Trial Outcomes & Findings for Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting (NCT NCT02963935)

NCT ID: NCT02963935

Last Updated: 2020-03-11

Results Overview

Observed mean change in body weight from baseline (week 0) to week 56 was evaluated for two different observation periods. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which subjects are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). The test of superiority of liraglutide to placebo for the treatment policy estimand was tested in a hierarchical manner for the two primary and the consequent 7 confirmatory secondary endpoints presented.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 282 participants
• Primary outcome timeframe: Week 0, week 56
• Results posted on: 2020-03-11

Participant Flow

The trial was conducted at 17 sites in the United States.

All the subjects received Intensive Behaviour Therapy (IBT) for obesity in a primary care setting according to Centers for Medicare & Medicaid Services (CMS) visit schedule during the trial.

Participant milestones

Measure	Liraglutide 3.0 mg Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Study STARTED	142	140
Overall Study COMPLETED	114	103
Overall Study NOT COMPLETED	28	37

Reasons for withdrawal

Measure	Liraglutide 3.0 mg Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Study Adverse Event	12	6
Overall Study Protocol Violation	2	1
Overall Study Lack of Efficacy	0	2
Overall Study Lost to Follow-up	1	6
Overall Study Unclassified	13	22

Baseline Characteristics

Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting

Baseline characteristics by cohort

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.	Total n=282 Participants Total of all reporting groups
Age, Continuous	45.4 Years STANDARD_DEVIATION 11.6 • n=5 Participants	49 Years STANDARD_DEVIATION 11.2 • n=7 Participants	47.2 Years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	119 Participants n=5 Participants	116 Participants n=7 Participants	235 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) White	112 Participants n=5 Participants	115 Participants n=7 Participants	227 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body weight	108.5 kg STANDARD_DEVIATION 22.1 • n=5 Participants	106.7 kg STANDARD_DEVIATION 22.0 • n=7 Participants	107.6 kg STANDARD_DEVIATION 22.0 • n=5 Participants

PRIMARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change in body weight from baseline (week 0) to week 56 was evaluated for two different observation periods. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which subjects are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).

The test of superiority of liraglutide to placebo for the treatment policy estimand was tested in a hierarchical manner for the two primary and the consequent 7 confirmatory secondary endpoints presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Body Weight (%) In-trial observation period	-7.4 percent change Standard Deviation 7.9	-4.0 percent change Standard Deviation 7.4
Change in Body Weight (%) On-drug observation period	-9.1 percent change Standard Deviation 7.4	-4.8 percent change Standard Deviation 7.6

PRIMARY outcome

Timeframe: Week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

The estimated mean percentage of subjects losing at least 5% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56 On-drug observation period	64.08 percentage of participants	38.57 percentage of participants
Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56 In-trial observation period	61.47 percentage of participants	38.82 percentage of participants

SECONDARY outcome

Timeframe: Week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

The estimated mean percentage of subjects losing more than 10% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56 In-trial observation period	30.45 percentage of participants	19.75 percentage of participants
Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56 On-drug observation period	33.80 percentage of participants	19.29 percentage of participants

SECONDARY outcome

Timeframe: Week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

The estimated mean percentage of subjects losing more than 15% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56 In-trial observation period	18.11 percentage of participants	8.92 percentage of participants
Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56 On-drug observation period	20.42 percentage of participants	8.57 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

The estimated mean percentage of subjects losing 4% or more of baseline body weight at week 16 is presented. The endpoint was evaluated for treatment policy estimand (in-trial data).

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Proportion of Subjects Losing 4% or More of Baseline Body Weight	78.73 percentage of participants	52.70 percentage of participants

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change from baseline in waist circumference. The endpoint was evaluated based on in-trial data and on-drug data.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Waist Circumference (cm) In-trial observation period	-9.27 cm Standard Deviation 9.22	-6.91 cm Standard Deviation 8.22
Change in Waist Circumference (cm) On-drug observation period	-10.46 cm Standard Deviation 9.22	-7.24 cm Standard Deviation 8.67

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

SF-36 is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL).

SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 physical functioning score is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score In-trial observation period	3.55 Scores on a scale Standard Deviation 6.98	4.21 Scores on a scale Standard Deviation 6.85
Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score On-drug observation period	4.03 Scores on a scale Standard Deviation 6.49	4.77 Scores on a scale Standard Deviation 6.03

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trials Version (IWQoL-Lite for CT ) score. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life.

The endpoint was evaluated based on in-trial data and on-drug data.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score In-trial observation period	13.5 Scores on a scale Standard Deviation 21.4	15.5 Scores on a scale Standard Deviation 23.0
Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score On-drug observation period	15.2 Scores on a scale Standard Deviation 21.4	17.5 Scores on a scale Standard Deviation 21.4

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change from baseline in 6 minutes walking distance test. The 6MWT is a common test of functional exercise capacity that assesses the distance a subject can walk in 6 minutes. The endpoint was evaluated based on in-trial data and on-drug data.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Six Minutes Walking Distance Test (6MWT) In-trial observation period	47 meter Standard Deviation 59	49 meter Standard Deviation 69
Change in Six Minutes Walking Distance Test (6MWT) On-drug observation period	53 meter Standard Deviation 61	51 meter Standard Deviation 69

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change from baseline to week 56 in glycosylated haemoglobin (HbA1c). Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change From Baseline in HbA1c (%)	-0.2 percentage Standard Deviation 0.3	-0.1 percentage Standard Deviation 0.2

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change from baseline (week 0) in fasting plasma glucose (FPG). Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change From Baseline in FPG (mg/dL)	-4.04 mg/dL Standard Deviation 9.59	-0.28 mg/dL Standard Deviation 11.46

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change in systolic blood pressure from baseline to week 56.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change From Baseline sBP (mmHg)	-2 mmHg Standard Deviation 14	-1 mmHg Standard Deviation 13

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change from baseline (week 0) to week 56 in diastolic blood pressure (dBP). Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change From Baseline dBP (mmHg)	-1 mmHg Standard Deviation 11	-1 mmHg Standard Deviation 10

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change from baseline (week 0) to week 56 in total cholesterol (TC). Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change From Baseline in Lipids -Total Cholesterol	-0.01 mmol/L Standard Deviation 0.59	0.00 mmol/L Standard Deviation 0.77

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change from baseline in low density cholesterol (LDL) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change From Baseline in Lipids - LDL Cholesterol	-0.01 mmol/L Standard Deviation 0.52	-0.01 mmol/L Standard Deviation 0.64

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change from baseline in high density (HDL) cholesterol from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change From Baseline in Lipids - HDL Cholesterol	0.06 mmol/L Standard Deviation 0.19	0.02 mmol/L Standard Deviation 0.22

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change from baseline in very low density cholesterol (VLDL) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change From Baseline in Lipids - VLDL Cholesterol	-0.06 mmol/L Standard Deviation 0.31	-0.01 mmol/L Standard Deviation 0.26

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change from baseline in triglyceride (TG) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change From Baseline in Lipids - TG	-0.19 mmol/L Standard Deviation 1.04	-0.01 mmol/L Standard Deviation 0.58

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change from baseline in free fatty acids (FFA) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change From Baseline in Lipids - FFA	-0.07 mmol/L Standard Deviation 0.28	-0.06 mmol/L Standard Deviation 0.31

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

SF-36 is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL).

SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in in the sub-domain scores is presented. A positive change score indicates an improvement since baseline. Results are evaluated based on in-trial data.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains) Bodily Pain	0.67 scores on a scale Standard Deviation 7.61	1.21 scores on a scale Standard Deviation 8.88
Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains) General Health Perception	1.89 scores on a scale Standard Deviation 6.31	1.08 scores on a scale Standard Deviation 6.62
Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains) Mental Health	-0.93 scores on a scale Standard Deviation 7.80	-0.68 scores on a scale Standard Deviation 6.89
Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains) Role Lim Emotion Prob	-1.27 scores on a scale Standard Deviation 7.72	-2.21 scores on a scale Standard Deviation 8.59
Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains) Role Lim. Phy Health	2.01 scores on a scale Standard Deviation 6.55	2.11 scores on a scale Standard Deviation 7.68
Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains) Social Functioning	1.22 scores on a scale Standard Deviation 8.69	-0.45 scores on a scale Standard Deviation 9.61
Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains) Vitality	2.64 scores on a scale Standard Deviation 8.99	2.43 scores on a scale Standard Deviation 7.78

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change from baseline (week 0) to week 56 in short form 36 v2.0 acute domain physical component summary (PCS). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 physical component summary (PCS) score is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Short Form-36 v2.0 Acute (SF-36) (Physical Component Summary (PCS))	3.41 scores on a scale Standard Deviation 6.65	3.83 scores on a scale Standard Deviation 7.22

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change from baseline (week 0) to week 56 in short form 36 v2.0 acute domain mental component summary (MCS). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 mental component summary is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Short Form-36 v2.0 Acute (SF-36) (Mental Component Summary (MCS)	-1.22 scores on a scale Standard Deviation 8.74	-2.20 scores on a scale Standard Deviation 8.11

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT) domain pain and discomfort. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Pain/Discomfort Domain Score	10.1 scores on a scale Standard Deviation 21.2	8.6 scores on a scale Standard Deviation 23.1

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT) psychosocial domain. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Psychosocial Domain Score	13.5 score Standard Deviation 20.3	12.4 score Standard Deviation 21.8

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change from baseline (week 0) to week 56 in IWQoL-Lite for CT total score. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Total Score	13.2 scores on a scale Standard Deviation 18.5	12.8 scores on a scale Standard Deviation 20.7

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Observed mean change from baseline (week 0) to week 56 in WRSS measure, total score. The WRSS measures the presence and bothersome associated with weight-related symptoms.

The WRSS questionnaire was not validated until after database lock. Therefore the total score couldn't be calculated and the supportive secondary endpoint "Weight related sign and symptom (WRSS) measure, total score" couldn't be analysed.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Weight Related Sign and Symptom (WRSS) Measure, Total Score	NA Score on a scale Standard Deviation NA The WRSS questionnaire was not validated until after database lock. Therefore the total score couldn't be calculated and the supportive secondary endpoint "Weight related sign and symptom (WRSS) measure, total score" couldn't be analysed.	NA Score on a scale Standard Deviation NA The WRSS questionnaire was not validated until after database lock. Therefore the total score couldn't be calculated and the supportive secondary endpoint "Weight related sign and symptom (WRSS) measure, total score" couldn't be analysed.

SECONDARY outcome

Timeframe: Week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Percentage of subjects who achieved ≥ 4.3 T-score points increase from baseline in SF-36 physical functioning score at week 56 is presented. Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.3 T-score Points Increase From Baseline in SF-36 Physical Functioning Score	38.7 percentage of participants	37.9 percentage of participants

SECONDARY outcome

Timeframe: Week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Percentage of subjects who achieved ≥ 3.8 T-score points increase from baseline in SF-36 physical component score at week 56 is presented. Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 3.8 T-score Points Increase From Baseline in SF-36 Physical Component Score	43.7 Percentage of participants	41.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Percentage of subjects who achieved ≥ 4.6 T-score points increase from baseline in SF-36 mental component score at week 56 is presented. Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.6 T-score Points Increase From Baseline in SF-36 Mental Component Score	20.4 Percentage of participants	9.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Responder definition value for IWQoL-Lite for CT physical function domain (5-items) score' was defined as '≥ 20 responder definition value for IWQoL-Lite for CT physical function domain (5-items) score. Percentage of subjects considered IWQoL-Lite for CT physical function domain score responders (increase of ≥20 points) at week 56 is presented. Results based on FAS in-trial data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Responder Definition Value for IWQoL-Lite for CT Physical Function Domain (5-items) Score	37.3 Percentage of participants	34.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Adherence to trial product is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to trial product is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Trial Product	49.5 weeks Standard Deviation 14.0	46.8 weeks Standard Deviation 16.1

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Adherence to caloric diet is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet	38.4 weeks Standard Deviation 16.0	36.1 weeks Standard Deviation 17.3

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Adherence to physical activity is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to physical activity is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Physical Activity	29.0 weeks Standard Deviation 17.1	30.0 weeks Standard Deviation 17.2

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Adherence to caloric diet and physical activity is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet and physical activity is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet and Physical Activity	24.0 weeks Standard Deviation 16.0	24.5 weeks Standard Deviation 15.7

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.

Adherence to caloric diet, physical activity and trial product is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet, physical activity and trial product is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet, Physical Activity and Trial Product	22.9 weeks Standard Deviation 16.1	24.0 weeks Standard Deviation 15.9

SECONDARY outcome

Timeframe: Week 0 to week 56+30 days

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

Number of adverse events from randomisation to until the end of the post-treatment follow-up period (30 days). Results based on SAS on-drug data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
AEs From Randomisation Until and Including the Follow-up Period	867 events	601 events

SECONDARY outcome

Timeframe: Week 1, week 56

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

Observed change from baseline to week 56 in physical examination are categorised under parameters namely abdomen, gastrointestinal system, cardiovascular system, central and peripheral nervous system, general appearence, head, ears, eyes, nose, throat and neck, lymph node palpation, musculoskeletal system, respiratory system, skin and thyroid gland. The percentage of subjects assessed as normal, abnormal not clinically significant and abnormal clinically significant at baseline and week 56 is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Physical Examination General Appearance (week 56) Abnormal CS	0 participants	0 participants
Change in Physical Examination Head, ENTand Neck (week -1) Normal	129 participants	128 participants
Change in Physical Examination Head, ENTand Neck (week -1) Abnormal NCS	13 participants	12 participants
Change in Physical Examination Abdomen (week -1) Normal	108 participants	121 participants
Change in Physical Examination Abdomen (week -1) Abnormal, NCS	34 participants	19 participants
Change in Physical Examination Abdomen (week -1) Abnormal CS	0 participants	0 participants
Change in Physical Examination Abdomen (week 56) Normal	114 participants	108 participants
Change in Physical Examination Abdomen (week 56) Abnormal, NCS	25 participants	12 participants
Change in Physical Examination Abdomen (week 56) Abnormal, CS	0 participants	2 participants
Change in Physical Examination Gastrointestinal System (week -1) Normal	130 participants	129 participants
Change in Physical Examination Gastrointestinal System (week -1) Abnormal NCS	12 participants	11 participants
Change in Physical Examination Gastrointestinal System (week -1) Abnormal CS	0 participants	0 participants
Change in Physical Examination Gastrointestinal System (week 56) Normal	132 participants	116 participants
Change in Physical Examination Gastrointestinal System (week 56) Abnormal NCS	7 participants	6 participants
Change in Physical Examination Gastrointestinal System (week 56) Abnormal CS	0 participants	0 participants
Change in Physical Examination Cardiovascular System (week-1) Normal	136 participants	127 participants
Change in Physical Examination Cardiovascular System (week-1) Abnormal NCS	6 participants	13 participants
Change in Physical Examination Cardiovascular System (week-1) Abnormal CS	0 participants	0 participants
Change in Physical Examination Cardiovascular System (week 56) Normal	138 participants	116 participants
Change in Physical Examination Cardiovascular System (week 56) Abnormal NCS	1 participants	5 participants
Change in Physical Examination Cardiovascular System (week 56) Abnormal CS	0 participants	1 participants
Change in Physical Examination Nervous System (week -1) Normal	135 participants	127 participants
Change in Physical Examination Nervous System (week -1) Abnormal NCS	5 participants	6 participants
Change in Physical Examination Nervous System (week -1) Abnormal CS	2 participants	7 participants
Change in Physical Examination Nervous System (week 56) Normal	132 participants	112 participants
Change in Physical Examination Nervous System (week 56) Abnormal NCS	6 participants	9 participants
Change in Physical Examination Nervous System (week 56) Abnormal CS	1 participants	1 participants
Change in Physical Examination General Appearance (week -1) Normal	118 participants	123 participants
Change in Physical Examination General Appearance (week -1) Abnormal NCS	24 participants	17 participants
Change in Physical Examination General Appearance (week -1) Abnormal CS	0 participants	0 participants
Change in Physical Examination General Appearance (week 56) Normal	122 participants	112 participants
Change in Physical Examination General Appearance (week 56) Abnormal NCS	17 participants	10 participants
Change in Physical Examination Head, ENTand Neck (week -1) Abnormal CS	0 participants	0 participants
Change in Physical Examination Head, ENTand Neck (week 56) Normal	126 participants	115 participants
Change in Physical Examination Head, ENTand Neck (week 56) Abnormal NCS	13 participants	7 participants
Change in Physical Examination Head, ENTand Neck (week 56) Abnormal CS	0 participants	0 participants
Change in Physical Examination Lymph Node Palpation (week -1) Normal	142 participants	140 participants
Change in Physical Examination Lymph Node Palpation (week -1) Abnormal NCS	0 participants	0 participants
Change in Physical Examination Lymph Node Palpation (week -1) Abnormal CS	0 participants	0 participants
Change in Physical Examination Lymph Node Palpation (week 56) Normal	139 participants	121 participants
Change in Physical Examination Lymph Node Palpation (week 56) Abnormal NCS	0 participants	0 participants
Change in Physical Examination Lymph Node Palpation (week 56) Abnormal CS	0 participants	1 participants
Change in Physical Examination Musculoskeletal System (week -1) Normal	131 participants	128 participants
Change in Physical Examination Musculoskeletal System (week -1) Abnormal NCS	11 participants	12 participants
Change in Physical Examination Musculoskeletal System (week -1) Abnormal CS	0 participants	0 participants
Change in Physical Examination Musculoskeletal System (week 56) Normal	130 participants	112 participants
Change in Physical Examination Musculoskeletal System (week 56) Abnormal NCS	9 participants	9 participants
Change in Physical Examination Musculoskeletal System (week 56) Abnormal CS	0 participants	1 participants
Change in Physical Examination Respiratory System (week -1) Normal	140 participants	138 participants
Change in Physical Examination Respiratory System (week -1) Abnormal NCS	2 participants	2 participants
Change in Physical Examination Respiratory System (week -1) Abnormal CS	0 participants	0 participants
Change in Physical Examination Respiratory System (week 56) Normal	138 participants	120 participants
Change in Physical Examination Respiratory System (week 56) Abnormal NCS	1 participants	2 participants
Change in Physical Examination Respiratory System (week 56) Abnormal CS	0 participants	0 participants
Change in Physical Examination Skin (week -1) Normal	116 participants	114 participants
Change in Physical Examination Skin (week -1) Abnormal NCS	26 participants	24 participants
Change in Physical Examination Skin (week -1) Abnormal CS	1 participants	0 participants
Change in Physical Examination Skin (week 56) Normal	117 participants	98 participants
Change in Physical Examination Skin (week 56) Abnormal NCS	21 participants	24 participants
Change in Physical Examination Skin (week 56) Abnormal CS	1 participants	0 participants
Change in Physical Examination Thyroid Gland (week -1) Normal	138 participants	138 participants
Change in Physical Examination Thyroid Gland (week -1) Abnormal NCS	4 participants	2 participants
Change in Physical Examination Thyroid Gland (week -1) Abnormal CS	0 participants	0 participants
Change in Physical Examination Thyroid Gland (week 56) Normal	136 participants	120 participants
Change in Physical Examination Thyroid Gland (week 56) Abnormal NCS	3 participants	2 participants
Change in Physical Examination Thyroid Gland (week 56) Abnormal CS	0 participants	0 participants

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

Observed mean change in pulse rate measured at resting position is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Resting Pulse	2 beats/min Standard Deviation 10	1 beats/min Standard Deviation 10

SECONDARY outcome

Timeframe: Week -1, week 56

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

The ECGs were interpreted by the investigator at baseline (week -1) and week 56 and categorised as normal, abnormal NCS or abnormal CS. Number of subjects in each ECG category at baseline and week 56 are presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in ECG Normal (week -1)	100 participants	91 participants
Change in ECG Abnormal NCS (week -1)	41 participants	49 participants
Change in ECG Abnormal CS (week -1)	1 participants	0 participants
Change in ECG Normal (week 56)	102 participants	81 participants
Change in ECG Abnormal NCS (week 56)	36 participants	42 participants
Change in ECG Abnormal CS (week 56)	0 participants	1 participants

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

Observed mean change from baseline in haematological parameter blood haemoglobin.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Laboratory Measurements: Haematology (Haemoglobin Blood)	-0.2 mmol/L Standard Deviation 0.5	-0.1 mmol/L Standard Deviation 0.6

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

Observed mean change from baseline in haematological parameter blood haematocrit. Haematocrit is presented as the percentage of red blood cells in total blood. Results based on SAS on-drug data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Laboratory Measurements: Haematology (Haematocrit Blood)	-1.5 percentage of red blood cells Standard Deviation 2.3	-0.9 percentage of red blood cells Standard Deviation 2.6

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

Observed mean change from baseline in haematological parameter - erythrocytes.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Laboratory Measurements: Haematology (Erythrocytes)	-0.11 10^12 cells/L Standard Deviation 0.25	-0.08 10^12 cells/L Standard Deviation 0.25

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

Observed mean change from baseline in haematological parameters - thrombocytss and leukocytes.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Laboratory Measurements: Haematology (Thrombocytes and Leukocytes) Thrombocytes	4 10^9 cells/L Standard Deviation 30	0 10^9 cells/L Standard Deviation 36
Change in Laboratory Measurements: Haematology (Thrombocytes and Leukocytes) Leukocytes	-0.14 10^9 cells/L Standard Deviation 1.53	-0.11 10^9 cells/L Standard Deviation 1.20

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

Observed mean change from baseline in biochemical parameter - albumin. Results based on SAS on-drug data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Laboratory Measurements: Biochemistry (Albumin)	-0.1 g/L Standard Deviation 0.2	-0.1 g/L Standard Deviation 0.2

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

Observed mean change from baseline in biochemical parameters - alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase and lipase. Results based on SAS on-drug data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase) Alkaline Phosphatase	-2 U/L Standard Deviation 12	-1 U/L Standard Deviation 13
Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase) Alanine Aminotransferase	-5 U/L Standard Deviation 14	-4 U/L Standard Deviation 16
Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase) Amylase	4 U/L Standard Deviation 10	1 U/L Standard Deviation 13
Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase) Aspartate aminotransferase	-3 U/L Standard Deviation 10	-2 U/L Standard Deviation 12
Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase) Lipase	7 U/L Standard Deviation 18	2 U/L Standard Deviation 22

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

Observed mean change from baseline in biochemical parameters - bilirubin and creatinine. Results based on SAS on-drug data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Laboratory Measurements: Biochemistry (Bilirubin and Creatinine) Bilirubin	1.1 umol/L Standard Deviation 3.2	1.0 umol/L Standard Deviation 3.2
Change in Laboratory Measurements: Biochemistry (Bilirubin and Creatinine) Creatinine	-1.8 umol/L Standard Deviation 7.9	-1.4 umol/L Standard Deviation 6.1

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

Observed mean change from baseline in biochemical parameters - total calcium, pottassium, sodium and urea. Results based on SAS on-drug data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea) Urea	0.0 mmol/L Standard Deviation 1.2	0.2 mmol/L Standard Deviation 1.2
Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea) Total Calcium	0.01 mmol/L Standard Deviation 0.10	0.01 mmol/L Standard Deviation 0.09
Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea) Potassium	-0.0 mmol/L Standard Deviation 0.5	-0.0 mmol/L Standard Deviation 0.4
Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea) Sodium	-0.0 mmol/L Standard Deviation 2	-0 mmol/L Standard Deviation 2

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

Observed mean change from baseline in biochemical parameters - high sensitive c-reactive protein and uric acid. Results based on SAS on-drug data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Laboratory Measurements: Biochemistry (C-reactive Protein and Uric Acid) High sensitive c-reactive protein	-2.51 mg/dL Standard Deviation 4.67	-0.85 mg/dL Standard Deviation 8.96
Change in Laboratory Measurements: Biochemistry (C-reactive Protein and Uric Acid) Uric acid	-0.6 mg/dL Standard Deviation 0.9	-0.3 mg/dL Standard Deviation 0.9

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

Observed mean change from baseline in biochemical parameters - estimated glomerular filtration rate. Serum GFR is estimated using MDRD formula . Results based on SAS on-drug data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Laboratory Measurements: Biochemistry (Glomerular Filtration Rate, Serum)	2 mL/min/1.73m^2 Standard Deviation 11	2 mL/min/1.73m^2 Standard Deviation 9

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

Observed mean change from baseline in biochemical parameter - calcitonin. Results based on SAS on-drug data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Laboratory Measurements: Biochemistry (Calcitonin)	0.2 ng/L Standard Deviation 0.8	0.1 ng/L Standard Deviation 0.8

SECONDARY outcome

Timeframe: Week 0, week 56

Population: Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.

Observed mean change from baseline in biochemical parameters - thyroid stimulating hormone. Results based on SAS on-drug data is presented.

Outcome measures

Measure	Liraglutide 3.0 mg n=142 Participants Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 Participants Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Change in Laboratory Measurements: Biochemistry (Thyroid Stimulating Hormone)	-0.2313 mIU/L Standard Deviation 1.0366	0.2685 mIU/L Standard Deviation 3.6814

Adverse Events

Lira 3.0 mg

Serious events: 6 serious events

Other events: 124 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 101 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lira 3.0 mg n=142 participants at risk Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 participants at risk Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/142 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.71% 1/140 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Hepatobiliary disorders Cholecystitis acute	0.70% 1/142 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/140 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Colitis	0.70% 1/142 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/140 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Nervous system disorders Headache	0.70% 1/142 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/140 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Nervous system disorders Hydrocephalus	0.00% 0/142 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.71% 1/140 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.70% 1/142 • Number of events 2 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/140 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Reproductive system and breast disorders Ovarian cyst	0.70% 1/142 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/140 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.70% 1/142 • Number of events 1 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	0.00% 0/140 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.

Other adverse events

Measure	Lira 3.0 mg n=142 participants at risk Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.	Placebo n=140 participants at risk Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Gastrointestinal disorders Abdominal discomfort	5.6% 8/142 • Number of events 9 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	2.9% 4/140 • Number of events 4 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Musculoskeletal and connective tissue disorders Arthralgia	6.3% 9/142 • Number of events 10 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	11.4% 16/140 • Number of events 20 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Musculoskeletal and connective tissue disorders Back pain	5.6% 8/142 • Number of events 10 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	9.3% 13/140 • Number of events 14 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Constipation	30.3% 43/142 • Number of events 57 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	18.6% 26/140 • Number of events 34 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Respiratory, thoracic and mediastinal disorders Cough	4.9% 7/142 • Number of events 7 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	6.4% 9/140 • Number of events 11 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Diarrhoea	21.8% 31/142 • Number of events 47 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	16.4% 23/140 • Number of events 26 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Nervous system disorders Dizziness	6.3% 9/142 • Number of events 10 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	4.3% 6/140 • Number of events 6 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Dyspepsia	5.6% 8/142 • Number of events 13 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	2.1% 3/140 • Number of events 3 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
General disorders Fatigue	9.2% 13/142 • Number of events 15 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	3.6% 5/140 • Number of events 5 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Infections and infestations Gastroenteritis viral	2.1% 3/142 • Number of events 5 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	6.4% 9/140 • Number of events 9 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Nervous system disorders Headache	14.1% 20/142 • Number of events 23 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	9.3% 13/140 • Number of events 29 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Infections and infestations Influenza	3.5% 5/142 • Number of events 5 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	9.3% 13/140 • Number of events 13 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Injury, poisoning and procedural complications Ligament sprain	4.2% 6/142 • Number of events 6 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	6.4% 9/140 • Number of events 9 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Nervous system disorders Migraine	2.1% 3/142 • Number of events 3 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	6.4% 9/140 • Number of events 12 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Injury, poisoning and procedural complications Muscle strain	2.1% 3/142 • Number of events 3 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	5.0% 7/140 • Number of events 8 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Infections and infestations Nasopharyngitis	9.2% 13/142 • Number of events 17 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	6.4% 9/140 • Number of events 13 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Nausea	47.9% 68/142 • Number of events 102 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	17.9% 25/140 • Number of events 33 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.4% 2/142 • Number of events 2 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	5.0% 7/140 • Number of events 8 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Infections and infestations Sinusitis	6.3% 9/142 • Number of events 10 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	12.9% 18/140 • Number of events 20 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Infections and infestations Upper respiratory tract infection	22.5% 32/142 • Number of events 38 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	10.7% 15/140 • Number of events 17 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Infections and infestations Urinary tract infection	5.6% 8/142 • Number of events 15 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	2.1% 3/140 • Number of events 3 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.
Gastrointestinal disorders Vomiting	23.2% 33/142 • Number of events 47 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.	5.0% 7/140 • Number of events 7 • From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days. Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product. AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

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