1 5.3%	0 0%	0 0%	0 0%	1 1.8%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	18 94.7%	12 100%	15 88.2%	7 100%	33 60%	19 NaN
Abnormal, NCS	1 5.3%	0 0%	0 0%	0 0%	1 1.8%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	19 100%	12 100%	17 100%	7 100%	36 65.5%	19 NaN
Abnormal, NCS	1 5.3%	0 0%	0 0%	0 0%	1 1.8%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	17 89.5%	12 100%	15 88.2%	7 100%	32 58.2%	19 NaN
Abnormal, NCS	2 10.5%	0 0%	0 0%	0 0%	2 3.6%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	15 78.9%	9 75%	14 82.4%	6 85.7%	29 52.7%	15 NaN
Abnormal, NCS	3 15.8%	2 16.7%	3 17.6%	1 14.3%	6 10.9%	3 NaN
Abnormal, CS	2 10.5%	1 8.3%	0 0%	0 0%	2 3.6%	1 NaN
Normal	16 84.2%	9 75%	11 64.7%	6 85.7%	27 49.1%	15 NaN
Abnormal, NCS	2 10.5%	1 8.3%	4 23.5%	1 14.3%	6 10.9%	2 NaN
Abnormal, CS	1 5.3%	2 16.7%	0 0%	0 0%	1 1.8%	2 NaN
Normal	16 84.2%	10 83.3%	15 88.2%	6 85.7%	31 56.4%	16 NaN
Abnormal, NCS	2 10.5%	0 0%	1 5.9%	1 14.3%	3 5.5%	1 NaN
Abnormal, CS	2 10.5%	2 16.7%	1 5.9%	0 0%	3 5.5%	2 NaN
Normal	15 78.9%	11 91.7%	14 82.4%	7 100%	29 52.7%	18 NaN
Abnormal, NCS	2 10.5%	0 0%	1 5.9%	0 0%	3 5.5%	0 NaN
Abnormal, CS	2 10.5%	1 8.3%	0 0%	0 0%	2 3.6%	1 NaN
Normal	11 57.9%	7 58.3%	10 58.8%	6 85.7%	21 38.2%	13 NaN
Abnormal, NCS	6 31.6%	4 33.3%	6 35.3%	1 14.3%	12 21.8%	5 NaN
Abnormal, CS	3 15.8%	1 8.3%	1 5.9%	0 0%	4 7.3%	1 NaN
Normal	12 63.2%	8 66.7%	10 58.8%	6 85.7%	22 40%	14 NaN
Abnormal, NCS	5 26.3%	3 25%	5 29.4%	0 0%	10 18.2%	3 NaN
Abnormal, CS	2 10.5%	1 8.3%	0 0%	1 14.3%	2 3.6%	2 NaN
Normal	20 105.3%	12 100%	17 100%	7 100%	37 67.3%	19 NaN
Abnormal, NCS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	19 100%	12 100%	15 88.2%	7 100%	34 61.8%	19 NaN
Abnormal, NCS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	19 100%	12 100%	17 100%	7 100%	36 65.5%	19 NaN
Abnormal, NCS	1 5.3%	0 0%	0 0%	0 0%	1 1.8%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	19 100%	12 100%	15 88.2%	7 100%	34 61.8%	19 NaN
Abnormal, NCS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN

100. Secondary Outcome

Title	Number of Participants With Change in Physical Examination From Baseline at Week 52
Description	This outcome measure presents number of participants with physical examination findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" at baseline (week 0) and week 52. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	20	12	17	7	37	19
Normal	14 73.7%	10 83.3%	12 70.6%	5 71.4%	26 47.3%	15 NaN
Abnormal, NCS	2 10.5%	1 8.3%	3 17.6%	1 14.3%	5 9.1%	2 NaN
Abnormal, CS	4 21.1%	1 8.3%	2 11.8%	1 14.3%	6 10.9%	2 NaN
Normal	13 68.4%	10 83.3%	9 52.9%	5 71.4%	22 40%	15 NaN
Abnormal, NCS	1 5.3%	0 0%	2 11.8%	0 0%	3 5.5%	0 NaN
Abnormal, CS	3 15.8%	1 8.3%	1 5.9%	0 0%	4 7.3%	1 NaN
Normal	19 100%	10 83.3%	15 88.2%	6 85.7%	34 61.8%	16 NaN
Abnormal, NCS	1 5.3%	2 16.7%	2 11.8%	1 14.3%	3 5.5%	3 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	15 78.9%	11 91.7%	12 70.6%	4 57.1%	27 49.1%	15 NaN
Abnormal, NCS	2 10.5%	0 0%	0 0%	1 14.3%	2 3.6%	1 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	20 105.3%	12 100%	16 94.1%	7 100%	36 65.5%	19 NaN
Abnormal, NCS	0 0%	0 0%	1 5.9%	0 0%	1 1.8%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	19 100%	12 100%	17 100%	7 100%	36 65.5%	19 NaN
Abnormal, NCS	1 5.3%	0 0%	0 0%	0 0%	1 1.8%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	17 89.5%	10 83.3%	12 70.6%	5 71.4%	29 52.7%	15 NaN
Abnormal, NCS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Abnormal, CS	0 0%	1 8.3%	0 0%	0 0%	0 0%	1 NaN
Normal	19 100%	12 100%	17 100%	7 100%	36 65.5%	19 NaN
Abnormal, NCS	1 5.3%	0 0%	0 0%	0 0%	1 1.8%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	16 84.2%	11 91.7%	12 70.6%	5 71.4%	28 50.9%	16 NaN
Abnormal, NCS	1 5.3%	0 0%	0 0%	0 0%	1 1.8%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	15 78.9%	9 75%	14 82.4%	6 85.7%	29 52.7%	15 NaN
Abnormal, NCS	3 15.8%	2 16.7%	3 17.6%	1 14.3%	6 10.9%	3 NaN
Abnormal, CS	2 10.5%	1 8.3%	0 0%	0 0%	2 3.6%	1 NaN
Normal	15 78.9%	10 83.3%	10 58.8%	5 71.4%	25 45.5%	15 NaN
Abnormal, NCS	1 5.3%	1 8.3%	2 11.8%	0 0%	3 5.5%	1 NaN
Abnormal, CS	1 5.3%	0 0%	0 0%	0 0%	1 1.8%	0 NaN
Normal	16 84.2%	10 83.3%	15 88.2%	6 85.7%	31 56.4%	16 NaN
Abnormal, NCS	2 10.5%	0 0%	1 5.9%	1 14.3%	3 5.5%	1 NaN
Abnormal, CS	2 10.5%	2 16.7%	1 5.9%	0 0%	3 5.5%	2 NaN
Normal	13 68.4%	10 83.3%	11 64.7%	4 57.1%	24 43.6%	14 NaN
Abnormal, NCS	1 5.3%	0 0%	0 0%	1 14.3%	1 1.8%	1 NaN
Abnormal, CS	2 10.5%	1 8.3%	1 5.9%	0 0%	3 5.5%	1 NaN
Normal	11 57.9%	7 58.3%	10 58.8%	6 85.7%	21 38.2%	13 NaN
Abnormal, NCS	6 31.6%	4 33.3%	6 35.3%	1 14.3%	12 21.8%	5 NaN
Abnormal, CS	3 15.8%	1 8.3%	1 5.9%	0 0%	4 7.3%	1 NaN
Normal	13 68.4%	8 66.7%	9 52.9%	4 57.1%	22 40%	12 NaN
Abnormal, NCS	3 15.8%	2 16.7%	3 17.6%	0 0%	6 10.9%	2 NaN
Abnormal, CS	1 5.3%	1 8.3%	0 0%	1 14.3%	1 1.8%	2 NaN
Normal	20 105.3%	12 100%	17 100%	7 100%	37 67.3%	19 NaN
Abnormal, NCS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	17 89.5%	11 91.7%	12 70.6%	5 71.4%	29 52.7%	16 NaN
Abnormal, NCS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	19 100%	12 100%	17 100%	7 100%	36 65.5%	19 NaN
Abnormal, NCS	1 5.3%	0 0%	0 0%	0 0%	1 1.8%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Normal	17 89.5%	11 91.7%	12 70.6%	5 71.4%	29 52.7%	16 NaN
Abnormal, NCS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Abnormal, CS	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN

101. Secondary Outcome

Title	Height Velocity at Week 16
Description	Height velocity was the change in height per year. The height velocity was calculated as the difference between current height and baseline divided by by time duration in days between those measurement time points and multiplied by 365 days. Height velocity calculated at Weeks 16 is presented.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	18	12	16	7	34	19
Mean (Standard Deviation) [Centimeters/year (cm/yr)]	2.113 (3.084)	2.718 (4.281)	4.190 (2.604)	6.898 (2.886)	3.090 (3.014)	4.258 (4.274)

102. Secondary Outcome

Title	Height Velocity at Week 52
Description	Height velocity was the change in height per year. The height velocity was calculated as the difference between current height and baseline divided by by time duration in days between those measurement time points and multiplied by 365 days. Height velocity calculated at Week 52 are presented.
Time Frame	week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo	Part B: Liraglutide	Part B: Placebo	Part A+B: Liraglutide	Part A+B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.	Participants received once daily subcutaneous (under the skin) injection of liraglutide for 52 weeks (open label for 16 weeks and double-blinded for 36 weeks ) in a dose escalating manner. For both part A and part B (for children with body weight ≥ 45 kilograms (kg)): dosing was initiated with liraglutide 0.6 milligrams (mg) daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For Part B children with body weight < 45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks (open label).
Measure Participants	17	11	14	6	31	17
Mean (Standard Deviation) [Centimeters/year (cm/yr)]	1.564 (1.285)	1.839 (1.658)	4.752 (2.250)	5.620 (1.690)	3.004 (2.383)	3.173 (2.466)

103. Secondary Outcome

Title	Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16
Description	C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidality, suicidal behaviour, suicidal ideation. Suicidality: emergence of any suicidal ideation or suicidal behaviour. Suicidal behaviour: when response is "yes" for any of the questions- actual attempt to suicide, engaged in non-suicidal self-injurious behaviour, interrupted attempt, aborted attempt, preparatory acts. Suicidal ideation: when response is "yes" for any of the questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. This outcome measure presents number of participants with "suicidal ideation or suicidal behaviour on C-SSRS" assessed at baseline (week 0), week 16. The questionnaire was not used in Part B due to the young age of the participants in Part B.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. This outcome measure was planned to be analyzed for Part A only.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
Measure Participants	20	12
Week 0: Suicidal ideation	1 5.3%	3 25%
Week 0: Suicidal behaviour	0 0%	0 0%
Week 16: Suicidal ideation	1 5.3%	1 8.3%
Week 16: Suicidal behaviour	0 0%	0 0%

104. Secondary Outcome

Title	Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52
Description	C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidality, suicidal behaviour, suicidal ideation. Suicidality: emergence of any suicidal ideation or suicidal behaviour. Suicidal behaviour: when response is "yes" for any of the questions- actual attempt to suicide, engaged in non-suicidal self-injurious behaviour, interrupted attempt, aborted attempt, preparatory acts. Suicidal ideation: when response is "yes" for any of the questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. This outcome measure presents number of participants with "suicidal ideation or suicidal behaviour on C-SSRS" assessed at baseline (week 0), week 52. The questionnaire was not used in Part B due to the young age of the participants in Part B.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. This outcome measure was planned to be analyzed for Part A only.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
Measure Participants	20	12
Week 0: Suicidal ideation	1 5.3%	3 25%
Week 0: Suicidal behaviour	0 0%	0 0%
Week 52: Suicidal ideation	1 5.3%	0 0%
Week 52: Suicidal behaviour	0 0%	0 0%

105. Secondary Outcome

Title	Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 16
Description	Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 16. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. The questionnaire was not used in Part B due to the young age of the participants in Part B.
Time Frame	Week 0, week 16

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. This outcome measure was planned to be analyzed for Part A only.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
Measure Participants	19	12
Mean (Standard Deviation) [Score on a scale]	-2 (4)	1 (5)

106. Secondary Outcome

Title	Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 52
Description	Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 52. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. The questionnaire was not used in Part B due to the young age of the participants in Part B.
Time Frame	Week 0, week 52

Outcome Measure Data

Analysis Population Description

SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. This outcome measure was planned to be analyzed for Part A only.

Arm/Group Title	Part A: Liraglutide	Part A: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).	Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
Measure Participants	18	11
Mean (Standard Deviation) [Score on a scale]	-2 (3)	0 (3)

Adverse Events

Time Frame	From week 0 to week 54 Results are based on SAS which included all participants exposed to at least one dose of trial product. All AEs reported here are TEAEs. TEAE is as an event that had onset date during on-treatment period.
Adverse Event Reporting Description	On-treatment period: included AEs with onset date on or after first day of trial product administration; any of following dates, whichever came first: a) 14 days after last day on trial product, or b) Follow-up visit (week54) for participants with trial product discontinuation or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Arm/Group Title	Part A: Liraglutide		Part B: Liraglutide		Part A: Placebo		Part B: Placebo
Arm/Group Description	Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52).		Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight <45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52).		Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.		Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks.
All Cause Mortality
	Part A: Liraglutide		Part B: Liraglutide		Part A: Placebo		Part B: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/17 (0%)		0/12 (0%)		0/7 (0%)
Serious Adverse Events
	Part A: Liraglutide		Part B: Liraglutide		Part A: Placebo		Part B: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		2/17 (11.8%)		0/12 (0%)		1/7 (14.3%)
General disorders
Hyperthermia	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Hepatobiliary disorders
Cholelithiasis	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Infections and infestations
Staphylococcal infection	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain	0/20 (0%)	0	0/17 (0%)	0	0/12 (0%)	0	1/7 (14.3%)	1
Surgical and medical procedures
Arthrodesis	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Spinal operation	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Other (Not Including Serious) Adverse Events
	Part A: Liraglutide		Part B: Liraglutide		Part A: Placebo		Part B: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/20 (80%)		17/17 (100%)		10/12 (83.3%)		4/7 (57.1%)
Ear and labyrinth disorders
Ear pain	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Vertigo	0/20 (0%)	0	0/17 (0%)	0	1/12 (8.3%)	1	0/7 (0%)	0
Endocrine disorders
Hypothyroidism	0/20 (0%)	0	0/17 (0%)	0	1/12 (8.3%)	1	0/7 (0%)	0
Immune-mediated thyroiditis	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Precocious puberty	0/20 (0%)	0	2/17 (11.8%)	2	0/12 (0%)	0	0/7 (0%)	0
Gastrointestinal disorders
Abdominal discomfort	0/20 (0%)	0	1/17 (5.9%)	3	0/12 (0%)	0	0/7 (0%)	0
Abdominal pain	6/20 (30%)	8	3/17 (17.6%)	12	3/12 (25%)	3	0/7 (0%)	0
Abdominal pain upper	1/20 (5%)	1	3/17 (17.6%)	7	0/12 (0%)	0	0/7 (0%)	0
Abdominal rigidity	0/20 (0%)	0	0/17 (0%)	0	1/12 (8.3%)	1	0/7 (0%)	0
Constipation	3/20 (15%)	4	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Dental caries	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Diarrhoea	10/20 (50%)	30	7/17 (41.2%)	62	2/12 (16.7%)	4	0/7 (0%)	0
Flatulence	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Gastrooesophageal reflux disease	2/20 (10%)	2	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Nausea	1/20 (5%)	2	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Overflow diarrhoea	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Vomiting	2/20 (10%)	3	3/17 (17.6%)	4	0/12 (0%)	0	0/7 (0%)	0
General disorders
Asthenia	0/20 (0%)	0	1/17 (5.9%)	2	0/12 (0%)	0	0/7 (0%)	0
Chest pain	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Fatigue	2/20 (10%)	2	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Injection site bruising	1/20 (5%)	1	1/17 (5.9%)	1	1/12 (8.3%)	1	0/7 (0%)	0
Injection site haematoma	1/20 (5%)	1	2/17 (11.8%)	3	1/12 (8.3%)	1	0/7 (0%)	0
Injection site haemorrhage	1/20 (5%)	2	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Injection site nodule	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Malaise	1/20 (5%)	1	0/17 (0%)	0	2/12 (16.7%)	2	0/7 (0%)	0
Peripheral swelling	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Pyrexia	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Hepatobiliary disorders
Hepatocellular injury	0/20 (0%)	0	0/17 (0%)	0	1/12 (8.3%)	1	0/7 (0%)	0
Immune system disorders
Seasonal allergy	1/20 (5%)	1	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Infections and infestations
Acarodermatitis	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Bronchitis	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Conjunctivitis	0/20 (0%)	0	1/17 (5.9%)	3	0/12 (0%)	0	0/7 (0%)	0
Ear infection viral	0/20 (0%)	0	1/17 (5.9%)	3	1/12 (8.3%)	1	0/7 (0%)	0
Fungal infection	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Gastroenteritis	2/20 (10%)	2	2/17 (11.8%)	4	0/12 (0%)	0	0/7 (0%)	0
Gastrointestinal viral infection	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Impetigo	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Influenza	2/20 (10%)	4	2/17 (11.8%)	2	1/12 (8.3%)	2	2/7 (28.6%)	3
Lower respiratory tract infection	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Nasopharyngitis	3/20 (15%)	3	2/17 (11.8%)	5	1/12 (8.3%)	1	0/7 (0%)	0
Oral herpes	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Otitis media	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Pharyngitis	0/20 (0%)	0	1/17 (5.9%)	1	1/12 (8.3%)	1	0/7 (0%)	0
Respiratory tract infection viral	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Rhinitis	2/20 (10%)	2	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Sinusitis	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Skin infection	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Tinea versicolour	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Tonsillitis	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Upper respiratory tract infection	1/20 (5%)	1	2/17 (11.8%)	2	1/12 (8.3%)	1	1/7 (14.3%)	1
Urinary tract infection	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Viral infection	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Viral upper respiratory tract infection	1/20 (5%)	2	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Injury, poisoning and procedural complications
Abdominal injury	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Anaemia postoperative	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Arthropod bite	2/20 (10%)	2	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Fall	1/20 (5%)	2	2/17 (11.8%)	2	0/12 (0%)	0	0/7 (0%)	0
Forearm fracture	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Hip fracture	0/20 (0%)	0	0/17 (0%)	0	1/12 (8.3%)	1	0/7 (0%)	0
Ligament sprain	0/20 (0%)	0	0/17 (0%)	0	1/12 (8.3%)	1	0/7 (0%)	0
Limb injury	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Road traffic accident	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Skin abrasion	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Soft tissue injury	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Upper limb fracture	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Investigations
Amylase increased	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Blood calcitonin increased	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Blood creatine phosphokinase increased	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Blood insulin increased	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Blood thyroid stimulating hormone increased	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
C-reactive protein increased	1/20 (5%)	1	0/17 (0%)	0	1/12 (8.3%)	1	0/7 (0%)	0
Glycosylated haemoglobin increased	0/20 (0%)	0	0/17 (0%)	0	1/12 (8.3%)	1	0/7 (0%)	0
Insulin-like growth factor decreased	0/20 (0%)	0	0/17 (0%)	0	1/12 (8.3%)	1	0/7 (0%)	0
Low density lipoprotein increased	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Thyroxine free decreased	2/20 (10%)	3	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Weight increased	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Metabolism and nutrition disorders
Hypercholesterolaemia	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Hyperlipidaemia	0/20 (0%)	0	0/17 (0%)	0	1/12 (8.3%)	1	0/7 (0%)	0
Hypernatraemia	0/20 (0%)	0	0/17 (0%)	0	1/12 (8.3%)	1	0/7 (0%)	0
Insulin resistance	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Vitamin D deficiency	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	1/20 (5%)	1	0/17 (0%)	0	1/12 (8.3%)	1	0/7 (0%)	0
Knee deformity	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Pain in extremity	2/20 (10%)	2	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Nervous system disorders
Dizziness	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Headache	2/20 (10%)	8	2/17 (11.8%)	3	3/12 (25%)	6	0/7 (0%)	0
Paraesthesia	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Psychiatric disorders
Aggression	2/20 (10%)	2	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Anxiety	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Behaviour disorder	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Depression	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Hallucination, auditory	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Insomnia	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Sleep disorder	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Tic	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Renal and urinary disorders
Dysuria	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Reproductive system and breast disorders
Amenorrhoea	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Cough	2/20 (10%)	2	1/17 (5.9%)	1	1/12 (8.3%)	1	0/7 (0%)	0
Oropharyngeal pain	2/20 (10%)	3	2/17 (11.8%)	2	0/12 (0%)	0	1/7 (14.3%)	1
Sleep apnoea syndrome	0/20 (0%)	0	0/17 (0%)	0	0/12 (0%)	0	1/7 (14.3%)	1
Skin and subcutaneous tissue disorders
Alopecia	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Dermatitis allergic	0/20 (0%)	0	1/17 (5.9%)	2	0/12 (0%)	0	0/7 (0%)	0
Ecchymosis	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Rash	0/20 (0%)	0	0/17 (0%)	0	0/12 (0%)	0	1/7 (14.3%)	1
Skin mass	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/7 (0%)	0
Surgical and medical procedures
Ear tube insertion	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0
Pain prophylaxis	0/20 (0%)	0	0/17 (0%)	0	1/12 (8.3%)	1	0/7 (0%)	0
Tooth extraction	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/7 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.