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)
56
32
2
60.4
1.8
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
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)

More Information

Additional Information:

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:

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