Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02918279
• Collaborator: (none)
• Enrollment: 251
• Locations: 33
• Arms: 2
• Actual Duration (Months): 34.3
• Patients Per Site: 7.6
• Patients Per Site Per Month: 0.2

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 pubertal adolescent subjects with obesity.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 251 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity. 56-week, Double-blind, Randomised, Parallel-group, Placebo-controlled Multi-national Trial Followed by a 26-week Period Off Study-drug
• Actual Study Start Date: Sep 29, 2016
• Actual Primary Completion Date: Feb 14, 2019
• Actual Study Completion Date: Aug 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liraglutide	Drug: Liraglutide; Administered once daily subcutaneously (s.c., under the skin)
Placebo Comparator: Placebo	Drug: Placebo; Administered once daily subcutaneously (s.c., under the skin)

Outcome Measures

Primary Outcome Measures

1. Change in BMI SDS (Week 0, Week 56) [Week 0, week 56]

   Change from baseline (week 0) in BMI SDS was evaluated at week 56. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the week 0-56 trial period and participants who prematurely discontinued the trial product but attended the follow-up visit at 56.

Secondary Outcome Measures

1. Percent of Subjects Achieving ≥5% Reduction in Baseline BMI [Weeks 30, 56 and 82]

   Participants achieving more than or equal to 5% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.

2. Percent of Subjects Achieving ≥10% Reduction in Baseline BMI [Weeks 30, 56 and 82]

   Participants achieving more than or equal to 10% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.

3. Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82)) [(Week 0, week 30); (Week 0, week 82); (Week 56, week 82)]

   Change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 82, and from week 56 to week 82. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the trial period, week 0-30 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30 or 82, respectively.

4. Change in BMI [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

   Change in BMI was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.

5. Change in Body Weight (kg) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

   Change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.

6. Change in Body Weight (%) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

   Relative change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.

7. Change in Body Weight (lb) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

   Body weight was not analysed in pounds (lb). It was analysed for standard unit, 'kg' only.

8. Change in Waist Circumference [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

   Change in waist circumference was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

9. Change in Waist-to-hip Circumference Ratio [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

   Change in waist-to-hip circumference ratio was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

10. Change in hsCRP [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in high sensitivity C reactive protein (hsCRP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

11. Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in total cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

12. Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in low density lipoprotein (LDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

13. Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in high density lipoprotein (HDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

14. Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in non-HDL cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

15. Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in very low density lipoprotein (VLDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

16. Change in Fasting Lipid: Triglycerides (Ratio to Baseline) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in triglycerides from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

17. Change in Fasting Lipid: FFA (Ratio to Baseline) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in free fatty acids (FFA) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

18. Change in Systolic and Diastolic Blood Pressure [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

19. Change in HbA1c [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

20. Change in FPG [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in fasting plasma glucose (FPG) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed treatment for the corresponding treatment period (week 0-30, week 0-56 or week 0-82).

21. Change in Fasting Insulin (Ratio to Baseline) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in fasting insulin from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

22. Change in Fasting C-peptide (Ratio to Baseline) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in fasting C-peptide from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

23. Change in Glycaemic Category [Week -2, week 30, week 56 and week 82]

    Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes (T2DM)" at baseline (weeks -2), and weeks 30, 56 and 82 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 (T2DM): FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

24. Change in HOMA-B (Ratio to Baseline) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in homeostasis model assessment of beta-cell function (HOMA-B) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5). Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

25. Change in HOMA-IR (Ratio to Baseline) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in homeostasis model assessment of insulin resistance (HOMA-IR) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting insulin [mU/L] x FPG [mmol/L]/ 22.5. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

26. Change in IWQOL-Kids [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in Impact of Weight on Quality of Life-Kids (IWQOL-Kids) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. The IWQOL-Kids is a 27-item measure of weight-related quality of life. There are four domain scores (Physical Comfort, Body Esteem, Social Life and Family Life) and a total score. Scores for all domains and total score range from 0-100, with higher scores representing better health-related quality of life. IWQOL-kids data at week 82 was not collected, thus could not be evaluated. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

27. Change in BMI SDS (%) [(Week 0, week 30); (Week 0, week 56)]

    Relative change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 56. Results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.

28. Change in Nutritional Compliance [Week 0, week 30 and week 56]

    This outcome measure presents "nutritional compliance results" recorded at baseline (week 0), week 30 and week 56. Nutritional compliance was recorded on a 0 to 10 numeric rating scale, with higher scores representing better compliance. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.

29. Number of Treatment Emergent Adverse Events [Week 0-56 + 14 days]

    A treatment emergent adverse event (TEAE) was defined as an event that occurred in the "on-treatment" period. 'On-treatment' period: Events with onset date between the first day of trial product administration and any of the following date, whichever came first: 1) 14 days after the last day on trial product, or 2) follow-up visit (week 58) for participants who discontinued trial product, or 3) last study visit (participants withdrawn without follow-up visit).

30. Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) [Week 0-56 + 14 days]

    A hypoglycaemic episode was 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 episodes were recorded as per international society for pediatric and adolescent diabetes (ISPAD) definition. And the following presented hypoglycaemia episodes were recorded as per American Diabetes Association (ADA) definition: asymptomatic hypoglycaemia, documented symptomatic hypoglycaemia, pseudo-hypoglycaemia and probable symptomatic hypoglycaemia.

31. Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification) [Week 0-56 + 14 days]

    Severe hypoglycaemia episodes were recorded as per the ISPAD definition. And the following presented hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. 4) Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. 5) BG-confirmed: An episode that is BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 6) Severe or BG-confirmed: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.

32. Occurrence of Anti-liraglutide Antibodies [Weeks 0, 30, 56, 58, 70 and 82]

    This outcome measure is only applicable for the liraglutide 3.0 mg treatment arm. Number of participants who measured with anti-liraglutide binding antibodies at weeks 0, 30, 56, 58, 70 and 82 are presented.

33. Change in Pulse [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in pulse was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

34. Change in ECG [Week -14, week 30, week 56 and week 82]

    This outcome measure presents number of subjects with electrocardiogram findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" recorded at baseline (week -14), week 30 and week 56. These findings were categorised by the investigator. Electrocardiogram (ECG) data at week 82 was not collected, thus could not be evaluated. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.

35. Change in Haematology: Haemoglobin [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in haemoglobin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

36. Change in Haematology: Haematocrit [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in haematocrit was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

37. Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in haematological parameters, "thrombocytes, leucocytes, eosinophils, neutrophils, basophils, lymphocytes and monocytes" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

38. Change in Haematology: Erythrocytes [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in erythrocytes was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

39. Change in Biochemistry: Creatinine and Bilirubin (Total) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in creatinine and bilirubin (total) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

40. Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in biochemistry parameters, "creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

41. Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in biochemistry parameters, "urea (blood urea nitrogen [BUN]), sodium, potassium, calcium total and calcium (Ca) albumin-corrected" was evaluated from baseline (week [Wk] 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

42. Change in Biochemistry: Albumin [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in albumin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

43. Change in Biochemistry: CEA [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in carcinoembryonic antigen (CEA) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

44. Change in Hormone Level: Calcitonin [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in calcitonin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

45. Change in Hormone Level: TSH and Prolactin [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in hormone levels, "thyroid stimulating hormone (TSH) and prolactin" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

46. Change in Hormone Level: Free T4 and ACTH [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in hormone levels, "thyroxine (T4) and adrenocorticotropic hormone (ACTH)" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

47. Change in Hormone Level: IGF-1 and Cortisol [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in hormone levels, "insulin-like growth factor-1 (IGF-1) and cortisol" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

48. Change in Hormone Level: DHEAS [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in dehydroepiandrosterone sulfate (DHEAS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

49. Change in Hormone Level: LH and FSH [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in hormone levels, "luteinising hormone (LH) and follicle stimulating hormone (FSH)" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

50. Change in Hormone Level: Estradiol (Females) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in estradiol (only for female) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

51. Change in Hormone Level: Testosterone (Males) [Week 0, week 30, week 56 and week 82]

    This outcome measure presents "testosterone (only for males) results" for baseline (week 0), week 30, week 56 and week 82. ADVIA Centaur Testosterone (TSTO) assay was used for the evaluation of testosterone hormone. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

52. Change in NTX1 [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in type I collagen N-telopeptide (NTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are presented in "nmol bone collagen equivalents (BCE)/L". Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

53. Change in CTX1 [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in type I collagen C-telopeptide (CTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

54. Change in P1NP [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in procollagen 1 N-terminal propeptide (P1NP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

55. Change in Alkaline Phosphatase (Bone) [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in alkaline phosphatase (bone specific) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

56. Change in Pubertal Status [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    This outcome measure presents "pubertal status results" which is based on Tanner staging (Tanner stage 2-5), recorded at baseline (week 0), week 30, week 56 and week 82. Results are presented for the following categories: 1) For female: breast development and pubic hair development (by Tanner staging). 2) For male: penis development and pubic hair development (by Tanner staging). Each category shows number of participants in stages 2 to 5, where stage 2 represents "early pubertal development" and stage 5 represents "pubertal development equivalent to that of an adult". Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

57. Change in Physical Examination [Week 0, week 30, week 56 and week 82]

    This outcome measure presents number of subjects with physical examination findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" at baseline (week 0), week 30, week 56 and week 82. 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". Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

58. Change in Height SDS [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in height standard deviation score (SDS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.

59. Change in C-SSRS [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    This outcome measure presents number of subjects with "suicidal ideation or suicidal behaviour on the Columbia Suicidality Severity Rating Scale (C-SSRS)" assessed at baseline (week 0), week 30, week 56 and week 82. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

60. Change in PHQ-9 [(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)]

    Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. 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. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 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

• Male or female, age 12 to less than 18 years at the time of signing informed consent and less than 18 years at date of randomisation

• BMI corresponding to equal to or above 30 kg/m^2 for adults by international cut-off points 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 V2 (below 5 kg self-reported weight change)

• History of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject's medical record

Exclusion Criteria:

• Pre-pubertal subjects (Tanner stage 1) at screening V2

• Type 1 diabetes mellitus (T1DM)

• Family or personal history of multiple endocrine neoplasia type 2 (MEN2)

• Medullary thyroid carcinoma (MTC)

• History of pancreatitis (acute or chronic)

• Subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes)

• Treatment with medications within 90 days before screening V2 that, based on the investigator's judgement, may cause significant weight change. This should also include treatment with any of the following medications: pramlintide, orlistat, zonisamide, topiramate, lorcaserin, phenteremine, bupropion, naltrexone, glucagon-like peptide-1 (GLP-1) receptor agonists, or metformin (used as treatment for obesity)

• Anti-diabetic treatment other than metformin

• History of major depressive disorder within 2 years before screening V2

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Meridian	Idaho	United States	83646
2	Novo Nordisk Investigational Site	Baton Rouge	Louisiana	United States	70808-4124
3	Novo Nordisk Investigational Site	Baltimore	Maryland	United States	21229
4	Novo Nordisk Investigational Site	Minneapolis	Minnesota	United States	55455
5	Novo Nordisk Investigational Site	Buffalo	New York	United States	14222
6	Novo Nordisk Investigational Site	Columbus	Ohio	United States	43213
7	Novo Nordisk Investigational Site	Dayton	Ohio	United States	45406
8	Novo Nordisk Investigational Site	Dayton	Ohio	United States	45419
9	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania	United States	15224
10	Novo Nordisk Investigational Site	Charleston	South Carolina	United States	29425
11	Novo Nordisk Investigational Site	Goose Creek	South Carolina	United States	29445
12	Novo Nordisk Investigational Site	Greenville	South Carolina	United States	29615
13	Novo Nordisk Investigational Site	Memphis	Tennessee	United States	38119
14	Novo Nordisk Investigational Site	Brussels		Belgium	1090
15	Novo Nordisk Investigational Site	Brussels		Belgium	1200
16	Novo Nordisk Investigational Site	Edegem		Belgium	2650
17	Novo Nordisk Investigational Site	Hasselt		Belgium	3500
18	Novo Nordisk Investigational Site	Leuven		Belgium	3000
19	Novo Nordisk Investigational Site	Namur		Belgium	5000
20	Novo Nordisk Investigational Site	Ciudad Madero	Tamaulipas	Mexico	89440
21	Novo Nordisk Investigational Site	Puebla		Mexico	72190
22	Novo Nordisk Investigational Site	Moscow		Russian Federation	125373
23	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630048
24	Novo Nordisk Investigational Site	Rostov-on-Don		Russian Federation	344013
25	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	191144
26	Novo Nordisk Investigational Site	Samara		Russian Federation	443079
27	Novo Nordisk Investigational Site	Stavropol		Russian Federation	355035
28	Novo Nordisk Investigational Site	Tomsk		Russian Federation	634050
29	Novo Nordisk Investigational Site	Ufa		Russian Federation	450106
30	Novo Nordisk Investigational Site	Göteborg		Sweden	416 85
31	Novo Nordisk Investigational Site	Huddinge		Sweden	141 57
32	Novo Nordisk Investigational Site	Malmö		Sweden	205 02
33	Novo Nordisk Investigational Site	Uppsala		Sweden	751 85

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR), Novo Nordisk A/S

Study Documents (Full-Text)

• Study Protocol - Dec 11, 2019
• Statistical Analysis Plan - Dec 11, 2019

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02918279
• Other Study ID Numbers: NN8022-4180; 2014-004353-14; U1111-1162-7101
• First Posted: Sep 28, 2016
• Last Update Posted: Apr 27, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Obesity; Nutrition Disorders; Liraglutide

Study Results

Participant Flow

Recruitment Details	This trial was conducted at 32 sites in 5 countries: Belgium (6 sites), Sweden (4 sites), Russia (8 sites), Mexico (2 sites) and the United States of America (USA - 12 sites). Additionally, 1 site in the USA was approved by the independent review board, but did not randomise any participant.
Pre-assignment Detail	This trial consisted of a 12-week run-in period, during which participants received counselling on healthy nutrition and physical activity. Completed numbers include participants who completed the trial without prematurely discontinuing the trial product and participants who discontinued the trial product but came for the week 82 follow-up visit.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by subcutaneous (s.c.; under the skin) injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Period Title: Overall Study
STARTED	125	126
Full Analysis Set	125	126
Safety Analysis Set	125	126
COMPLETED	112	103
NOT COMPLETED	13	23

Baseline Characteristics

Arm/Group Title	Liraglutide 3.0 mg	Placebo	Total
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Total of all reporting groups
Overall Participants	125	126	251
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	14.6 (1.6)	14.5 (1.6)	14.5 (1.6)
Sex: Female, Male (Count of Participants)
Female	71 56.8%	78 61.9%	149 59.4%
Male	54 43.2%	48 38.1%	102 40.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	32 25.6%	24 19%	56 22.3%
Not Hispanic or Latino	93 74.4%	102 81%	195 77.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.8%	1 0.4%
Asian	2 1.6%	0 0%	2 0.8%
Black or African American	14 11.2%	6 4.8%	20 8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
White	105 84%	115 91.3%	220 87.6%
Other	4 3.2%	4 3.2%	8 3.2%

Outcome Measures

1. Primary Outcome

Title	Change in BMI SDS (Week 0, Week 56)
Description	Change from baseline (week 0) in BMI SDS was evaluated at week 56. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the week 0-56 trial period and participants who prematurely discontinued the trial product but attended the follow-up visit at 56.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description

Results are based on the full analysis set (FAS) which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). "Overall Number of Participants Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	113	105
Mean (Standard Deviation) [SDS score]	-0.25 (0.51)	-0.02 (0.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Liraglutide 3.0 mg, Placebo
	Comments	Analysis of in-trial data with missing observations was imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Responses at week 56 were analysed using an analysis of covariance model with treatment, sex, region, baseline glycaemic category, stratification factor for Tanner stage and interaction between baseline glycaemic category and stratification factor for Tanner stage as fixed effects, baseline BMI SDS, age as covariates.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0022
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95%; -0.37 to -0.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	Liraglutide 3.0 mg - Placebo

2. Secondary Outcome

Title	Percent of Subjects Achieving ≥5% Reduction in Baseline BMI
Description	Participants achieving more than or equal to 5% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time Frame	Weeks 30, 56 and 82

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Week 30 (Yes)	46.2 37%	14.7 11.7%
Week 30 (No)	53.8 43%	85.3 67.7%
Week 56 (Yes)	45.1 36.1%	19.0 15.1%
Week 56 (No)	54.9 43.9%	81.0 64.3%
Week 82 (Yes)	29.5 23.6%	18.6 14.8%
Week 82 (No)	70.5 56.4%	81.4 64.6%

3. Secondary Outcome

Title	Percent of Subjects Achieving ≥10% Reduction in Baseline BMI
Description	Participants achieving more than or equal to 10% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time Frame	Weeks 30, 56 and 82

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Week 30 (Yes)	24.4 19.5%	5.2 4.1%
Week 30 (No)	75.6 60.5%	94.8 75.2%
Week 56 (Yes)	29.2 23.4%	8.6 6.8%
Week 56 (No)	70.8 56.6%	91.4 72.5%
Week 82 (Yes)	18.8 15%	10.8 8.6%
Week 82 (No)	81.3 65%	89.2 70.8%

4. Secondary Outcome

Title	Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))
Description	Change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 82, and from week 56 to week 82. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the trial period, week 0-30 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30 or 82, respectively.
Time Frame	(Week 0, week 30); (Week 0, week 82); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-0.26 (0.34)	-0.04 (0.33)
Change from week 0 to week 82	-0.06 (0.53)	0.07 (0.66)
Change from week 56 to week 82	0.22 (0.28)	0.08 (0.27)

5. Secondary Outcome

Title	Change in BMI
Description	Change in BMI was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-1.8 (2.1)	-0.2 (2.2)
Change from week 0 to week 56	-1.6 (3.1)	0.1 (3.4)
Change from week 56 to week 82	1.5 (1.7)	0.7 (1.7)

6. Secondary Outcome

Title	Change in Body Weight (kg)
Description	Change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-3.9 (6.1)	0.4 (6.6)
Change from week 0 to week 56	-2.7 (9.1)	2.1 (10.2)
Change from week 56 to week 82	4.7 (4.6)	2.4 (4.9)

7. Secondary Outcome

Title	Change in Body Weight (%)
Description	Relative change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-4.3 (6.5)	0.4 (6.2)
Change from week 0 to week 56	-3.2 (9.4)	2.2 (9.5)
Change from week 56 to week 82	5.3 (5.7)	2.3 (4.9)

8. Secondary Outcome

Title	Change in Body Weight (lb)
Description	Body weight was not analysed in pounds (lb). It was analysed for standard unit, 'kg' only.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Body weight was not analysed in pounds (lb).

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	0	0

9. Secondary Outcome

Title	Change in Waist Circumference
Description	Change in waist circumference was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-4.63 (6.24)	-2.01 (5.94)
Change from week 0 to week 56	-5.12 (7.87)	-1.51 (8.20)
Change from week 56 to week 82	3.58 (4.30)	1.24 (5.60)

10. Secondary Outcome

Title	Change in Waist-to-hip Circumference Ratio
Description	Change in waist-to-hip circumference ratio was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-0.015 (0.042)	-0.018 (0.042)
Change from week 0 to week 56	-0.022 (0.053)	-0.023 (0.051)
Change from week 56 to week 82	0.010 (0.031)	0.003 (0.049)

11. Secondary Outcome

Title	Change in hsCRP
Description	Change in high sensitivity C reactive protein (hsCRP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the safety analysis set (SAS) which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-0.22 (5.04)	-0.56 (4.68)
Change from week 0 to week 56	-0.25 (4.54)	-0.14 (3.44)
Change from week 56 to week 82	1.51 (7.61)	1.00 (4.22)

12. Secondary Outcome

Title	Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline)
Description	Change in total cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	1.00 (12.8)	0.98 (13.0)
Change from week 0 to week 56	1.00 (14.2)	1.00 (13.0)
Change from week 56 to week 82	1.02 (14.7)	1.02 (14.9)

13. Secondary Outcome

Title	Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline)
Description	Change in low density lipoprotein (LDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	1.00 (19.8)	1.00 (26.1)
Change from week 0 to week 56	0.99 (21.8)	1.02 (23.6)
Change from week 56 to week 82	1.03 (22.5)	1.04 (20.6)

14. Secondary Outcome

Title	Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline)
Description	Change in high density lipoprotein (HDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	1.04 (15.3)	1.01 (20.5)
Change from week 0 to week 56	1.04 (17.4)	1.02 (18.9)
Change from week 56 to week 82	0.99 (15.8)	1.00 (15.2)

15. Secondary Outcome

Title	Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline)
Description	Change in non-HDL cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	0.98 (16.8)	0.97 (18.0)
Change from week 0 to week 56	0.98 (18.4)	0.99 (16.7)
Change from week 56 to week 82	1.03 (19.8)	1.02 (18.6)

16. Secondary Outcome

Title	Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline)
Description	Change in very low density lipoprotein (VLDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	0.91 (36.8)	0.90 (42.7)
Change from week 0 to week 56	0.92 (43.7)	0.93 (34.6)
Change from week 56 to week 82	1.04 (51.0)	0.97 (34.1)

17. Secondary Outcome

Title	Change in Fasting Lipid: Triglycerides (Ratio to Baseline)
Description	Change in triglycerides from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	0.91 (36.9)	0.91 (42.9)
Change from week 0 to week 56	0.92 (43.2)	0.93 (34.4)
Change from week 56 to week 82	1.04 (50.4)	0.97 (34.0)

18. Secondary Outcome

Title	Change in Fasting Lipid: FFA (Ratio to Baseline)
Description	Change in free fatty acids (FFA) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	0.96 (57.7)	0.83 (56.4)
Change from week 0 to week 56	1.00 (48.9)	0.95 (50.8)
Change from week 56 to week 82	0.99 (55.2)	0.94 (38.0)

19. Secondary Outcome

Title	Change in Systolic and Diastolic Blood Pressure
Description	Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
SBP: Change from week 0 to week 30	-2 (9)	-1 (10)
SBP: Change from week 0 to week 56	-2 (10)	1 (10)
SBP: Change from week 56 to week 82	2 (9)	1 (10)
DBP: Change from week 0 to week 30	-0 (8)	-1 (10)
DBP: Change from week 0 to week 56	1 (9)	-1 (9)
DBP: Change from week 56 to week 82	2 (8)	2 (7)

20. Secondary Outcome

Title	Change in HbA1c
Description	Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-0.1 (0.3)	-0.0 (0.3)
Change from week 0 to week 56	-0.1 (0.3)	-0.0 (0.2)
Change from week 56 to week 82	0.1 (0.2)	0.1 (0.3)

21. Secondary Outcome

Title	Change in FPG
Description	Change in fasting plasma glucose (FPG) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed treatment for the corresponding treatment period (week 0-30, week 0-56 or week 0-82).
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-0.2 (0.4)	-0.0 (0.5)
Change from week 0 to week 56	-0.1 (0.5)	-0.0 (0.6)
Change from week 56 to week 82	0.1 (0.6)	0.1 (0.5)

22. Secondary Outcome

Title	Change in Fasting Insulin (Ratio to Baseline)
Description	Change in fasting insulin from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	1.13 (70.9)	1.14 (53.7)
Change from week 0 to week 56	1.06 (69.4)	1.10 (73.8)
Change from week 56 to week 82	1.00 (60.9)	1.08 (55.2)

23. Secondary Outcome

Title	Change in Fasting C-peptide (Ratio to Baseline)
Description	Change in fasting C-peptide from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	1.12 (42.6)	1.04 (35.1)
Change from week 0 to week 56	0.98 (44.9)	0.97 (47.4)
Change from week 56 to week 82	0.92 (43.6)	0.94 (32.9)

24. Secondary Outcome

Title	Change in Glycaemic Category
Description	Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes (T2DM)" at baseline (weeks -2), and weeks 30, 56 and 82 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 (T2DM): FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	Week -2, week 30, week 56 and week 82

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Normoglycaemia	93 74.4%	93 73.8%
Pre-diabetes	31 24.8%	32 25.4%
Type 2 diabetes	1 0.8%	1 0.8%
Normoglycaemia	95 76%	86 68.3%
Pre-diabetes	19 15.2%	29 23%
Type 2 diabetes	2 1.6%	1 0.8%
Normoglycaemia	86 68.8%	75 59.5%
Pre-diabetes	17 13.6%	24 19%
Type 2 diabetes	2 1.6%	2 1.6%
Normoglycaemia	79 63.2%	65 51.6%
Pre-diabetes	20 16%	30 23.8%
Type 2 diabetes	1 0.8%	4 3.2%

25. Secondary Outcome

Title	Change in HOMA-B (Ratio to Baseline)
Description	Change in homeostasis model assessment of beta-cell function (HOMA-B) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5). Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	1.32 (70.8)	1.17 (59.5)
Change from week 0 to week 56	1.13 (67.0)	1.11 (58.0)
Change from week 56 to week 82	0.92 (65.9)	1.02 (50.2)

26. Secondary Outcome

Title	Change in HOMA-IR (Ratio to Baseline)
Description	Change in homeostasis model assessment of insulin resistance (HOMA-IR) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting insulin [mU/L] x FPG [mmol/L]/ 22.5. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	1.08 (75.2)	1.14 (55.6)
Change from week 0 to week 56	1.04 (75.3)	1.09 (80.0)
Change from week 56 to week 82	1.03 (64.2)	1.11 (60.5)

27. Secondary Outcome

Title	Change in IWQOL-Kids
Description	Change in Impact of Weight on Quality of Life-Kids (IWQOL-Kids) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. The IWQOL-Kids is a 27-item measure of weight-related quality of life. There are four domain scores (Physical Comfort, Body Esteem, Social Life and Family Life) and a total score. Scores for all domains and total score range from 0-100, with higher scores representing better health-related quality of life. IWQOL-kids data at week 82 was not collected, thus could not be evaluated. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Body Esteem: Change from week 0 to week 30	10.62 (19.88)	6.73 (26.87)
Body Esteem: Change from week 0 to week 56	13.33 (19.47)	13.24 (22.72)
Family Relation: Change from week 0 to week 30	2.53 (9.66)	-2.19 (17.53)
Family Relation: Change from week 0 to week 56	1.44 (14.31)	0.97 (5.61)
Physical Function: Change from week 0 to week 30	3.94 (15.34)	0.43 (22.02)
Physical Function: Change from week 0 to week 56	6.17 (15.44)	3.32 (16.60)
Social Life: Change from week 0 to week 30	5.32 (10.56)	1.76 (21.98)
Social Life: Change from week 0 to week 56	5.97 (19.48)	6.06 (14.04)
Total: Change from week 0 to week 30	6.16 (11.04)	2.24 (19.69)
Total: Change from week 0 to week 56	7.46 (13.70)	6.72 (11.62)

28. Secondary Outcome

Title	Change in BMI SDS (%)
Description	Relative change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 56. Results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.
Time Frame	(Week 0, week 30); (Week 0, week 56)

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-8.73 (1.05)	-1.70 (1.07)
Change from week 0 to week 56	-8.32 (1.68)	-0.68 (1.74)

29. Secondary Outcome

Title	Change in Nutritional Compliance
Description	This outcome measure presents "nutritional compliance results" recorded at baseline (week 0), week 30 and week 56. Nutritional compliance was recorded on a 0 to 10 numeric rating scale, with higher scores representing better compliance. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.
Time Frame	Week 0, week 30 and week 56

Outcome Measure Data

Analysis Population Description

Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Week 0	7.10 (1.74)	7.07 (1.69)
Week 30	6.74 (2.08)	6.51 (1.91)
Week 56	6.87 (1.87)	6.45 (1.84)

30. Secondary Outcome

Title	Number of Treatment Emergent Adverse Events
Description	A treatment emergent adverse event (TEAE) was defined as an event that occurred in the "on-treatment" period. 'On-treatment' period: Events with onset date between the first day of trial product administration and any of the following date, whichever came first: 1) 14 days after the last day on trial product, or 2) follow-up visit (week 58) for participants who discontinued trial product, or 3) last study visit (participants withdrawn without follow-up visit).
Time Frame	Week 0-56 + 14 days

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Number [Events]	777	627

31. Secondary Outcome

Title	Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification)
Description	A hypoglycaemic episode was 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 episodes were recorded as per international society for pediatric and adolescent diabetes (ISPAD) definition. And the following presented hypoglycaemia episodes were recorded as per American Diabetes Association (ADA) definition: asymptomatic hypoglycaemia, documented symptomatic hypoglycaemia, pseudo-hypoglycaemia and probable symptomatic hypoglycaemia.
Time Frame	Week 0-56 + 14 days

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Severe hypoglycaemia	0	0
Asymptomatic hypoglycaemia	12	17
Documented symptomatic hypoglycaemia	31	6
Probable symptomatic hypoglycaemia	1	2
Pseudo-hypoglycaemia	30	3
Unclassifiable	4	0

32. Secondary Outcome

Title	Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification)
Description	Severe hypoglycaemia episodes were recorded as per the ISPAD definition. And the following presented hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. 4) Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. 5) BG-confirmed: An episode that is BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 6) Severe or BG-confirmed: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.
Time Frame	Week 0-56 + 14 days

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Severe hypoglycaemia	0	0
Asymptomatic BG-confirmed hypoglycaemia	1	1
Symptomatic BG-confirmed hypoglycaemia	4	0
Unclassifiable	73	27

33. Secondary Outcome

Title	Occurrence of Anti-liraglutide Antibodies
Description	This outcome measure is only applicable for the liraglutide 3.0 mg treatment arm. Number of participants who measured with anti-liraglutide binding antibodies at weeks 0, 30, 56, 58, 70 and 82 are presented.
Time Frame	Weeks 0, 30, 56, 58, 70 and 82

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125
Weeks 0	0 0%
Weeks 30	6 4.8%
Weeks 56	5 4%
Weeks 58	11 8.8%
Weeks 70	6 4.8%
Weeks 82	2 1.6%

34. Secondary Outcome

Title	Change in Pulse
Description	Change in pulse was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	4 (12)	-1 (12)
Change from week 0 to week 56	4 (11)	-1 (12)
Change from week 56 to week 82	-3 (9)	2 (11)

35. Secondary Outcome

Title	Change in ECG
Description	This outcome measure presents number of subjects with electrocardiogram findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" recorded at baseline (week -14), week 30 and week 56. These findings were categorised by the investigator. Electrocardiogram (ECG) data at week 82 was not collected, thus could not be evaluated. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.
Time Frame	Week -14, week 30, week 56 and week 82

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Normal	102 81.6%	100 79.4%
Abnormal, NCS	23 18.4%	26 20.6%
Abnormal, CS	0 0%	0 0%
Normal	97 77.6%	95 75.4%
Abnormal, NCS	20 16%	21 16.7%
Abnormal, CS	0 0%	0 0%
Normal	83 66.4%	80 63.5%
Abnormal, NCS	21 16.8%	23 18.3%
Abnormal, CS	0 0%	0 0%
Normal
Abnormal, NCS
Abnormal, CS

36. Secondary Outcome

Title	Change in Haematology: Haemoglobin
Description	Change in haemoglobin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	0.2 (0.5)	0.0 (0.4)
Change from week 0 to week 56	0.3 (0.6)	0.1 (0.6)
Change from week 56 to week 82	-0.1 (0.6)	-0.0 (0.4)

37. Secondary Outcome

Title	Change in Haematology: Haematocrit
Description	Change in haematocrit was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	0.7 (2.3)	0.1 (2.4)
Change from week 0 to week 56	1.2 (2.7)	0.4 (2.8)
Change from week 56 to week 82	-0.4 (2.9)	-0.4 (1.9)

38. Secondary Outcome

Title	Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes
Description	Change in haematological parameters, "thrombocytes, leucocytes, eosinophils, neutrophils, basophils, lymphocytes and monocytes" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Thrombocytes: Change from week 0 to week 30	9 (37)	14 (38)
Thrombocytes: Change from week 0 to week 56	7 (46)	7 (39)
Thrombocytes: Change from week 56 to week 82	-2 (31)	3 (37)
Leucocytes: Change from week 0 to week 30	0.1 (1.6)	-0.1 (2)
Leucocytes: Change from week 0 to week 56	-0.2 (1.6)	-0.4 (1.7)
Leucocytes: Change from week 56 to week 82	0.2 (1.5)	0.0 (2.0)
Eosinophils: Change from week 0 to week 30	0.03 (0.15)	0.04 (0.29)
Eosinophils: Change from week 0 to week 56	0.01 (0.15)	0.00 (0.23)
Eosinophils: Change from week 56 to week 82	-0.01 (0.12)	0.00 (0.15)
Neutrophils: Change from week 0 to week 30	0.18 (1.33)	-0.01 (1.71)
Neutrophils: Change from week 0 to week 56	-0.01 (1.49)	-0.13 (1.50)
Neutrophils: Change from week 56 to week 82	0.21 (1.35)	-0.00 (1.71)
Basophils: Change from week 0 to week 30	0.01 (0.03)	0.01 (0.03)
Basophils: Change from week 0 to week 56	0.01 (0.03)	0.02 (0.03)
Basophils: Change from week 56 to week 82	0.00 (0.03)	0.00 (0.03)
Lymphocytes: Change from week 0 to week 30	-0.18 (0.69)	-0.14 (0.62)
Lymphocytes: Change from week 0 to week 56	-0.28 (0.59)	-0.27 (0.72)
Lymphocytes: Change from week 56 to week 82	-0.03 (0.48)	-0.00 (0.61)
Monocytes: Change from week 0 to week 30	0.04 (0.16)	0.00 (0.18)
Monocytes: Change from week 0 to week 56	0.06 (0.13)	0.01 (0.17)
Monocytes: Change from week 56 to week 82	-0.00 (0.15)	0.04 (0.18)

39. Secondary Outcome

Title	Change in Haematology: Erythrocytes
Description	Change in erythrocytes was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	0.0 (0.2)	-0.0 (0.3)
Change from week 0 to week 56	-0.0 (0.3)	-0.1 (0.3)
Change from week 56 to week 82	-0.1 (0.3)	0.0 (0.2)

40. Secondary Outcome

Title	Change in Biochemistry: Creatinine and Bilirubin (Total)
Description	Change in creatinine and bilirubin (total) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Creatinine: Change from week 0 to week 30	1 (7)	0 (8)
Creatinine: Change from week 0 to week 56	2 (7)	4 (9)
Creatinine: Change from week 56 to week 82	2 (8)	1 (10)
Bilirubin (total): Change from week 0 to week 30	1 (4)	1 (5)
Bilirubin (total): Change from week 0 to week 56	1 (4)	1 (5)
Bilirubin (total): Change from week 56 to week 82	0 (5)	-0 (4)

41. Secondary Outcome

Title	Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP
Description	Change in biochemistry parameters, "creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Creatinine kinase: Change from week 0 to week 30	13 (251)	0 (225)
Creatinine kinase: Change from week 0 to week 56	32 (228)	0 (111)
Creatinine kinase: Change from week 56 to week 82	28 (321)	4 (114)
Amylase: Change from week 0 to week 30	4 (12)	3 (16)
Amylase: Change from week 0 to week 56	2 (10)	-0 (9)
Amylase: Change from week 56 to week 82	-1 (8)	1 (11)
Lipase: Change from week 0 to week 30	6 (13)	1 (19)
Lipase: Change from week 0 to week 56	3 (13)	-2 (5)
Lipase: Change from week 56 to week 82	-4 (9)	-0 (5)
ALT: Change from week 0 to week 30	-2 (15)	-1 (15)
ALT: Change from week 0 to week 56	-2 (16)	-0 (23)
ALT: Change from week 56 to week 82	1 (12)	2 (20)
AST: Change from week 0 to week 30	-1 (8)	-1 (11)
AST: Change from week 0 to week 56	-1 (8)	-1 (11)
AST: Change from week 56 to week 82	1 (12)	1 (11)
ALP: Change from week 0 to week 30	-16 (25)	-8 (66)
ALP: Change from week 0 to week 56	-23 (36)	-19 (53)
ALP: Change from week 56 to week 82	-2 (22)	-10 (24)

42. Secondary Outcome

Title	Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected
Description	Change in biochemistry parameters, "urea (blood urea nitrogen [BUN]), sodium, potassium, calcium total and calcium (Ca) albumin-corrected" was evaluated from baseline (week [Wk] 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Urea (BUN): Change from week 0 to week 30	-0.06 (1.07)	0.00 (1.14)
Urea (BUN): Change from week 0 to week 56	-0.26 (1.01)	-0.05 (1.19)
Urea (BUN): Change from week 56 to week 82	0.23 (1.11)	0.00 (1.07)
Sodium: Change from week 0 to week 30	0 (2)	0 (2)
Sodium: Change from week 0 to week 56	0 (2)	0 (3)
Sodium: Change from week 56 to week 82	-1 (3)	-1 (3)
Potassium: Change from week 0 to week 30	-0.0 (0.4)	0.0 (0.3)
Potassium: Change from week 0 to week 56	-0.1 (0.4)	-0.0 (0.3)
Potassium: Change from week 56 to week 82	0.0 (0.3)	-0.0 (0.4)
Calcium total: Change from week 0 to week 30	-0.01 (0.09)	-0.03 (0.09)
Calcium total: Change from week 0 to week 56	-0.04 (0.10)	-0.04 (0.09)
Calcium total: Change from week 56 to week 82	-0.00 (0.09)	-0.01 (0.09)
Ca albumin-corrected:Change from week 0 to week 30	-0.04 (0.09)	-0.03 (0.09)
Ca albumin-corrected:Change from week 0 to week 56	-0.07 (0.10)	-0.07 (0.08)
Ca albumin-corrected: Change from Wk 56 to Wk 82	0.01 (0.07)	-0.00 (0.09)

43. Secondary Outcome

Title	Change in Biochemistry: Albumin
Description	Change in albumin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	0.1 (0.2)	0.0 (0.3)
Change from week 0 to week 56	0.1 (0.3)	0.1 (0.3)
Change from week 56 to week 82	-0.0 (0.2)	-0.0 (0.3)

44. Secondary Outcome

Title	Change in Biochemistry: CEA
Description	Change in carcinoembryonic antigen (CEA) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-0.0 (0.3)	-0.1 (0.6)
Change from week 0 to week 56	0.0 (0.4)	-0.0 (0.6)
Change from week 56 to week 82	0.0 (0.4)	0.0 (0.3)

45. Secondary Outcome

Title	Change in Hormone Level: Calcitonin
Description	Change in calcitonin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	0.1 (0.8)	0.1 (0.7)
Change from week 0 to week 56	0.0 (0.7)	-0.0 (0.8)
Change from week 56 to week 82	-0.1 (0.6)	0.2 (1.5)

46. Secondary Outcome

Title	Change in Hormone Level: TSH and Prolactin
Description	Change in hormone levels, "thyroid stimulating hormone (TSH) and prolactin" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
TSH: Change from week 0 to week 30	-0.35 (1.37)	-0.08 (1.17)
TSH: Change from week 0 to week 56	-0.42 (1.36)	-0.14 (1.28)
TSH: Change from week 56 to week 82	0.38 (1.91)	0.13 (1.57)
Prolactin: Change from week 0 to week 30	23 (165)	-47 (452)
Prolactin: Change from week 0 to week 56	63 (312)	-63 (684)
Prolactin: Change from week 56 to week 82	-29 (396)	13 (98)

47. Secondary Outcome

Title	Change in Hormone Level: Free T4 and ACTH
Description	Change in hormone levels, "thyroxine (T4) and adrenocorticotropic hormone (ACTH)" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
T4: Change from week 0 to week 30	0.6 (1.9)	0.8 (2.1)
T4: Change from week 0 to week 56	0.3 (1.8)	0.6 (2.1)
T4: Change from week 56 to week 82	0.0 (1.6)	0.2 (2.3)
ACTH: Change from week 0 to week 30	0.4 (4.4)	0.5 (3.9)
ACTH: Change from week 0 to week 56	0.6 (4.9)	0.6 (3.8)
ACTH: Change from week 56 to week 82	-0.8 (4.7)	-0.4 (2.9)

48. Secondary Outcome

Title	Change in Hormone Level: IGF-1 and Cortisol
Description	Change in hormone levels, "insulin-like growth factor-1 (IGF-1) and cortisol" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
IGF-1: Change from week 0 to week 30	10.61 (89.83)	3.79 (101.12)
IGF-1: Change from week 0 to week 56	-4.60 (84.51)	3.69 (111.63)
IGF-1: Change from week 56 to week 82	-14.60 (80.82)	-16.35 (65.89)
Cortisol: Change from week 0 to week 30	6.9 (66.9)	8.6 (60.1)
Cortisol: Change from week 0 to week 56	5.1 (65.2)	8.5 (57.9)
Cortisol: Change from week 56 to week 82	0.6 (66.6)	10.4 (61.2)

49. Secondary Outcome

Title	Change in Hormone Level: DHEAS
Description	Change in dehydroepiandrosterone sulfate (DHEAS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	0.94 (1.66)	0.57 (1.78)
Change from week 0 to week 56	0.95 (1.91)	0.89 (2.05)
Change from week 56 to week 82	-0.08 (2.11)	-0.05 (1.27)

50. Secondary Outcome

Title	Change in Hormone Level: LH and FSH
Description	Change in hormone levels, "luteinising hormone (LH) and follicle stimulating hormone (FSH)" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
LH: Change from week 0 to week 30	0.4 (9.1)	0.7 (7.9)
LH: Change from week 0 to week 56	0.2 (9.1)	0.6 (6.6)
LH: Change from week 56 to week 82	0.4 (8.7)	-0.5 (8.0)
FSH: Change from week 0 to week 30	0.2 (2.6)	-0.2 (2.7)
FSH: Change from week 0 to week 56	0.6 (4.0)	0.1 (2.5)
FSH: Change from week 56 to week 82	-0.1 (3.6)	-0.1 (3.1)

51. Secondary Outcome

Title	Change in Hormone Level: Estradiol (Females)
Description	Change in estradiol (only for female) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	71	78
Change from week 0 to week 30	-5.0 (81.0)	20.2 (67.6)
Change from week 0 to week 56	11.6 (94.4)	14.1 (63.6)
Change from week 56 to week 82	-2.3 (89.1)	-1.7 (65.3)

52. Secondary Outcome

Title	Change in Hormone Level: Testosterone (Males)
Description	This outcome measure presents "testosterone (only for males) results" for baseline (week 0), week 30, week 56 and week 82. ADVIA Centaur Testosterone (TSTO) assay was used for the evaluation of testosterone hormone. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	Week 0, week 30, week 56 and week 82

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	54	48
Week 0	8.13 (3.45)	8.06 (3.66)
Week 30	10.00 (4.02)	9.33 (5.27)
Week 56	10.55 (4.14)	9.51 (3.31)
Week 82	11.36 (5.27)	6.16 (3.27)

53. Secondary Outcome

Title	Change in NTX1
Description	Change in type I collagen N-telopeptide (NTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are presented in "nmol bone collagen equivalents (BCE)/L". Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-2.4 (10.4)	-3.2 (12.0)
Change from week 0 to week 56	-3.7 (14.1)	-2.9 (15.1)
Change from week 56 to week 82	-2.8 (12.8)	-4.6 (10.0)

54. Secondary Outcome

Title	Change in CTX1
Description	Change in type I collagen C-telopeptide (CTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-7 (358)	-84 (404)
Change from week 0 to week 56	-36 (353)	-97 (473)
Change from week 56 to week 82	-107 (359)	-162 (318)

55. Secondary Outcome

Title	Change in P1NP
Description	Change in procollagen 1 N-terminal propeptide (P1NP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-35 (124)	-30 (184)
Change from week 0 to week 56	-55 (151)	-63 (192)
Change from week 56 to week 82	-30 (107)	-47 (84)

56. Secondary Outcome

Title	Change in Alkaline Phosphatase (Bone)
Description	Change in alkaline phosphatase (bone specific) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-15 (16)	-12 (26)
Change from week 0 to week 56	-17 (18)	-17 (30)
Change from week 56 to week 82	-1 (11)	-4 (12)

57. Secondary Outcome

Title	Change in Pubertal Status
Description	This outcome measure presents "pubertal status results" which is based on Tanner staging (Tanner stage 2-5), recorded at baseline (week 0), week 30, week 56 and week 82. Results are presented for the following categories: 1) For female: breast development and pubic hair development (by Tanner staging). 2) For male: penis development and pubic hair development (by Tanner staging). Each category shows number of participants in stages 2 to 5, where stage 2 represents "early pubertal development" and stage 5 represents "pubertal development equivalent to that of an adult". Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Stage 2	2 1.6%	1 0.8%
Stage 3	6 4.8%	8 6.3%
Stage 4	23 18.4%	30 23.8%
Stage 5	40 32%	39 31%
Stage 2	1 0.8%	0 0%
Stage 3	4 3.2%	6 4.8%
Stage 4	22 17.6%	25 19.8%
Stage 5	39 31.2%	43 34.1%
Stage 2	0 0%	0 0%
Stage 3	2 1.6%	2 1.6%
Stage 4	14 11.2%	20 15.9%
Stage 5	41 32.8%	41 32.5%
Stage 2	0 0%	0 0%
Stage 3	0 0%	2 1.6%
Stage 4	7 5.6%	13 10.3%
Stage 5	46 36.8%	46 36.5%
Stage 2	2 1.6%	3 2.4%
Stage 3	6 4.8%	5 4%
Stage 4	22 17.6%	26 20.6%
Stage 5	41 32.8%	44 34.9%
Stage 2	1 0.8%	0 0%
Stage 3	4 3.2%	4 3.2%
Stage 4	20 16%	25 19.8%
Stage 5	41 32.8%	45 35.7%
Stage 2	1 0.8%	0 0%
Stage 3	2 1.6%	2 1.6%
Stage 4	13 10.4%	21 16.7%
Stage 5	41 32.8%	40 31.7%
Stage 2	0 0%	0 0%
Stage 3	1 0.8%	2 1.6%
Stage 4	7 5.6%	14 11.1%
Stage 5	45 36%	45 35.7%
Stage 2	4 3.2%	7 5.6%
Stage 3	11 8.8%	8 6.3%
Stage 4	16 12.8%	14 11.1%
Stage 5	23 18.4%	19 15.1%
Stage 2	1 0.8%	2 1.6%
Stage 3	11 8.8%	7 5.6%
Stage 4	14 11.2%	11 8.7%
Stage 5	25 20%	25 19.8%
Stage 2	1 0.8%	0 0%
Stage 3	6 4.8%	6 4.8%
Stage 4	15 12%	6 4.8%
Stage 5	26 20.8%	29 23%
Stage 2	0 0%	0 0%
Stage 3	3 2.4%	3 2.4%
Stage 4	11 8.8%	6 4.8%
Stage 5	31 24.8%	29 23%
Stage 2	6 4.8%	9 7.1%
Stage 3	8 6.4%	5 4%
Stage 4	19 15.2%	13 10.3%
Stage 5	21 16.8%	21 16.7%
Stage 2	1 0.8%	3 2.4%
Stage 3	10 8%	7 5.6%
Stage 4	15 12%	9 7.1%
Stage 5	24 19.2%	26 20.6%
Stage 2	1 0.8%	0 0%
Stage 3	7 5.6%	6 4.8%
Stage 4	15 12%	7 5.6%
Stage 5	24 19.2%	28 22.2%
Stage 2	0 0%	0 0%
Stage 3	3 2.4%	2 1.6%
Stage 4	10 8%	8 6.3%
Stage 5	30 24%	28 22.2%

58. Secondary Outcome

Title	Change in Physical Examination
Description	This outcome measure presents number of subjects with physical examination findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" at baseline (week 0), week 30, week 56 and week 82. 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". Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	Week 0, week 30, week 56 and week 82

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Normal	93 74.4%	101 80.2%
Abnormal, NCS	30 24%	23 18.3%
Abnormal, CS	2 1.6%	2 1.6%
Normal	94 75.2%	95 75.4%
Abnormal, NCS	21 16.8%	20 15.9%
Abnormal, CS	1 0.8%	1 0.8%
Normal	84 67.2%	85 67.5%
Abnormal, NCS	18 14.4%	16 12.7%
Abnormal, CS	2 1.6%	1 0.8%
Normal	80 64%	81 64.3%
Abnormal, NCS	18 14.4%	17 13.5%
Abnormal, CS	1 0.8%	1 0.8%
Normal	120 96%	116 92.1%
Abnormal, NCS	5 4%	10 7.9%
Abnormal, CS	0 0%	0 0%
Normal	114 91.2%	107 84.9%
Abnormal, NCS	2 1.6%	9 7.1%
Abnormal, CS	0 0%	0 0%
Normal	101 80.8%	98 77.8%
Abnormal, NCS	3 2.4%	4 3.2%
Abnormal, CS	0 0%	0 0%
Normal	98 78.4%	94 74.6%
Abnormal, NCS	1 0.8%	5 4%
Abnormal, CS	0 0%	0 0%
Normal	125 100%	123 97.6%
Abnormal, NCS	0 0%	3 2.4%
Abnormal, CS	0 0%	0 0%
Normal	116 92.8%	115 91.3%
Abnormal, NCS	0 0%	1 0.8%
Abnormal, CS	0 0%	0 0%
Normal	104 83.2%	101 80.2%
Abnormal, NCS	0 0%	1 0.8%
Abnormal, CS	0 0%	0 0%
Normal	99 79.2%	96 76.2%
Abnormal, NCS	0 0%	3 2.4%
Abnormal, CS	0 0%	0 0%
Normal	124 99.2%	125 99.2%
Abnormal, NCS	1 0.8%	1 0.8%
Abnormal, CS	0 0%	0 0%
Normal	115 92%	112 88.9%
Abnormal, NCS	1 0.8%	4 3.2%
Abnormal, CS	0 0%	0 0%
Normal	102 81.6%	100 79.4%
Abnormal, NCS	2 1.6%	2 1.6%
Abnormal, CS	0 0%	0 0%
Normal	97 77.6%	98 77.8%
Abnormal, NCS	2 1.6%	1 0.8%
Abnormal, CS	0 0%	0 0%
Normal	119 95.2%	119 94.4%
Abnormal, NCS	5 4%	6 4.8%
Abnormal, CS	1 0.8%	1 0.8%
Normal	111 88.8%	109 86.5%
Abnormal, NCS	5 4%	6 4.8%
Abnormal, CS	0 0%	1 0.8%
Normal	102 81.6%	98 77.8%
Abnormal, NCS	2 1.6%	4 3.2%
Abnormal, CS	0 0%	0 0%
Normal	96 76.8%	94 74.6%
Abnormal, NCS	1 0.8%	5 4%
Abnormal, CS	2 1.6%	0 0%
Normal	121 96.8%	119 94.4%
Abnormal, NCS	4 3.2%	7 5.6%
Abnormal, CS	0 0%	0 0%
Normal	113 90.4%	106 84.1%
Abnormal, NCS	3 2.4%	10 7.9%
Abnormal, CS	0 0%	0 0%
Normal	102 81.6%	97 77%
Abnormal, NCS	1 0.8%	5 4%
Abnormal, CS	1 0.8%	0 0%
Normal	97 77.6%	92 73%
Abnormal, NCS	1 0.8%	7 5.6%
Abnormal, CS	1 0.8%	0 0%
Normal	124 99.2%	124 98.4%
Abnormal, NCS	1 0.8%	2 1.6%
Abnormal, CS	0 0%	0 0%
Normal	115 92%	115 91.3%
Abnormal, NCS	1 0.8%	1 0.8%
Abnormal, CS	0 0%	0 0%
Normal	104 83.2%	101 80.2%
Abnormal, NCS	0 0%	1 0.8%
Abnormal, CS	0 0%	0 0%
Normal	99 79.2%	98 77.8%
Abnormal, NCS	0 0%	1 0.8%
Abnormal, CS	0 0%	0 0%
Normal	76 60.8%	58 46%
Abnormal, NCS	47 37.6%	64 50.8%
Abnormal, CS	2 1.6%	4 3.2%
Normal	71 56.8%	56 44.4%
Abnormal, NCS	44 35.2%	56 44.4%
Abnormal, CS	1 0.8%	4 3.2%
Normal	65 52%	48 38.1%
Abnormal, NCS	35 28%	53 42.1%
Abnormal, CS	4 3.2%	1 0.8%
Normal	57 45.6%	50 39.7%
Abnormal, NCS	40 32%	48 38.1%
Abnormal, CS	2 1.6%	1 0.8%
Normal	124 99.2%	124 98.4%
Abnormal, NCS	1 0.8%	2 1.6%
Abnormal, CS	0 0%	0 0%
Normal	115 92%	114 90.5%
Abnormal, NCS	1 0.8%	2 1.6%
Abnormal, CS	0 0%	0 0%
Normal	103 82.4%	101 80.2%
Abnormal, NCS	1 0.8%	1 0.8%
Abnormal, CS	0 0%	0 0%
Normal	97 77.6%	98 77.8%
Abnormal, NCS	2 1.6%	1 0.8%
Abnormal, CS	0 0%	0 0%
Normal	124 99.2%	125 99.2%
Abnormal, NCS	1 0.8%	1 0.8%
Abnormal, CS	0 0%	0 0%
Normal	115 92%	116 92.1%
Abnormal, NCS	1 0.8%	0 0%
Abnormal, CS	0 0%	0 0%
Normal	103 82.4%	102 81%
Abnormal, NCS	1 0.8%	0 0%
Abnormal, CS	0 0%	0 0%
Normal	98 78.4%	98 77.8%
Abnormal, NCS	1 0.8%	1 0.8%
Abnormal, CS	0 0%	0 0%

59. Secondary Outcome

Title	Change in Height SDS
Description	Change in height standard deviation score (SDS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	0.11 (0.17)	0.13 (0.18)
Change from week 0 to week 56	0.20 (0.27)	0.24 (0.30)
Change from week 56 to week 82	0.07 (0.16)	0.06 (0.12)

60. Secondary Outcome

Title	Change in C-SSRS
Description	This outcome measure presents number of subjects with "suicidal ideation or suicidal behaviour on the Columbia Suicidality Severity Rating Scale (C-SSRS)" assessed at baseline (week 0), week 30, week 56 and week 82. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Wk 0: Suicidal ideation	2 1.6%	2 1.6%
Wk 0: Suicidal behaviour	0 0%	1 0.8%
Wk0: Self-injurious behaviour, no suicidal intent	0 0%	1 0.8%
Wk 30: Suicidal ideation	0 0%	0 0%
Wk 30: Suicidal behaviour	0 0%	0 0%
Wk30: Self-injurious behaviour, no suicidal intent	0 0%	0 0%
Wk 56: Suicidal ideation	0 0%	0 0%
Wk 56: Suicidal behaviour	0 0%	0 0%
Wk56: Self-injurious behaviour, no suicidal intent	0 0%	0 0%
Wk 82: Suicidal ideation	0 0%	0 0%
Wk 82: Suicidal behaviour	0 0%	0 0%
Wk82: Self-injurious behaviour, no suicidal intent	0 0%	0 0%

61. Secondary Outcome

Title	Change in PHQ-9
Description	Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. 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. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame	(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Outcome Measure Data

Analysis Population Description

Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Liraglutide 3.0 mg	Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.	Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Measure Participants	125	126
Change from week 0 to week 30	-1 (4)	-1 (4)
Change from week 0 to week 56	-1 (3)	-2 (3)
Change from week 56 to week 82	0 (2)	-0 (3)

Adverse Events

Time Frame	Week 0-56 + 14 days. Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product.
Adverse Event Reporting Description	All presented adverse events are TEAEs. A TEAE was defined as an event that occurred in the "on-treatment" period. 'On-treatment' period: Events with onset date between the first day of trial product administration and any of the following date, whichever came first: 1) 14 days after the last day on trial product, or 2) follow-up visit (week 58) for participants who discontinued trial product, or 3) last study visit (participants withdrawn without follow-up visit).
Arm/Group Title	Liraglutide 3.0 mg		Placebo
Arm/Group Description	Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.		Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
All Cause Mortality
	Liraglutide 3.0 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/125 (0.8%)		0/126 (0%)
Serious Adverse Events
	Liraglutide 3.0 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/125 (2.4%)		5/126 (4%)
Hepatobiliary disorders
Cholecystitis acute	0/125 (0%)	0	1/126 (0.8%)	1
Cholelithiasis	0/125 (0%)	0	1/126 (0.8%)	1
Infections and infestations
Appendicitis	0/125 (0%)	0	1/126 (0.8%)	1
Pneumonia	0/125 (0%)	0	1/126 (0.8%)	1
Injury, poisoning and procedural complications
Post procedural haemorrhage	1/125 (0.8%)	1	0/126 (0%)	0
Musculoskeletal and connective tissue disorders
Myositis	1/125 (0.8%)	1	0/126 (0%)	0
Psychiatric disorders
Completed suicide	1/125 (0.8%)	1	0/126 (0%)	0
Reproductive system and breast disorders
Haemorrhagic ovarian cyst	0/125 (0%)	0	1/126 (0.8%)	1
Vascular disorders
Thrombophlebitis	0/125 (0%)	0	1/126 (0.8%)	1
Other (Not Including Serious) Adverse Events
	Liraglutide 3.0 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	100/125 (80%)		84/126 (66.7%)
Gastrointestinal disorders
Abdominal pain	10/125 (8%)	15	11/126 (8.7%)	15
Abdominal pain upper	17/125 (13.6%)	25	17/126 (13.5%)	23
Diarrhoea	28/125 (22.4%)	44	18/126 (14.3%)	29
Nausea	53/125 (42.4%)	101	18/126 (14.3%)	25
Vomiting	43/125 (34.4%)	85	5/126 (4%)	8
General disorders
Pyrexia	10/125 (8%)	11	9/126 (7.1%)	11
Infections and infestations
Gastroenteritis	16/125 (12.8%)	22	6/126 (4.8%)	9
Influenza	11/125 (8.8%)	11	12/126 (9.5%)	12
Nasopharyngitis	34/125 (27.2%)	68	38/126 (30.2%)	80
Pharyngitis	4/125 (3.2%)	5	7/126 (5.6%)	7
Upper respiratory tract infection	11/125 (8.8%)	14	11/126 (8.7%)	16
Musculoskeletal and connective tissue disorders
Arthralgia	3/125 (2.4%)	3	8/126 (6.3%)	8
Nervous system disorders
Dizziness	13/125 (10.4%)	15	4/126 (3.2%)	5
Headache	29/125 (23.2%)	43	35/126 (27.8%)	53
Reproductive system and breast disorders
Dysmenorrhoea	4/125 (3.2%)	5	8/126 (6.3%)	16
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	11/125 (8.8%)	11	15/126 (11.9%)	18

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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