Trial Outcomes & Findings for Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity (NCT NCT02918279)

Last Updated: 2020-04-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

251 participants

Primary outcome timeframe

Week 0, week 56

Results posted on

2020-04-27

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Liraglutide 3.0 mg 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.	Placebo 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.
Overall Study STARTED	125	126
Overall Study Full Analysis Set	125	126
Overall Study Safety Analysis Set	125	126
Overall Study COMPLETED	112	103
Overall Study NOT COMPLETED	13	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Liraglutide 3.0 mg 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.	Placebo 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.
Overall Study Lost to Follow-up	3	6
Overall Study Withdrawal by Subject	5	15
Overall Study Withdrawal by parent/guardian	2	1
Overall Study Other	3	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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 n=251 Participants Total of all reporting groups
Age, Continuous	14.6 Years STANDARD_DEVIATION 1.6 • n=5 Participants	14.5 Years STANDARD_DEVIATION 1.6 • n=7 Participants	14.5 Years STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	78 Participants n=7 Participants	149 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	48 Participants n=7 Participants	102 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=5 Participants	24 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	93 Participants n=5 Participants	102 Participants n=7 Participants	195 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	105 Participants n=5 Participants	115 Participants n=7 Participants	220 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 0, week 56

Population: 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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=113 Participants 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.	Placebo n=105 Participants 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.
Change in BMI SDS (Week 0, Week 56)	-0.25 SDS score Standard Deviation 0.51	-0.02 SDS score Standard Deviation 0.54

SECONDARY outcome

Timeframe: Weeks 30, 56 and 82

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Percent of Subjects Achieving ≥5% Reduction in Baseline BMI Week 30 (Yes)	46.2 Percentage of participants	14.7 Percentage of participants
Percent of Subjects Achieving ≥5% Reduction in Baseline BMI Week 30 (No)	53.8 Percentage of participants	85.3 Percentage of participants
Percent of Subjects Achieving ≥5% Reduction in Baseline BMI Week 56 (Yes)	45.1 Percentage of participants	19.0 Percentage of participants
Percent of Subjects Achieving ≥5% Reduction in Baseline BMI Week 56 (No)	54.9 Percentage of participants	81.0 Percentage of participants
Percent of Subjects Achieving ≥5% Reduction in Baseline BMI Week 82 (Yes)	29.5 Percentage of participants	18.6 Percentage of participants
Percent of Subjects Achieving ≥5% Reduction in Baseline BMI Week 82 (No)	70.5 Percentage of participants	81.4 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Percent of Subjects Achieving ≥10% Reduction in Baseline BMI Week 30 (Yes)	24.4 Percentage of participants	5.2 Percentage of participants
Percent of Subjects Achieving ≥10% Reduction in Baseline BMI Week 30 (No)	75.6 Percentage of participants	94.8 Percentage of participants
Percent of Subjects Achieving ≥10% Reduction in Baseline BMI Week 56 (Yes)	29.2 Percentage of participants	8.6 Percentage of participants
Percent of Subjects Achieving ≥10% Reduction in Baseline BMI Week 56 (No)	70.8 Percentage of participants	91.4 Percentage of participants
Percent of Subjects Achieving ≥10% Reduction in Baseline BMI Week 82 (Yes)	18.8 Percentage of participants	10.8 Percentage of participants
Percent of Subjects Achieving ≥10% Reduction in Baseline BMI Week 82 (No)	81.3 Percentage of participants	89.2 Percentage of participants

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82)) Change from week 0 to week 30	-0.26 SDS score Standard Deviation 0.34	-0.04 SDS score Standard Deviation 0.33
Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82)) Change from week 0 to week 82	-0.06 SDS score Standard Deviation 0.53	0.07 SDS score Standard Deviation 0.66
Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82)) Change from week 56 to week 82	0.22 SDS score Standard Deviation 0.28	0.08 SDS score Standard Deviation 0.27

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in BMI Change from week 0 to week 30	-1.8 kg/m^2 Standard Deviation 2.1	-0.2 kg/m^2 Standard Deviation 2.2
Change in BMI Change from week 0 to week 56	-1.6 kg/m^2 Standard Deviation 3.1	0.1 kg/m^2 Standard Deviation 3.4
Change in BMI Change from week 56 to week 82	1.5 kg/m^2 Standard Deviation 1.7	0.7 kg/m^2 Standard Deviation 1.7

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Body Weight (kg) Change from week 0 to week 30	-3.9 kg Standard Deviation 6.1	0.4 kg Standard Deviation 6.6
Change in Body Weight (kg) Change from week 0 to week 56	-2.7 kg Standard Deviation 9.1	2.1 kg Standard Deviation 10.2
Change in Body Weight (kg) Change from week 56 to week 82	4.7 kg Standard Deviation 4.6	2.4 kg Standard Deviation 4.9

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Body Weight (%) Change from week 0 to week 30	-4.3 Percentage change Standard Deviation 6.5	0.4 Percentage change Standard Deviation 6.2
Change in Body Weight (%) Change from week 0 to week 56	-3.2 Percentage change Standard Deviation 9.4	2.2 Percentage change Standard Deviation 9.5
Change in Body Weight (%) Change from week 56 to week 82	5.3 Percentage change Standard Deviation 5.7	2.3 Percentage change Standard Deviation 4.9

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: Body weight was not analysed in pounds (lb).

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Waist Circumference Change from week 0 to week 30	-4.63 cm Standard Deviation 6.24	-2.01 cm Standard Deviation 5.94
Change in Waist Circumference Change from week 0 to week 56	-5.12 cm Standard Deviation 7.87	-1.51 cm Standard Deviation 8.20
Change in Waist Circumference Change from week 56 to week 82	3.58 cm Standard Deviation 4.30	1.24 cm Standard Deviation 5.60

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Waist-to-hip Circumference Ratio Change from week 0 to week 30	-0.015 Ratio Standard Deviation 0.042	-0.018 Ratio Standard Deviation 0.042
Change in Waist-to-hip Circumference Ratio Change from week 0 to week 56	-0.022 Ratio Standard Deviation 0.053	-0.023 Ratio Standard Deviation 0.051
Change in Waist-to-hip Circumference Ratio Change from week 56 to week 82	0.010 Ratio Standard Deviation 0.031	0.003 Ratio Standard Deviation 0.049

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in hsCRP Change from week 56 to week 82	1.51 mg/L Standard Deviation 7.61	1.00 mg/L Standard Deviation 4.22
Change in hsCRP Change from week 0 to week 30	-0.22 mg/L Standard Deviation 5.04	-0.56 mg/L Standard Deviation 4.68
Change in hsCRP Change from week 0 to week 56	-0.25 mg/L Standard Deviation 4.54	-0.14 mg/L Standard Deviation 3.44

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline) Change from week 0 to week 30	1.00 Ratio of total cholesterol Geometric Coefficient of Variation 12.8	0.98 Ratio of total cholesterol Geometric Coefficient of Variation 13.0
Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline) Change from week 0 to week 56	1.00 Ratio of total cholesterol Geometric Coefficient of Variation 14.2	1.00 Ratio of total cholesterol Geometric Coefficient of Variation 13.0
Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline) Change from week 56 to week 82	1.02 Ratio of total cholesterol Geometric Coefficient of Variation 14.7	1.02 Ratio of total cholesterol Geometric Coefficient of Variation 14.9

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline) Change from week 0 to week 30	1.00 Ratio of LDL-cholesterol Geometric Coefficient of Variation 19.8	1.00 Ratio of LDL-cholesterol Geometric Coefficient of Variation 26.1
Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline) Change from week 0 to week 56	0.99 Ratio of LDL-cholesterol Geometric Coefficient of Variation 21.8	1.02 Ratio of LDL-cholesterol Geometric Coefficient of Variation 23.6
Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline) Change from week 56 to week 82	1.03 Ratio of LDL-cholesterol Geometric Coefficient of Variation 22.5	1.04 Ratio of LDL-cholesterol Geometric Coefficient of Variation 20.6

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline) Change from week 0 to week 30	1.04 Ratio of HDL-cholesterol Geometric Coefficient of Variation 15.3	1.01 Ratio of HDL-cholesterol Geometric Coefficient of Variation 20.5
Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline) Change from week 0 to week 56	1.04 Ratio of HDL-cholesterol Geometric Coefficient of Variation 17.4	1.02 Ratio of HDL-cholesterol Geometric Coefficient of Variation 18.9
Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline) Change from week 56 to week 82	0.99 Ratio of HDL-cholesterol Geometric Coefficient of Variation 15.8	1.00 Ratio of HDL-cholesterol Geometric Coefficient of Variation 15.2

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline) Change from week 0 to week 30	0.98 Ratio of non-HDL cholesterol Geometric Coefficient of Variation 16.8	0.97 Ratio of non-HDL cholesterol Geometric Coefficient of Variation 18.0
Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline) Change from week 0 to week 56	0.98 Ratio of non-HDL cholesterol Geometric Coefficient of Variation 18.4	0.99 Ratio of non-HDL cholesterol Geometric Coefficient of Variation 16.7
Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline) Change from week 56 to week 82	1.03 Ratio of non-HDL cholesterol Geometric Coefficient of Variation 19.8	1.02 Ratio of non-HDL cholesterol Geometric Coefficient of Variation 18.6

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline) Change from week 0 to week 30	0.91 Ratio of VLDL cholesterol Geometric Coefficient of Variation 36.8	0.90 Ratio of VLDL cholesterol Geometric Coefficient of Variation 42.7
Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline) Change from week 0 to week 56	0.92 Ratio of VLDL cholesterol Geometric Coefficient of Variation 43.7	0.93 Ratio of VLDL cholesterol Geometric Coefficient of Variation 34.6
Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline) Change from week 56 to week 82	1.04 Ratio of VLDL cholesterol Geometric Coefficient of Variation 51.0	0.97 Ratio of VLDL cholesterol Geometric Coefficient of Variation 34.1

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Fasting Lipid: Triglycerides (Ratio to Baseline) Change from week 0 to week 30	0.91 Ratio of triglycerides Geometric Coefficient of Variation 36.9	0.91 Ratio of triglycerides Geometric Coefficient of Variation 42.9
Change in Fasting Lipid: Triglycerides (Ratio to Baseline) Change from week 0 to week 56	0.92 Ratio of triglycerides Geometric Coefficient of Variation 43.2	0.93 Ratio of triglycerides Geometric Coefficient of Variation 34.4
Change in Fasting Lipid: Triglycerides (Ratio to Baseline) Change from week 56 to week 82	1.04 Ratio of triglycerides Geometric Coefficient of Variation 50.4	0.97 Ratio of triglycerides Geometric Coefficient of Variation 34.0

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Fasting Lipid: FFA (Ratio to Baseline) Change from week 0 to week 30	0.96 Ratio of FFA Geometric Coefficient of Variation 57.7	0.83 Ratio of FFA Geometric Coefficient of Variation 56.4
Change in Fasting Lipid: FFA (Ratio to Baseline) Change from week 0 to week 56	1.00 Ratio of FFA Geometric Coefficient of Variation 48.9	0.95 Ratio of FFA Geometric Coefficient of Variation 50.8
Change in Fasting Lipid: FFA (Ratio to Baseline) Change from week 56 to week 82	0.99 Ratio of FFA Geometric Coefficient of Variation 55.2	0.94 Ratio of FFA Geometric Coefficient of Variation 38.0

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Systolic and Diastolic Blood Pressure SBP: Change from week 0 to week 30	-2 mmHg Standard Deviation 9	-1 mmHg Standard Deviation 10
Change in Systolic and Diastolic Blood Pressure SBP: Change from week 0 to week 56	-2 mmHg Standard Deviation 10	1 mmHg Standard Deviation 10
Change in Systolic and Diastolic Blood Pressure SBP: Change from week 56 to week 82	2 mmHg Standard Deviation 9	1 mmHg Standard Deviation 10
Change in Systolic and Diastolic Blood Pressure DBP: Change from week 0 to week 30	-0 mmHg Standard Deviation 8	-1 mmHg Standard Deviation 10
Change in Systolic and Diastolic Blood Pressure DBP: Change from week 0 to week 56	1 mmHg Standard Deviation 9	-1 mmHg Standard Deviation 9
Change in Systolic and Diastolic Blood Pressure DBP: Change from week 56 to week 82	2 mmHg Standard Deviation 8	2 mmHg Standard Deviation 7

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in HbA1c Change from week 0 to week 30	-0.1 Percentage of HbA1c Standard Deviation 0.3	-0.0 Percentage of HbA1c Standard Deviation 0.3
Change in HbA1c Change from week 0 to week 56	-0.1 Percentage of HbA1c Standard Deviation 0.3	-0.0 Percentage of HbA1c Standard Deviation 0.2
Change in HbA1c Change from week 56 to week 82	0.1 Percentage of HbA1c Standard Deviation 0.2	0.1 Percentage of HbA1c Standard Deviation 0.3

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in FPG Change from week 0 to week 30	-0.2 mmol/L Standard Deviation 0.4	-0.0 mmol/L Standard Deviation 0.5
Change in FPG Change from week 0 to week 56	-0.1 mmol/L Standard Deviation 0.5	-0.0 mmol/L Standard Deviation 0.6
Change in FPG Change from week 56 to week 82	0.1 mmol/L Standard Deviation 0.6	0.1 mmol/L Standard Deviation 0.5

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Fasting Insulin (Ratio to Baseline) Change from week 0 to week 30	1.13 Ratio of fasting insulin Geometric Coefficient of Variation 70.9	1.14 Ratio of fasting insulin Geometric Coefficient of Variation 53.7
Change in Fasting Insulin (Ratio to Baseline) Change from week 0 to week 56	1.06 Ratio of fasting insulin Geometric Coefficient of Variation 69.4	1.10 Ratio of fasting insulin Geometric Coefficient of Variation 73.8
Change in Fasting Insulin (Ratio to Baseline) Change from week 56 to week 82	1.00 Ratio of fasting insulin Geometric Coefficient of Variation 60.9	1.08 Ratio of fasting insulin Geometric Coefficient of Variation 55.2

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Fasting C-peptide (Ratio to Baseline) Change from week 0 to week 30	1.12 Ratio of fasting C-peptide Geometric Coefficient of Variation 42.6	1.04 Ratio of fasting C-peptide Geometric Coefficient of Variation 35.1
Change in Fasting C-peptide (Ratio to Baseline) Change from week 0 to week 56	0.98 Ratio of fasting C-peptide Geometric Coefficient of Variation 44.9	0.97 Ratio of fasting C-peptide Geometric Coefficient of Variation 47.4
Change in Fasting C-peptide (Ratio to Baseline) Change from week 56 to week 82	0.92 Ratio of fasting C-peptide Geometric Coefficient of Variation 43.6	0.94 Ratio of fasting C-peptide Geometric Coefficient of Variation 32.9

SECONDARY outcome

Timeframe: Week -2, week 30, week 56 and week 82

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Glycaemic Category Week -2 · Normoglycaemia	93 Participants	93 Participants
Change in Glycaemic Category Week -2 · Pre-diabetes	31 Participants	32 Participants
Change in Glycaemic Category Week -2 · Type 2 diabetes	1 Participants	1 Participants
Change in Glycaemic Category Week 30 · Normoglycaemia	95 Participants	86 Participants
Change in Glycaemic Category Week 30 · Pre-diabetes	19 Participants	29 Participants
Change in Glycaemic Category Week 30 · Type 2 diabetes	2 Participants	1 Participants
Change in Glycaemic Category Week 56 · Normoglycaemia	86 Participants	75 Participants
Change in Glycaemic Category Week 56 · Pre-diabetes	17 Participants	24 Participants
Change in Glycaemic Category Week 56 · Type 2 diabetes	2 Participants	2 Participants
Change in Glycaemic Category Week 82 · Normoglycaemia	79 Participants	65 Participants
Change in Glycaemic Category Week 82 · Pre-diabetes	20 Participants	30 Participants
Change in Glycaemic Category Week 82 · Type 2 diabetes	1 Participants	4 Participants

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in HOMA-B (Ratio to Baseline) Change from week 56 to week 82	0.92 Ratio of HOMA-B Geometric Coefficient of Variation 65.9	1.02 Ratio of HOMA-B Geometric Coefficient of Variation 50.2
Change in HOMA-B (Ratio to Baseline) Change from week 0 to week 30	1.32 Ratio of HOMA-B Geometric Coefficient of Variation 70.8	1.17 Ratio of HOMA-B Geometric Coefficient of Variation 59.5
Change in HOMA-B (Ratio to Baseline) Change from week 0 to week 56	1.13 Ratio of HOMA-B Geometric Coefficient of Variation 67.0	1.11 Ratio of HOMA-B Geometric Coefficient of Variation 58.0

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in HOMA-IR (Ratio to Baseline) Change from week 0 to week 30	1.08 Ratio of HOMA-IR Geometric Coefficient of Variation 75.2	1.14 Ratio of HOMA-IR Geometric Coefficient of Variation 55.6
Change in HOMA-IR (Ratio to Baseline) Change from week 0 to week 56	1.04 Ratio of HOMA-IR Geometric Coefficient of Variation 75.3	1.09 Ratio of HOMA-IR Geometric Coefficient of Variation 80.0
Change in HOMA-IR (Ratio to Baseline) Change from week 56 to week 82	1.03 Ratio of HOMA-IR Geometric Coefficient of Variation 64.2	1.11 Ratio of HOMA-IR Geometric Coefficient of Variation 60.5

SECONDARY outcome

Timeframe: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in IWQOL-Kids Body Esteem: Change from week 0 to week 30	10.62 Scores on a scale Standard Deviation 19.88	6.73 Scores on a scale Standard Deviation 26.87
Change in IWQOL-Kids Body Esteem: Change from week 0 to week 56	13.33 Scores on a scale Standard Deviation 19.47	13.24 Scores on a scale Standard Deviation 22.72
Change in IWQOL-Kids Family Relation: Change from week 0 to week 30	2.53 Scores on a scale Standard Deviation 9.66	-2.19 Scores on a scale Standard Deviation 17.53
Change in IWQOL-Kids Family Relation: Change from week 0 to week 56	1.44 Scores on a scale Standard Deviation 14.31	0.97 Scores on a scale Standard Deviation 5.61
Change in IWQOL-Kids Physical Function: Change from week 0 to week 30	3.94 Scores on a scale Standard Deviation 15.34	0.43 Scores on a scale Standard Deviation 22.02
Change in IWQOL-Kids Physical Function: Change from week 0 to week 56	6.17 Scores on a scale Standard Deviation 15.44	3.32 Scores on a scale Standard Deviation 16.60
Change in IWQOL-Kids Social Life: Change from week 0 to week 30	5.32 Scores on a scale Standard Deviation 10.56	1.76 Scores on a scale Standard Deviation 21.98
Change in IWQOL-Kids Social Life: Change from week 0 to week 56	5.97 Scores on a scale Standard Deviation 19.48	6.06 Scores on a scale Standard Deviation 14.04
Change in IWQOL-Kids Total: Change from week 0 to week 30	6.16 Scores on a scale Standard Deviation 11.04	2.24 Scores on a scale Standard Deviation 19.69
Change in IWQOL-Kids Total: Change from week 0 to week 56	7.46 Scores on a scale Standard Deviation 13.70	6.72 Scores on a scale Standard Deviation 11.62

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in BMI SDS (%) Change from week 0 to week 56	-8.32 Percentage change Standard Error 1.68	-0.68 Percentage change Standard Error 1.74
Change in BMI SDS (%) Change from week 0 to week 30	-8.73 Percentage change Standard Error 1.05	-1.70 Percentage change Standard Error 1.07

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Nutritional Compliance Week 0	7.10 Score on a scale Standard Deviation 1.74	7.07 Score on a scale Standard Deviation 1.69
Change in Nutritional Compliance Week 30	6.74 Score on a scale Standard Deviation 2.08	6.51 Score on a scale Standard Deviation 1.91
Change in Nutritional Compliance Week 56	6.87 Score on a scale Standard Deviation 1.87	6.45 Score on a scale Standard Deviation 1.84

SECONDARY outcome

Timeframe: Week 0-56 + 14 days

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Number of Treatment Emergent Adverse Events	777 Events	627 Events

SECONDARY outcome

Timeframe: Week 0-56 + 14 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) Severe hypoglycaemia	0 Episodes	0 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) Asymptomatic hypoglycaemia	12 Episodes	17 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) Documented symptomatic hypoglycaemia	31 Episodes	6 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) Probable symptomatic hypoglycaemia	1 Episodes	2 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) Pseudo-hypoglycaemia	30 Episodes	3 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) Unclassifiable	4 Episodes	0 Episodes

SECONDARY outcome

Timeframe: Week 0-56 + 14 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification) Severe hypoglycaemia	0 Episodes	0 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification) Asymptomatic BG-confirmed hypoglycaemia	1 Episodes	1 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification) Symptomatic BG-confirmed hypoglycaemia	4 Episodes	0 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification) Unclassifiable	73 Episodes	27 Episodes

SECONDARY outcome

Timeframe: Weeks 0, 30, 56, 58, 70 and 82

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo 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.
Occurrence of Anti-liraglutide Antibodies Weeks 0	0 Participants	—
Occurrence of Anti-liraglutide Antibodies Weeks 30	6 Participants	—
Occurrence of Anti-liraglutide Antibodies Weeks 56	5 Participants	—
Occurrence of Anti-liraglutide Antibodies Weeks 58	11 Participants	—
Occurrence of Anti-liraglutide Antibodies Weeks 70	6 Participants	—
Occurrence of Anti-liraglutide Antibodies Weeks 82	2 Participants	—

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Pulse Change from week 0 to week 30	4 Beats/minute Standard Deviation 12	-1 Beats/minute Standard Deviation 12
Change in Pulse Change from week 0 to week 56	4 Beats/minute Standard Deviation 11	-1 Beats/minute Standard Deviation 12
Change in Pulse Change from week 56 to week 82	-3 Beats/minute Standard Deviation 9	2 Beats/minute Standard Deviation 11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in ECG Week -14 · Normal	102 Participants	100 Participants
Change in ECG Week -14 · Abnormal, NCS	23 Participants	26 Participants
Change in ECG Week -14 · Abnormal, CS	0 Participants	0 Participants
Change in ECG Week 30 · Normal	97 Participants	95 Participants
Change in ECG Week 30 · Abnormal, NCS	20 Participants	21 Participants
Change in ECG Week 30 · Abnormal, CS	0 Participants	0 Participants
Change in ECG Week 56 · Normal	83 Participants	80 Participants
Change in ECG Week 56 · Abnormal, NCS	21 Participants	23 Participants
Change in ECG Week 56 · Abnormal, CS	0 Participants	0 Participants

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Haematology: Haemoglobin Change from week 0 to week 30	0.2 mmol/L Standard Deviation 0.5	0.0 mmol/L Standard Deviation 0.4
Change in Haematology: Haemoglobin Change from week 0 to week 56	0.3 mmol/L Standard Deviation 0.6	0.1 mmol/L Standard Deviation 0.6
Change in Haematology: Haemoglobin Change from week 56 to week 82	-0.1 mmol/L Standard Deviation 0.6	-0.0 mmol/L Standard Deviation 0.4

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Haematology: Haematocrit Change from week 0 to week 56	1.2 % of red blood cells Standard Deviation 2.7	0.4 % of red blood cells Standard Deviation 2.8
Change in Haematology: Haematocrit Change from week 0 to week 30	0.7 % of red blood cells Standard Deviation 2.3	0.1 % of red blood cells Standard Deviation 2.4
Change in Haematology: Haematocrit Change from week 56 to week 82	-0.4 % of red blood cells Standard Deviation 2.9	-0.4 % of red blood cells Standard Deviation 1.9

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Lymphocytes: Change from week 0 to week 30	-0.18 10^9 cells/L Standard Deviation 0.69	-0.14 10^9 cells/L Standard Deviation 0.62
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Lymphocytes: Change from week 0 to week 56	-0.28 10^9 cells/L Standard Deviation 0.59	-0.27 10^9 cells/L Standard Deviation 0.72
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Lymphocytes: Change from week 56 to week 82	-0.03 10^9 cells/L Standard Deviation 0.48	-0.00 10^9 cells/L Standard Deviation 0.61
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Monocytes: Change from week 0 to week 30	0.04 10^9 cells/L Standard Deviation 0.16	0.00 10^9 cells/L Standard Deviation 0.18
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Monocytes: Change from week 0 to week 56	0.06 10^9 cells/L Standard Deviation 0.13	0.01 10^9 cells/L Standard Deviation 0.17
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Monocytes: Change from week 56 to week 82	-0.00 10^9 cells/L Standard Deviation 0.15	0.04 10^9 cells/L Standard Deviation 0.18
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Thrombocytes: Change from week 0 to week 30	9 10^9 cells/L Standard Deviation 37	14 10^9 cells/L Standard Deviation 38
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Thrombocytes: Change from week 0 to week 56	7 10^9 cells/L Standard Deviation 46	7 10^9 cells/L Standard Deviation 39
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Thrombocytes: Change from week 56 to week 82	-2 10^9 cells/L Standard Deviation 31	3 10^9 cells/L Standard Deviation 37
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Leucocytes: Change from week 0 to week 30	0.1 10^9 cells/L Standard Deviation 1.6	-0.1 10^9 cells/L Standard Deviation 2
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Leucocytes: Change from week 0 to week 56	-0.2 10^9 cells/L Standard Deviation 1.6	-0.4 10^9 cells/L Standard Deviation 1.7
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Leucocytes: Change from week 56 to week 82	0.2 10^9 cells/L Standard Deviation 1.5	0.0 10^9 cells/L Standard Deviation 2.0
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Eosinophils: Change from week 0 to week 30	0.03 10^9 cells/L Standard Deviation 0.15	0.04 10^9 cells/L Standard Deviation 0.29
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Eosinophils: Change from week 0 to week 56	0.01 10^9 cells/L Standard Deviation 0.15	0.00 10^9 cells/L Standard Deviation 0.23
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Eosinophils: Change from week 56 to week 82	-0.01 10^9 cells/L Standard Deviation 0.12	0.00 10^9 cells/L Standard Deviation 0.15
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Neutrophils: Change from week 0 to week 30	0.18 10^9 cells/L Standard Deviation 1.33	-0.01 10^9 cells/L Standard Deviation 1.71
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Neutrophils: Change from week 0 to week 56	-0.01 10^9 cells/L Standard Deviation 1.49	-0.13 10^9 cells/L Standard Deviation 1.50
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Neutrophils: Change from week 56 to week 82	0.21 10^9 cells/L Standard Deviation 1.35	-0.00 10^9 cells/L Standard Deviation 1.71
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Basophils: Change from week 0 to week 30	0.01 10^9 cells/L Standard Deviation 0.03	0.01 10^9 cells/L Standard Deviation 0.03
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Basophils: Change from week 0 to week 56	0.01 10^9 cells/L Standard Deviation 0.03	0.02 10^9 cells/L Standard Deviation 0.03
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes Basophils: Change from week 56 to week 82	0.00 10^9 cells/L Standard Deviation 0.03	0.00 10^9 cells/L Standard Deviation 0.03

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Haematology: Erythrocytes Change from week 0 to week 30	0.0 10^12 cells/L Standard Deviation 0.2	-0.0 10^12 cells/L Standard Deviation 0.3
Change in Haematology: Erythrocytes Change from week 0 to week 56	-0.0 10^12 cells/L Standard Deviation 0.3	-0.1 10^12 cells/L Standard Deviation 0.3
Change in Haematology: Erythrocytes Change from week 56 to week 82	-0.1 10^12 cells/L Standard Deviation 0.3	0.0 10^12 cells/L Standard Deviation 0.2

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Biochemistry: Creatinine and Bilirubin (Total) Creatinine: Change from week 0 to week 30	1 umol/L Standard Deviation 7	0 umol/L Standard Deviation 8
Change in Biochemistry: Creatinine and Bilirubin (Total) Creatinine: Change from week 0 to week 56	2 umol/L Standard Deviation 7	4 umol/L Standard Deviation 9
Change in Biochemistry: Creatinine and Bilirubin (Total) Creatinine: Change from week 56 to week 82	2 umol/L Standard Deviation 8	1 umol/L Standard Deviation 10
Change in Biochemistry: Creatinine and Bilirubin (Total) Bilirubin (total): Change from week 0 to week 30	1 umol/L Standard Deviation 4	1 umol/L Standard Deviation 5
Change in Biochemistry: Creatinine and Bilirubin (Total) Bilirubin (total): Change from week 0 to week 56	1 umol/L Standard Deviation 4	1 umol/L Standard Deviation 5
Change in Biochemistry: Creatinine and Bilirubin (Total) Bilirubin (total): Change from week 56 to week 82	0 umol/L Standard Deviation 5	-0 umol/L Standard Deviation 4

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP Creatinine kinase: Change from week 0 to week 30	13 U/L Standard Deviation 251	0 U/L Standard Deviation 225
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP Creatinine kinase: Change from week 0 to week 56	32 U/L Standard Deviation 228	0 U/L Standard Deviation 111
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP Creatinine kinase: Change from week 56 to week 82	28 U/L Standard Deviation 321	4 U/L Standard Deviation 114
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP Amylase: Change from week 0 to week 30	4 U/L Standard Deviation 12	3 U/L Standard Deviation 16
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP Amylase: Change from week 0 to week 56	2 U/L Standard Deviation 10	-0 U/L Standard Deviation 9
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP Amylase: Change from week 56 to week 82	-1 U/L Standard Deviation 8	1 U/L Standard Deviation 11
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP Lipase: Change from week 0 to week 30	6 U/L Standard Deviation 13	1 U/L Standard Deviation 19
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP Lipase: Change from week 0 to week 56	3 U/L Standard Deviation 13	-2 U/L Standard Deviation 5
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP Lipase: Change from week 56 to week 82	-4 U/L Standard Deviation 9	-0 U/L Standard Deviation 5
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP ALT: Change from week 0 to week 30	-2 U/L Standard Deviation 15	-1 U/L Standard Deviation 15
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP ALT: Change from week 0 to week 56	-2 U/L Standard Deviation 16	-0 U/L Standard Deviation 23
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP ALT: Change from week 56 to week 82	1 U/L Standard Deviation 12	2 U/L Standard Deviation 20
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP AST: Change from week 0 to week 30	-1 U/L Standard Deviation 8	-1 U/L Standard Deviation 11
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP AST: Change from week 0 to week 56	-1 U/L Standard Deviation 8	-1 U/L Standard Deviation 11
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP AST: Change from week 56 to week 82	1 U/L Standard Deviation 12	1 U/L Standard Deviation 11
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP ALP: Change from week 0 to week 30	-16 U/L Standard Deviation 25	-8 U/L Standard Deviation 66
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP ALP: Change from week 0 to week 56	-23 U/L Standard Deviation 36	-19 U/L Standard Deviation 53
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP ALP: Change from week 56 to week 82	-2 U/L Standard Deviation 22	-10 U/L Standard Deviation 24

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected Urea (BUN): Change from week 0 to week 30	-0.06 mmol/L Standard Deviation 1.07	0.00 mmol/L Standard Deviation 1.14
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected Urea (BUN): Change from week 0 to week 56	-0.26 mmol/L Standard Deviation 1.01	-0.05 mmol/L Standard Deviation 1.19
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected Urea (BUN): Change from week 56 to week 82	0.23 mmol/L Standard Deviation 1.11	0.00 mmol/L Standard Deviation 1.07
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected Sodium: Change from week 0 to week 30	0 mmol/L Standard Deviation 2	0 mmol/L Standard Deviation 2
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected Sodium: Change from week 0 to week 56	0 mmol/L Standard Deviation 2	0 mmol/L Standard Deviation 3
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected Sodium: Change from week 56 to week 82	-1 mmol/L Standard Deviation 3	-1 mmol/L Standard Deviation 3
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected Potassium: Change from week 0 to week 30	-0.0 mmol/L Standard Deviation 0.4	0.0 mmol/L Standard Deviation 0.3
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected Potassium: Change from week 0 to week 56	-0.1 mmol/L Standard Deviation 0.4	-0.0 mmol/L Standard Deviation 0.3
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected Potassium: Change from week 56 to week 82	0.0 mmol/L Standard Deviation 0.3	-0.0 mmol/L Standard Deviation 0.4
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected Calcium total: Change from week 0 to week 30	-0.01 mmol/L Standard Deviation 0.09	-0.03 mmol/L Standard Deviation 0.09
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected Calcium total: Change from week 0 to week 56	-0.04 mmol/L Standard Deviation 0.10	-0.04 mmol/L Standard Deviation 0.09
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected Calcium total: Change from week 56 to week 82	-0.00 mmol/L Standard Deviation 0.09	-0.01 mmol/L Standard Deviation 0.09
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected Ca albumin-corrected:Change from week 0 to week 30	-0.04 mmol/L Standard Deviation 0.09	-0.03 mmol/L Standard Deviation 0.09
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected Ca albumin-corrected:Change from week 0 to week 56	-0.07 mmol/L Standard Deviation 0.10	-0.07 mmol/L Standard Deviation 0.08
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected Ca albumin-corrected: Change from Wk 56 to Wk 82	0.01 mmol/L Standard Deviation 0.07	-0.00 mmol/L Standard Deviation 0.09

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Biochemistry: Albumin Change from week 0 to week 30	0.1 g/dL Standard Deviation 0.2	0.0 g/dL Standard Deviation 0.3
Change in Biochemistry: Albumin Change from week 0 to week 56	0.1 g/dL Standard Deviation 0.3	0.1 g/dL Standard Deviation 0.3
Change in Biochemistry: Albumin Change from week 56 to week 82	-0.0 g/dL Standard Deviation 0.2	-0.0 g/dL Standard Deviation 0.3

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Biochemistry: CEA Change from week 0 to week 30	-0.0 ng/mL Standard Deviation 0.3	-0.1 ng/mL Standard Deviation 0.6
Change in Biochemistry: CEA Change from week 0 to week 56	0.0 ng/mL Standard Deviation 0.4	-0.0 ng/mL Standard Deviation 0.6
Change in Biochemistry: CEA Change from week 56 to week 82	0.0 ng/mL Standard Deviation 0.4	0.0 ng/mL Standard Deviation 0.3

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Hormone Level: Calcitonin Change from week 56 to week 82	-0.1 ng/L Standard Deviation 0.6	0.2 ng/L Standard Deviation 1.5
Change in Hormone Level: Calcitonin Change from week 0 to week 30	0.1 ng/L Standard Deviation 0.8	0.1 ng/L Standard Deviation 0.7
Change in Hormone Level: Calcitonin Change from week 0 to week 56	0.0 ng/L Standard Deviation 0.7	-0.0 ng/L Standard Deviation 0.8

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Hormone Level: TSH and Prolactin Prolactin: Change from week 56 to week 82	-29 mIU/L Standard Deviation 396	13 mIU/L Standard Deviation 98
Change in Hormone Level: TSH and Prolactin TSH: Change from week 0 to week 30	-0.35 mIU/L Standard Deviation 1.37	-0.08 mIU/L Standard Deviation 1.17
Change in Hormone Level: TSH and Prolactin TSH: Change from week 0 to week 56	-0.42 mIU/L Standard Deviation 1.36	-0.14 mIU/L Standard Deviation 1.28
Change in Hormone Level: TSH and Prolactin TSH: Change from week 56 to week 82	0.38 mIU/L Standard Deviation 1.91	0.13 mIU/L Standard Deviation 1.57
Change in Hormone Level: TSH and Prolactin Prolactin: Change from week 0 to week 30	23 mIU/L Standard Deviation 165	-47 mIU/L Standard Deviation 452
Change in Hormone Level: TSH and Prolactin Prolactin: Change from week 0 to week 56	63 mIU/L Standard Deviation 312	-63 mIU/L Standard Deviation 684

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Hormone Level: Free T4 and ACTH T4: Change from week 0 to week 30	0.6 pmol/L Standard Deviation 1.9	0.8 pmol/L Standard Deviation 2.1
Change in Hormone Level: Free T4 and ACTH T4: Change from week 0 to week 56	0.3 pmol/L Standard Deviation 1.8	0.6 pmol/L Standard Deviation 2.1
Change in Hormone Level: Free T4 and ACTH T4: Change from week 56 to week 82	0.0 pmol/L Standard Deviation 1.6	0.2 pmol/L Standard Deviation 2.3
Change in Hormone Level: Free T4 and ACTH ACTH: Change from week 0 to week 30	0.4 pmol/L Standard Deviation 4.4	0.5 pmol/L Standard Deviation 3.9
Change in Hormone Level: Free T4 and ACTH ACTH: Change from week 0 to week 56	0.6 pmol/L Standard Deviation 4.9	0.6 pmol/L Standard Deviation 3.8
Change in Hormone Level: Free T4 and ACTH ACTH: Change from week 56 to week 82	-0.8 pmol/L Standard Deviation 4.7	-0.4 pmol/L Standard Deviation 2.9

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Hormone Level: IGF-1 and Cortisol IGF-1: Change from week 0 to week 30	10.61 ng/mL Standard Deviation 89.83	3.79 ng/mL Standard Deviation 101.12
Change in Hormone Level: IGF-1 and Cortisol IGF-1: Change from week 0 to week 56	-4.60 ng/mL Standard Deviation 84.51	3.69 ng/mL Standard Deviation 111.63
Change in Hormone Level: IGF-1 and Cortisol IGF-1: Change from week 56 to week 82	-14.60 ng/mL Standard Deviation 80.82	-16.35 ng/mL Standard Deviation 65.89
Change in Hormone Level: IGF-1 and Cortisol Cortisol: Change from week 0 to week 30	6.9 ng/mL Standard Deviation 66.9	8.6 ng/mL Standard Deviation 60.1
Change in Hormone Level: IGF-1 and Cortisol Cortisol: Change from week 0 to week 56	5.1 ng/mL Standard Deviation 65.2	8.5 ng/mL Standard Deviation 57.9
Change in Hormone Level: IGF-1 and Cortisol Cortisol: Change from week 56 to week 82	0.6 ng/mL Standard Deviation 66.6	10.4 ng/mL Standard Deviation 61.2

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Hormone Level: DHEAS Change from week 0 to week 30	0.94 umol/L Standard Deviation 1.66	0.57 umol/L Standard Deviation 1.78
Change in Hormone Level: DHEAS Change from week 0 to week 56	0.95 umol/L Standard Deviation 1.91	0.89 umol/L Standard Deviation 2.05
Change in Hormone Level: DHEAS Change from week 56 to week 82	-0.08 umol/L Standard Deviation 2.11	-0.05 umol/L Standard Deviation 1.27

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Hormone Level: LH and FSH LH: Change from week 0 to week 30	0.4 IU/L Standard Deviation 9.1	0.7 IU/L Standard Deviation 7.9
Change in Hormone Level: LH and FSH LH: Change from week 0 to week 56	0.2 IU/L Standard Deviation 9.1	0.6 IU/L Standard Deviation 6.6
Change in Hormone Level: LH and FSH LH: Change from week 56 to week 82	0.4 IU/L Standard Deviation 8.7	-0.5 IU/L Standard Deviation 8.0
Change in Hormone Level: LH and FSH FSH: Change from week 0 to week 30	0.2 IU/L Standard Deviation 2.6	-0.2 IU/L Standard Deviation 2.7
Change in Hormone Level: LH and FSH FSH: Change from week 0 to week 56	0.6 IU/L Standard Deviation 4.0	0.1 IU/L Standard Deviation 2.5
Change in Hormone Level: LH and FSH FSH: Change from week 56 to week 82	-0.1 IU/L Standard Deviation 3.6	-0.1 IU/L Standard Deviation 3.1

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=71 Participants 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.	Placebo n=78 Participants 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.
Change in Hormone Level: Estradiol (Females) Change from week 0 to week 30	-5.0 pg/mL Standard Deviation 81.0	20.2 pg/mL Standard Deviation 67.6
Change in Hormone Level: Estradiol (Females) Change from week 0 to week 56	11.6 pg/mL Standard Deviation 94.4	14.1 pg/mL Standard Deviation 63.6
Change in Hormone Level: Estradiol (Females) Change from week 56 to week 82	-2.3 pg/mL Standard Deviation 89.1	-1.7 pg/mL Standard Deviation 65.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=54 Participants 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.	Placebo n=48 Participants 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.
Change in Hormone Level: Testosterone (Males) Week 0	8.13 nmol/L Standard Deviation 3.45	8.06 nmol/L Standard Deviation 3.66
Change in Hormone Level: Testosterone (Males) Week 30	10.00 nmol/L Standard Deviation 4.02	9.33 nmol/L Standard Deviation 5.27
Change in Hormone Level: Testosterone (Males) Week 56	10.55 nmol/L Standard Deviation 4.14	9.51 nmol/L Standard Deviation 3.31
Change in Hormone Level: Testosterone (Males) Week 82	11.36 nmol/L Standard Deviation 5.27	6.16 nmol/L Standard Deviation 3.27

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in NTX1 Change from week 0 to week 30	-2.4 nmol BCE/L Standard Deviation 10.4	-3.2 nmol BCE/L Standard Deviation 12.0
Change in NTX1 Change from week 0 to week 56	-3.7 nmol BCE/L Standard Deviation 14.1	-2.9 nmol BCE/L Standard Deviation 15.1
Change in NTX1 Change from week 56 to week 82	-2.8 nmol BCE/L Standard Deviation 12.8	-4.6 nmol BCE/L Standard Deviation 10.0

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in CTX1 Change from week 0 to week 30	-7 pg/mL Standard Deviation 358	-84 pg/mL Standard Deviation 404
Change in CTX1 Change from week 0 to week 56	-36 pg/mL Standard Deviation 353	-97 pg/mL Standard Deviation 473
Change in CTX1 Change from week 56 to week 82	-107 pg/mL Standard Deviation 359	-162 pg/mL Standard Deviation 318

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in P1NP Change from week 0 to week 30	-35 ng/mL Standard Deviation 124	-30 ng/mL Standard Deviation 184
Change in P1NP Change from week 0 to week 56	-55 ng/mL Standard Deviation 151	-63 ng/mL Standard Deviation 192
Change in P1NP Change from week 56 to week 82	-30 ng/mL Standard Deviation 107	-47 ng/mL Standard Deviation 84

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Alkaline Phosphatase (Bone) Change from week 0 to week 30	-15 U/L Standard Deviation 16	-12 U/L Standard Deviation 26
Change in Alkaline Phosphatase (Bone) Change from week 0 to week 56	-17 U/L Standard Deviation 18	-17 U/L Standard Deviation 30
Change in Alkaline Phosphatase (Bone) Change from week 56 to week 82	-1 U/L Standard Deviation 11	-4 U/L Standard Deviation 12

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Pubertal Status Week 82: penis development (male) · Stage 3	3 Participants	3 Participants
Change in Pubertal Status Week 82: penis development (male) · Stage 4	11 Participants	6 Participants
Change in Pubertal Status Week 82: penis development (male) · Stage 5	31 Participants	29 Participants
Change in Pubertal Status Week 0: Pubic hair development (male) · Stage 2	6 Participants	9 Participants
Change in Pubertal Status Week 0: Pubic hair development (male) · Stage 3	8 Participants	5 Participants
Change in Pubertal Status Week 0: Pubic hair development (male) · Stage 4	19 Participants	13 Participants
Change in Pubertal Status Week 0: Pubic hair development (male) · Stage 5	21 Participants	21 Participants
Change in Pubertal Status Week 30: Pubic hair development (male) · Stage 2	1 Participants	3 Participants
Change in Pubertal Status Week 30: Pubic hair development (male) · Stage 3	10 Participants	7 Participants
Change in Pubertal Status Week 30: Pubic hair development (male) · Stage 4	15 Participants	9 Participants
Change in Pubertal Status Week 30: Pubic hair development (male) · Stage 5	24 Participants	26 Participants
Change in Pubertal Status Week 56: Pubic hair development (male) · Stage 2	1 Participants	0 Participants
Change in Pubertal Status Week 56: Pubic hair development (male) · Stage 3	7 Participants	6 Participants
Change in Pubertal Status Week 56: Pubic hair development (male) · Stage 4	15 Participants	7 Participants
Change in Pubertal Status Week 56: Pubic hair development (male) · Stage 5	24 Participants	28 Participants
Change in Pubertal Status Week 82: Pubic hair development (male) · Stage 2	0 Participants	0 Participants
Change in Pubertal Status Week 82: Pubic hair development (male) · Stage 3	3 Participants	2 Participants
Change in Pubertal Status Week 82: Pubic hair development (male) · Stage 4	10 Participants	8 Participants
Change in Pubertal Status Week 82: Pubic hair development (male) · Stage 5	30 Participants	28 Participants
Change in Pubertal Status Week 0: Breast development (for female) · Stage 2	2 Participants	1 Participants
Change in Pubertal Status Week 0: Breast development (for female) · Stage 3	6 Participants	8 Participants
Change in Pubertal Status Week 0: Breast development (for female) · Stage 4	23 Participants	30 Participants
Change in Pubertal Status Week 0: Breast development (for female) · Stage 5	40 Participants	39 Participants
Change in Pubertal Status Week 30: Breast development (for female) · Stage 2	1 Participants	0 Participants
Change in Pubertal Status Week 30: Breast development (for female) · Stage 3	4 Participants	6 Participants
Change in Pubertal Status Week 30: Breast development (for female) · Stage 4	22 Participants	25 Participants
Change in Pubertal Status Week 30: Breast development (for female) · Stage 5	39 Participants	43 Participants
Change in Pubertal Status Week 56: Breast development (for female) · Stage 2	0 Participants	0 Participants
Change in Pubertal Status Week 56: Breast development (for female) · Stage 3	2 Participants	2 Participants
Change in Pubertal Status Week 56: Breast development (for female) · Stage 4	14 Participants	20 Participants
Change in Pubertal Status Week 56: Breast development (for female) · Stage 5	41 Participants	41 Participants
Change in Pubertal Status Week 82: Breast development (for female) · Stage 2	0 Participants	0 Participants
Change in Pubertal Status Week 82: Breast development (for female) · Stage 3	0 Participants	2 Participants
Change in Pubertal Status Week 82: Breast development (for female) · Stage 4	7 Participants	13 Participants
Change in Pubertal Status Week 82: Breast development (for female) · Stage 5	46 Participants	46 Participants
Change in Pubertal Status Week 0: Pubic hair development (for female) · Stage 2	2 Participants	3 Participants
Change in Pubertal Status Week 0: Pubic hair development (for female) · Stage 3	6 Participants	5 Participants
Change in Pubertal Status Week 0: Pubic hair development (for female) · Stage 4	22 Participants	26 Participants
Change in Pubertal Status Week 0: Pubic hair development (for female) · Stage 5	41 Participants	44 Participants
Change in Pubertal Status Week 30: Pubic hair development (for female) · Stage 2	1 Participants	0 Participants
Change in Pubertal Status Week 30: Pubic hair development (for female) · Stage 3	4 Participants	4 Participants
Change in Pubertal Status Week 30: Pubic hair development (for female) · Stage 4	20 Participants	25 Participants
Change in Pubertal Status Week 30: Pubic hair development (for female) · Stage 5	41 Participants	45 Participants
Change in Pubertal Status Week 56: Pubic hair development (for female) · Stage 2	1 Participants	0 Participants
Change in Pubertal Status Week 56: Pubic hair development (for female) · Stage 3	2 Participants	2 Participants
Change in Pubertal Status Week 56: Pubic hair development (for female) · Stage 4	13 Participants	21 Participants
Change in Pubertal Status Week 56: Pubic hair development (for female) · Stage 5	41 Participants	40 Participants
Change in Pubertal Status Week 82: Pubic hair development (for female) · Stage 2	0 Participants	0 Participants
Change in Pubertal Status Week 82: Pubic hair development (for female) · Stage 3	1 Participants	2 Participants
Change in Pubertal Status Week 82: Pubic hair development (for female) · Stage 4	7 Participants	14 Participants
Change in Pubertal Status Week 82: Pubic hair development (for female) · Stage 5	45 Participants	45 Participants
Change in Pubertal Status Week 0: penis development (male) · Stage 2	4 Participants	7 Participants
Change in Pubertal Status Week 0: penis development (male) · Stage 3	11 Participants	8 Participants
Change in Pubertal Status Week 0: penis development (male) · Stage 4	16 Participants	14 Participants
Change in Pubertal Status Week 0: penis development (male) · Stage 5	23 Participants	19 Participants
Change in Pubertal Status Week 30: penis development (male) · Stage 2	1 Participants	2 Participants
Change in Pubertal Status Week 30: penis development (male) · Stage 3	11 Participants	7 Participants
Change in Pubertal Status Week 30: penis development (male) · Stage 4	14 Participants	11 Participants
Change in Pubertal Status Week 30: penis development (male) · Stage 5	25 Participants	25 Participants
Change in Pubertal Status Week 56: penis development (male) · Stage 2	1 Participants	0 Participants
Change in Pubertal Status Week 56: penis development (male) · Stage 3	6 Participants	6 Participants
Change in Pubertal Status Week 56: penis development (male) · Stage 4	15 Participants	6 Participants
Change in Pubertal Status Week 56: penis development (male) · Stage 5	26 Participants	29 Participants
Change in Pubertal Status Week 82: penis development (male) · Stage 2	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Physical Examination General Appearance: Week 0 · Normal	93 Participants	101 Participants
Change in Physical Examination Head, ears, eyes, nose, throat, neck: Week 56 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination General Appearance: Week 0 · Abnormal, NCS	30 Participants	23 Participants
Change in Physical Examination General Appearance: Week 0 · Abnormal, CS	2 Participants	2 Participants
Change in Physical Examination General Appearance: Week 30 · Normal	94 Participants	95 Participants
Change in Physical Examination General Appearance: Week 30 · Abnormal, NCS	21 Participants	20 Participants
Change in Physical Examination General Appearance: Week 30 · Abnormal, CS	1 Participants	1 Participants
Change in Physical Examination General Appearance: Week 56 · Normal	84 Participants	85 Participants
Change in Physical Examination General Appearance: Week 56 · Abnormal, NCS	18 Participants	16 Participants
Change in Physical Examination General Appearance: Week 56 · Abnormal, CS	2 Participants	1 Participants
Change in Physical Examination General Appearance: Week 82 · Normal	80 Participants	81 Participants
Change in Physical Examination General Appearance: Week 82 · Abnormal, NCS	18 Participants	17 Participants
Change in Physical Examination General Appearance: Week 82 · Abnormal, CS	1 Participants	1 Participants
Change in Physical Examination Head, ears, eyes, nose, throat, neck: Week 0 · Normal	120 Participants	116 Participants
Change in Physical Examination Head, ears, eyes, nose, throat, neck: Week 0 · Abnormal, NCS	5 Participants	10 Participants
Change in Physical Examination Head, ears, eyes, nose, throat, neck: Week 0 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Head, ears, eyes, nose, throat, neck: Week 30 · Normal	114 Participants	107 Participants
Change in Physical Examination Head, ears, eyes, nose, throat, neck: Week 30 · Abnormal, NCS	2 Participants	9 Participants
Change in Physical Examination Head, ears, eyes, nose, throat, neck: Week 30 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Head, ears, eyes, nose, throat, neck: Week 56 · Normal	101 Participants	98 Participants
Change in Physical Examination Head, ears, eyes, nose, throat, neck: Week 56 · Abnormal, NCS	3 Participants	4 Participants
Change in Physical Examination Head, ears, eyes, nose, throat, neck: Week 82 · Normal	98 Participants	94 Participants
Change in Physical Examination Head, ears, eyes, nose, throat, neck: Week 82 · Abnormal, NCS	1 Participants	5 Participants
Change in Physical Examination Cardiovascular system: Week 30 · Normal	115 Participants	112 Participants
Change in Physical Examination Head, ears, eyes, nose, throat, neck: Week 82 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Respiratory system: Week 0 · Normal	125 Participants	123 Participants
Change in Physical Examination Respiratory system: Week 0 · Abnormal, NCS	0 Participants	3 Participants
Change in Physical Examination Respiratory system: Week 0 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Respiratory system: Week 30 · Normal	116 Participants	115 Participants
Change in Physical Examination Respiratory system: Week 30 · Abnormal, NCS	0 Participants	1 Participants
Change in Physical Examination Respiratory system: Week 30 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Respiratory system: Week 56 · Normal	104 Participants	101 Participants
Change in Physical Examination Respiratory system: Week 56 · Abnormal, NCS	0 Participants	1 Participants
Change in Physical Examination Respiratory system: Week 56 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Respiratory system: Week 82 · Normal	99 Participants	96 Participants
Change in Physical Examination Respiratory system: Week 82 · Abnormal, NCS	0 Participants	3 Participants
Change in Physical Examination Respiratory system: Week 82 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Cardiovascular system: Week 30 · Abnormal, NCS	1 Participants	4 Participants
Change in Physical Examination Cardiovascular system: Week 0 · Normal	124 Participants	125 Participants
Change in Physical Examination Cardiovascular system: Week 0 · Abnormal, NCS	1 Participants	1 Participants
Change in Physical Examination Cardiovascular system: Week 0 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Cardiovascular system: Week 30 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Cardiovascular system: Week 56 · Normal	102 Participants	100 Participants
Change in Physical Examination Cardiovascular system: Week 56 · Abnormal, NCS	2 Participants	2 Participants
Change in Physical Examination Cardiovascular system: Week 56 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Cardiovascular system: Week 82 · Normal	97 Participants	98 Participants
Change in Physical Examination Cardiovascular system: Week 82 · Abnormal, NCS	2 Participants	1 Participants
Change in Physical Examination Cardiovascular system: Week 82 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination GI system including mouth: Week 0 · Normal	119 Participants	119 Participants
Change in Physical Examination GI system including mouth: Week 0 · Abnormal, NCS	5 Participants	6 Participants
Change in Physical Examination GI system including mouth: Week 0 · Abnormal, CS	1 Participants	1 Participants
Change in Physical Examination GI system including mouth: Week 30 · Normal	111 Participants	109 Participants
Change in Physical Examination GI system including mouth: Week 30 · Abnormal, NCS	5 Participants	6 Participants
Change in Physical Examination GI system including mouth: Week 30 · Abnormal, CS	0 Participants	1 Participants
Change in Physical Examination GI system including mouth: Week 56 · Normal	102 Participants	98 Participants
Change in Physical Examination GI system including mouth: Week 56 · Abnormal, NCS	2 Participants	4 Participants
Change in Physical Examination GI system including mouth: Week 56 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination GI system including mouth: Week 82 · Normal	96 Participants	94 Participants
Change in Physical Examination GI system including mouth: Week 82 · Abnormal, NCS	1 Participants	5 Participants
Change in Physical Examination GI system including mouth: Week 82 · Abnormal, CS	2 Participants	0 Participants
Change in Physical Examination Musculoskeletal system: Week 0 · Normal	121 Participants	119 Participants
Change in Physical Examination Musculoskeletal system: Week 0 · Abnormal, NCS	4 Participants	7 Participants
Change in Physical Examination Musculoskeletal system: Week 0 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Musculoskeletal system: Week 30 · Normal	113 Participants	106 Participants
Change in Physical Examination Musculoskeletal system: Week 30 · Abnormal, NCS	3 Participants	10 Participants
Change in Physical Examination Musculoskeletal system: Week 30 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Musculoskeletal system: Week 56 · Normal	102 Participants	97 Participants
Change in Physical Examination Musculoskeletal system: Week 56 · Abnormal, NCS	1 Participants	5 Participants
Change in Physical Examination Musculoskeletal system: Week 56 · Abnormal, CS	1 Participants	0 Participants
Change in Physical Examination Musculoskeletal system: Week 82 · Normal	97 Participants	92 Participants
Change in Physical Examination Musculoskeletal system: Week 82 · Abnormal, NCS	1 Participants	7 Participants
Change in Physical Examination Musculoskeletal system: Week 82 · Abnormal, CS	1 Participants	0 Participants
Change in Physical Examination CNS and PNS: Week 0 · Normal	124 Participants	124 Participants
Change in Physical Examination CNS and PNS: Week 0 · Abnormal, NCS	1 Participants	2 Participants
Change in Physical Examination CNS and PNS: Week 0 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination CNS and PNS: Week 30 · Normal	115 Participants	115 Participants
Change in Physical Examination CNS and PNS: Week 30 · Abnormal, NCS	1 Participants	1 Participants
Change in Physical Examination CNS and PNS: Week 30 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination CNS and PNS: Week 56 · Normal	104 Participants	101 Participants
Change in Physical Examination CNS and PNS: Week 56 · Abnormal, NCS	0 Participants	1 Participants
Change in Physical Examination CNS and PNS: Week 56 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination CNS and PNS: Week 82 · Normal	99 Participants	98 Participants
Change in Physical Examination CNS and PNS: Week 82 · Abnormal, NCS	0 Participants	1 Participants
Change in Physical Examination CNS and PNS: Week 82 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Skin: Week 0 · Normal	76 Participants	58 Participants
Change in Physical Examination Skin: Week 0 · Abnormal, NCS	47 Participants	64 Participants
Change in Physical Examination Skin: Week 0 · Abnormal, CS	2 Participants	4 Participants
Change in Physical Examination Skin: Week 30 · Normal	71 Participants	56 Participants
Change in Physical Examination Skin: Week 30 · Abnormal, NCS	44 Participants	56 Participants
Change in Physical Examination Skin: Week 30 · Abnormal, CS	1 Participants	4 Participants
Change in Physical Examination Skin: Week 56 · Normal	65 Participants	48 Participants
Change in Physical Examination Skin: Week 56 · Abnormal, NCS	35 Participants	53 Participants
Change in Physical Examination Skin: Week 56 · Abnormal, CS	4 Participants	1 Participants
Change in Physical Examination Skin: Week 82 · Normal	57 Participants	50 Participants
Change in Physical Examination Skin: Week 82 · Abnormal, NCS	40 Participants	48 Participants
Change in Physical Examination Skin: Week 82 · Abnormal, CS	2 Participants	1 Participants
Change in Physical Examination Thyroid gland: Week 0 · Normal	124 Participants	124 Participants
Change in Physical Examination Thyroid gland: Week 0 · Abnormal, NCS	1 Participants	2 Participants
Change in Physical Examination Thyroid gland: Week 0 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Thyroid gland: Week 30 · Normal	115 Participants	114 Participants
Change in Physical Examination Thyroid gland: Week 30 · Abnormal, NCS	1 Participants	2 Participants
Change in Physical Examination Thyroid gland: Week 30 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Thyroid gland: Week 56 · Normal	103 Participants	101 Participants
Change in Physical Examination Thyroid gland: Week 56 · Abnormal, NCS	1 Participants	1 Participants
Change in Physical Examination Thyroid gland: Week 56 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Thyroid gland: Week 82 · Normal	97 Participants	98 Participants
Change in Physical Examination Thyroid gland: Week 82 · Abnormal, NCS	2 Participants	1 Participants
Change in Physical Examination Thyroid gland: Week 82 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Lymph node palpation: Week 0 · Normal	124 Participants	125 Participants
Change in Physical Examination Lymph node palpation: Week 0 · Abnormal, NCS	1 Participants	1 Participants
Change in Physical Examination Lymph node palpation: Week 0 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Lymph node palpation: Week 30 · Normal	115 Participants	116 Participants
Change in Physical Examination Lymph node palpation: Week 30 · Abnormal, NCS	1 Participants	0 Participants
Change in Physical Examination Lymph node palpation: Week 30 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Lymph node palpation: Week 56 · Normal	103 Participants	102 Participants
Change in Physical Examination Lymph node palpation: Week 56 · Abnormal, NCS	1 Participants	0 Participants
Change in Physical Examination Lymph node palpation: Week 56 · Abnormal, CS	0 Participants	0 Participants
Change in Physical Examination Lymph node palpation: Week 82 · Normal	98 Participants	98 Participants
Change in Physical Examination Lymph node palpation: Week 82 · Abnormal, NCS	1 Participants	1 Participants
Change in Physical Examination Lymph node palpation: Week 82 · Abnormal, CS	0 Participants	0 Participants

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in Height SDS Change from week 0 to week 30	0.11 SDS Standard Deviation 0.17	0.13 SDS Standard Deviation 0.18
Change in Height SDS Change from week 0 to week 56	0.20 SDS Standard Deviation 0.27	0.24 SDS Standard Deviation 0.30
Change in Height SDS Change from week 56 to week 82	0.07 SDS Standard Deviation 0.16	0.06 SDS Standard Deviation 0.12

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in C-SSRS Wk 0: Suicidal ideation	2 Participants	2 Participants
Change in C-SSRS Wk 0: Suicidal behaviour	0 Participants	1 Participants
Change in C-SSRS Wk0: Self-injurious behaviour, no suicidal intent	0 Participants	1 Participants
Change in C-SSRS Wk 30: Suicidal ideation	0 Participants	0 Participants
Change in C-SSRS Wk 30: Suicidal behaviour	0 Participants	0 Participants
Change in C-SSRS Wk30: Self-injurious behaviour, no suicidal intent	0 Participants	0 Participants
Change in C-SSRS Wk 56: Suicidal ideation	0 Participants	0 Participants
Change in C-SSRS Wk 56: Suicidal behaviour	0 Participants	0 Participants
Change in C-SSRS Wk56: Self-injurious behaviour, no suicidal intent	0 Participants	0 Participants
Change in C-SSRS Wk 82: Suicidal ideation	0 Participants	0 Participants
Change in C-SSRS Wk 82: Suicidal behaviour	0 Participants	0 Participants
Change in C-SSRS Wk82: Self-injurious behaviour, no suicidal intent	0 Participants	0 Participants

SECONDARY outcome

Timeframe: (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.

Outcome measures

Outcome measures
Measure	Liraglutide 3.0 mg n=125 Participants 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.	Placebo n=126 Participants 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.
Change in PHQ-9 Change from week 0 to week 30	-1 Score on a scale Standard Deviation 4	-1 Score on a scale Standard Deviation 4
Change in PHQ-9 Change from week 0 to week 56	-1 Score on a scale Standard Deviation 3	-2 Score on a scale Standard Deviation 3
Change in PHQ-9 Change from week 56 to week 82	0 Score on a scale Standard Deviation 2	-0 Score on a scale Standard Deviation 3

Adverse Events

Liraglutide 3.0 mg

Serious events: 3 serious events

Other events: 100 other events

Deaths: 1 deaths

Placebo

Serious events: 5 serious events

Other events: 84 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Liraglutide 3.0 mg n=125 participants at risk 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.	Placebo n=126 participants at risk 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.
Infections and infestations Appendicitis	0.00% 0/125 • 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. 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).	0.79% 1/126 • Number of events 1 • 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. 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).
Hepatobiliary disorders Cholecystitis acute	0.00% 0/125 • 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. 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).	0.79% 1/126 • Number of events 1 • 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. 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).
Hepatobiliary disorders Cholelithiasis	0.00% 0/125 • 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. 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).	0.79% 1/126 • Number of events 1 • 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. 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).
Psychiatric disorders Completed suicide	0.80% 1/125 • Number of events 1 • 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. 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).	0.00% 0/126 • 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. 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).
Reproductive system and breast disorders Haemorrhagic ovarian cyst	0.00% 0/125 • 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. 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).	0.79% 1/126 • Number of events 1 • 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. 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).
Musculoskeletal and connective tissue disorders Myositis	0.80% 1/125 • Number of events 1 • 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. 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).	0.00% 0/126 • 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. 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).
Infections and infestations Pneumonia	0.00% 0/125 • 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. 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).	0.79% 1/126 • Number of events 1 • 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. 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).
Injury, poisoning and procedural complications Post procedural haemorrhage	0.80% 1/125 • Number of events 1 • 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. 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).	0.00% 0/126 • 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. 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).
Vascular disorders Thrombophlebitis	0.00% 0/125 • 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. 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).	0.79% 1/126 • Number of events 1 • 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. 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).

Other adverse events

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER