Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE - Maintenance

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT00781937

Collaborator

(none)

422

Enrollment

Locations

Arms

Actual Duration (Months)

11.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in North America. The aim of this clinical trial is to evaluate the potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as well as in overweight subjects who have medical problems such as hypertension (high blood pressure) or dyslipidaemia (an abnormal amount of lipids in the blood).

Trial has following trial periods: A 12-week run-in period (from week -12 to week 0) followed by a 56-week main trial period (weeks 0-56) and a 12-week follow-up period (weeks 56-68).

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

Study Design

Study Type:

Interventional

Actual Enrollment :

422 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Effect of Liraglutide on Long-term Weight Maintenance and Additional Weight Loss Induced by a 4 to 12 Week Low Calorie Diet in Obese Subjects; A 56 Week Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial With a 12 Week Follow-up Period

Actual Study Start Date :

Oct 30, 2008

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lira 3.0 mg A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	Drug: liraglutide Liraglutide 3.0 mg per day administered in a 6.0 mg/mL, 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily
Placebo Comparator: Placebo A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period	Drug: placebo Liraglutide placebo 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily

Arm

Intervention/Treatment

Experimental: Lira 3.0 mg

A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached

Drug: liraglutide

Liraglutide 3.0 mg per day administered in a 6.0 mg/mL, 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily

Placebo Comparator: Placebo

A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period

Drug: placebo

Liraglutide placebo 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily

Outcome Measures

Primary Outcome Measures

Mean Percentage Change in Fasting Body Weight From Baseline [Week 0, week 56]
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0 [Week 0, week 56]
Subjects who had a weight regain less than or equal to 0.5% of weight from Week 0 were regarded as maintenance of run-in fasting weight loss. Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0 [Week 0, week 56]
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Secondary Outcome Measures

Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0 [Week 0, week 56]
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0 [Week 0, week 56]
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0 [Week 0, week 56]
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0 [Week 0, week 56]
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0 [Week 0, week 56]
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Change From Baseline in Fasting Weight [Week 0, week 56]
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period [Week 0, week 68]
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Change From Baseline in Blood Pressure [Week 0, week 56]
Change From Baseline in Pulse [Week 0, week 56]
Change From Baseline in Fasting Lipid Profile: Triglycerides [Week 0, week 56]
Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol [Week 0, week 56]
Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Change From Baseline in Fasting Lipid Profile: Total Cholesterol [Week 0, week 56]
Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP) [Week 0, week 56]
Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56 [Week 56]
Metabolic syndrome status required at least 3 of 5 criteria met: Waist circumference (men ≥102cm, women ≥88cm); Triglycerides >1.7mmol/L; High density lipoprotein cholesterol (men <0.9mmol/L, women <1.1mmol/L) or on drug therapy; Blood pressure ≥130mmHg systolic or ≥85mmHg diastolic or on drug therapy; Fasting glucose ≥5.5mmol/L or on drug therapy.
Change From Baseline in Waist Circumference [Week 0, week 56]
Change From Baseline in Body Mass Index (BMI) [Week 0, week 56]
Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function) [Week 0, week 56]
Change in beta-cell function percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%]. Beta-cell function was derived from fasting plasma glucose readings in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median beta-cell function indexed at 100%.
Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance) [Week 0, week 56]
Change in insulin resistance values from Week 0 (X) to Week 56 (Y) was calculated [X - Y]. Insulin resistance was derived from fasting serum insulin levels in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median insulin resistance indexed at 1.00.
Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG) [Week 0, week 56]
Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin [Week 0, week 56]
Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin) [Week 0, week 56]
Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%].
Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications) [Week 0 and week 56]
Number of subjects using concomitant medications at Week 0 and Week 56, respectively
Binge Eating Scale Scores by Week and Severity [Week 0, week 50 and week 57]
Binge Eating Scale (BES) scores are based on responses to the Binge Eating Scale Questionnaire, a 16-item self-reporting diagnostic tool scaled 0-46 (Non-binging: 0-17; Moderate: 17-26; Severe: 27-46)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Body Mass Index (BMI) of either 30 kg/m^{2 or more or BMI of less than 30 kg/m}2 to 27 kg/m^2 with presence of co-morbidities
Stable body weight during the previous 3 months (less than 5 kg self-reported weight change)
Previously undergone dietary weight loss and was not able to maintain reduced weight

Exclusion Criteria:

Diagnosis of type 1 or type 2 diabetes
Previous treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (including liraglutide or exenatide), within the last 3 months
Visit 1 thryoid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L
History of chronic pancreatitis or idiopathic acute pancreatitis
Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome)
Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial
Current participation in an organized diet reduction program (or within the last 3 months)
Currently using or have used within three months before this trial: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phenteremine, or metformin
Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry)
History of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders or diagnosis of an eating disorder
Subjects with a lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Goodyear	Arizona	United States	85395
2	Novo Nordisk Investigational Site	Peoria	Arizona	United States	85381
3	Novo Nordisk Investigational Site	Huntington Beach	California	United States	92648
4	Novo Nordisk Investigational Site	Montclair	California	United States	91763
5	Novo Nordisk Investigational Site	Colorado Springs	Colorado	United States	80909
6	Novo Nordisk Investigational Site	Hialeah	Florida	United States	33013-3835
7	Novo Nordisk Investigational Site	Pembroke Pines	Florida	United States	33024
8	Novo Nordisk Investigational Site	Atlanta	Georgia	United States	30106
9	Novo Nordisk Investigational Site	Meridian	Idaho	United States	83642
10	Novo Nordisk Investigational Site	Louisville	Kentucky	United States	40213
11	Novo Nordisk Investigational Site	Madisonville	Kentucky	United States	42431
12	Novo Nordisk Investigational Site	Southfield	Michigan	United States	48034
13	Novo Nordisk Investigational Site	Saint Louis	Missouri	United States	63110
14	Novo Nordisk Investigational Site	Butte	Montana	United States	59701
15	Novo Nordisk Investigational Site	Endwell	New York	United States	13760
16	Novo Nordisk Investigational Site	New York	New York	United States	10065
17	Novo Nordisk Investigational Site	Wilmington	North Carolina	United States	28401
18	Novo Nordisk Investigational Site	Winston-Salem	North Carolina	United States	27103
19	Novo Nordisk Investigational Site	Cincinnati	Ohio	United States	45236
20	Novo Nordisk Investigational Site	Cincinnati	Ohio	United States	45245
21	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19104
22	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19107
23	Novo Nordisk Investigational Site	Charleston	South Carolina	United States	29406
24	Novo Nordisk Investigational Site	Nashville	Tennessee	United States	37212
25	Novo Nordisk Investigational Site	Dallas	Texas	United States	75246
26	Novo Nordisk Investigational Site	Round Rock	Texas	United States	78681
27	Novo Nordisk Investigational Site	Norfolk	Virginia	United States	23502
28	Novo Nordisk Investigational Site	Winnipeg	Manitoba	Canada	R3E 3P4
29	Novo Nordisk Investigational Site	Burlington	Ontario	Canada	L7M 4Y1
30	Novo Nordisk Investigational Site	Hamilton	Ontario	Canada	L8L 5G8
31	Novo Nordisk Investigational Site	Sarnia	Ontario	Canada	N7T 4X3
32	Novo Nordisk Investigational Site	Laval	Quebec	Canada	H7T 2P5
33	Novo Nordisk Investigational Site	Mirabel	Quebec	Canada	J7J 2K8
34	Novo Nordisk Investigational Site	Sherbrooke	Quebec	Canada	J1H 4J6
35	Novo Nordisk Investigational Site	Trois Rivières	Quebec	Canada	G8T 7A1
36	Novo Nordisk Investigational Site	London		Canada	N5Y 5K7
37	Novo Nordisk Investigational Site	Montreal		Canada	H2W 1R7

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Clinical Trials at Novo Nordisk

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT00781937

Other Study ID Numbers:

NN8022-1923

First Posted:

Oct 29, 2008

Last Update Posted:

Nov 1, 2017

Last Verified:

Sep 1, 2017

Additional relevant MeSH terms:

Nutrition Disorders

Weight Loss

Liraglutide

Study Results

Participant Flow

Recruitment Details	The trial was conducted at 26 sites in the United States and 10 sites in Canada.
Pre-assignment Detail	Subjects who lost at least 5% of screening body weight after 4 weeks and up to 12 weeks during the run-in were randomised in a 1:1 manner to receive either liraglutide 3.0 mg, or placebo for 56 weeks.

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Period Title: Main Trial Period Through Week 56
STARTED	212	210
COMPLETED	159	146
NOT COMPLETED	53	64
Period Title: Main Trial Period Through Week 56
STARTED	159	146
COMPLETED	153	141
NOT COMPLETED	6	5

Baseline Characteristics

Arm/Group Title	Lira 3.0 mg	Placebo	Total
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period	Total of all reporting groups
Overall Participants	212	210	422
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.9 (11.9)	46.5 (11.0)	46.2 (11.5)
Sex: Female, Male (Count of Participants)
Female	178 84%	165 78.6%	343 81.3%
Male	34 16%	45 21.4%	79 18.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	17 8%	11 5.2%	28 6.6%
Not Hispanic or Latino	195 92%	199 94.8%	394 93.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 0.5%	0 0%	1 0.2%
Native Hawaiian or Other Pacific Islander	2 0.9%	0 0%	2 0.5%
Black or African American	32 15.1%	24 11.4%	56 13.3%
White	170 80.2%	185 88.1%	355 84.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	7 3.3%	1 0.5%	8 1.9%
Co-morbidity status (participants) [Number]
Present	94 44.3%	96 45.7%	190 45%
Absent	118 55.7%	114 54.3%	232 55%
Co-morbidity status and Body Mass Index (BMI) (participants) [Number]
Present and BMI (27-30) kg/m^2	3 1.4%	6 2.9%	9 2.1%
Present and BMI >=30 kg/m^2	91 42.9%	90 42.9%	181 42.9%
Absent and BMI >=30 kg/m^2	118 55.7%	114 54.3%	232 55%
Smoking (participants) [Number]
Yes	20 9.4%	22 10.5%	42 10%
No	192 90.6%	188 89.5%	380 90%
Height (meters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [meters]	1.67 (0.09)	1.67 (0.09)	1.67 (0.09)
Weight at screening (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	106.7 (21.8)	105.0 (22.4)	105.9 (22.1)
Weight at randomisation (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	100.4 (20.8)	98.7 (21.2)	99.6 (21.0)
Body Mass Index (BMI) at screening (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	38.2 (6.2)	37.5 (6.2)	37.9 (6.2)
Body Mass Index (BMI) group (kg/m^2) at screening (participants) [Number]
27-30	3 1.4%	6 2.9%	9 2.1%
30-35	69 32.5%	80 38.1%	149 35.3%
35-40	69 32.5%	58 27.6%	127 30.1%
Greater than or equal to 40	71 33.5%	66 31.4%	137 32.5%
Body Mass Index (BMI) at randomisation (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	36.0 (5.9)	35.2 (5.9)	35.6 (5.9)

Outcome Measures

1. Primary Outcome

Title	Mean Percentage Change in Fasting Body Weight From Baseline
Description	Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	194	188
Least Squares Mean (Standard Error) [percentage]	-6.11 (0.66)	-0.05 (0.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments	The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	-6.06
	Confidence Interval	() 95% -7.50 to -4.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0
Description	Subjects who had a weight regain less than or equal to 0.5% of weight from Week 0 were regarded as maintenance of run-in fasting weight loss. Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	194	188
Number [percentage of subjects]	80.8	47.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments	The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Two sided, conducted at a 5% significance level
	Method	Regression, Logistic
	Comments	The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.82
	Confidence Interval	() 95% 3.01 to 7.71
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0
Description	Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	194	188
Number [percentage of subjects]	50.5	21.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments	The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Two sided, conducted at a 5% significance level
	Method	Regression, Logistic
	Comments	The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.86
	Confidence Interval	() 95% 2.44 to 6.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0
Description	Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	194	188
Number [percentage of subjects]	26.1	6.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Two sided, conducted at a 5% significance level
	Method	Regression, Logistic
	Comments	The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	5.30
	Confidence Interval	() 95% 2.79 to 10.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0
Description	Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	207	206
Number [percentage of subjects]	1.9	17.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Two sided, conducted at a 5% significance level
	Method	Regression, Logistic
	Comments	The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.09
	Confidence Interval	() 95% 0.03 to 0.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0
Description	Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	207	206
Number [percentage of subjects]	0	2.9

7. Secondary Outcome

Title	Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0
Description	Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	207	206
Number [percentage of subjects]	93.2	70.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Two sided, conducted at a 5% significance level
	Method	Regression, Logistic
	Comments	The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	5.86
	Confidence Interval	() 95% 3.12 to 10.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0
Description	Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	207	206
Number [percentage of subjects]	87.4	54.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Two sided, conducted at a 5% significance level
	Method	Regression, Logistic
	Comments	The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	6.02
	Confidence Interval	() 95% 3.65 to 9.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Change From Baseline in Fasting Weight
Description	Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	194	188
Least Squares Mean (Standard Error) [kg]	-5.7 (0.66)	0.16 (0.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	-5.86
	Confidence Interval	() 95% -7.30 to -4.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period
Description	Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Time Frame	Week 0, week 68

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	159	144
Least Squares Mean (Standard Error) [kg]	-3.83 (0.82)	0.41 (0.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	-4.23
	Confidence Interval	() 95% -6.04 to -2.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Change From Baseline in Blood Pressure
Description
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	207	206
Change in Systolic Blood Pressure	1.31 (0.90)	4.03 (0.87)
Change in Diastolic Blood Pressure	1.81 (0.64)	2.15 (0.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments	Analysis is of treatment contrast, change in systolic blood pressure.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0068
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	-2.72
	Confidence Interval	() 95% -4.69 to -0.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments	Analysis is of treatment contrast, change in diastolic blood pressure.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.6386
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	-0.34
	Confidence Interval	() 95% -1.74 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Change From Baseline in Pulse
Description
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	207	206
Least Squares Mean (Standard Error) [beats/minute]	4.12 (0.68)	3.15 (0.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1968
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	0.97
	Confidence Interval	() 95% -0.51 to 2.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Change From Baseline in Fasting Lipid Profile: Triglycerides
Description	Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	194	187
Least Squares Mean (Standard Error) [mmol/L]	0.02 (0.04)	0.12 (0.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0310
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	-0.11
	Confidence Interval	() 95% -0.20 to -0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol
Description	Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	194	187
Least Squares Mean (Standard Error) [mmol/L]	0.24 (0.05)	0.33 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1098
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	-0.09
	Confidence Interval	() 95% -0.20 to 0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Change From Baseline in Fasting Lipid Profile: Total Cholesterol
Description	Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	194	187
Least Squares Mean (Standard Error) [mmol/L]	0.22 (0.06)	0.33 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1149
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	-0.11
	Confidence Interval	() 95% -0.24 to 0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)
Description
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	185	174
Least Squares Mean (Standard Error) [nmol/L]	-11.31 (4.62)	1.70 (4.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0141
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	-13.01
	Confidence Interval	() 95% -23.40 to -2.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56
Description	Metabolic syndrome status required at least 3 of 5 criteria met: Waist circumference (men ≥102cm, women ≥88cm); Triglycerides >1.7mmol/L; High density lipoprotein cholesterol (men <0.9mmol/L, women <1.1mmol/L) or on drug therapy; Blood pressure ≥130mmHg systolic or ≥85mmHg diastolic or on drug therapy; Fasting glucose ≥5.5mmol/L or on drug therapy.
Time Frame	Week 56

Outcome Measure Data

Analysis Population Description
Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	194	188
Number [percentage of subjects]	31.4	36.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1199
	Comments	Two sided, conducted at a 5% significance level
	Method	Regression, Logistic
	Comments	The analysis included treatment, gender, and stratification factor(s) as fixed effects and metabolic status and weight at baseline as covariates.

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.64
	Confidence Interval	() 95% 0.36 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Change From Baseline in Waist Circumference
Description
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	207	206
Least Squares Mean (Standard Error) [cm]	-4.36 (0.62)	-0.86 (0.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	-3.50
	Confidence Interval	() 95% -4.84 to -2.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Secondary Outcome

Title	Change From Baseline in Body Mass Index (BMI)
Description
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	207	206
Least Squares Mean (Standard Error) [kg/m^2]	-1.90 (0.22)	0.15 (0.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	-2.05
	Confidence Interval	() 95% -2.53 to -1.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

20. Secondary Outcome

Title	Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)
Description	Change in beta-cell function percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%]. Beta-cell function was derived from fasting plasma glucose readings in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median beta-cell function indexed at 100%.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	190	181
Least Squares Mean (Standard Error) [percent change]	8.51 (2.33)	6.16 (2.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3689
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	2.35
	Confidence Interval	() 95% -2.79 to 7.49
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Secondary Outcome

Title	Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)
Description	Change in insulin resistance values from Week 0 (X) to Week 56 (Y) was calculated [X - Y]. Insulin resistance was derived from fasting serum insulin levels in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median insulin resistance indexed at 1.00.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	190	181
Least Squares Mean (Standard Error) [proportion]	-0.01 (0.03)	0.08 (0.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0053
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	-0.10
	Confidence Interval	() 95% -0.16 to -0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

22. Secondary Outcome

Title	Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)
Description	Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	194	188
Least Squares Mean (Standard Error) [mmol/L]	-0.52 (0.05)	-0.14 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	-0.38
	Confidence Interval	() 95% -0.50 to -0.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

23. Secondary Outcome

Title	Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin
Description	Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	194	188
Least Squares Mean (Standard Error) [pmol/L]	0.50 (0.67)	2.35 (0.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0147
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	-1.85
	Confidence Interval	() 95% -3.34 to -0.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

24. Secondary Outcome

Title	Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)
Description	Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%].
Time Frame	Week 0, week 56

Outcome Measure Data

Analysis Population Description
Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	194	188
Least Squares Mean (Standard Error) [percentage point]	-0.14 (0.03)	0.13 (0.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lira 3.0 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Two sided, conducted at a 5% significance level
	Method	ANCOVA
	Comments	The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.

Method of Estimation	Estimation Parameter	Treatment Contrast
	Estimated Value	-0.27
	Confidence Interval	() 95% -0.33 to -0.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

25. Secondary Outcome

Title	Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)
Description	Number of subjects using concomitant medications at Week 0 and Week 56, respectively
Time Frame	Week 0 and week 56

Outcome Measure Data

Analysis Population Description
Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	207	206
Antihypertensive drug - Week 0	65	66
Antihypertensive drug - Week 56	63	63
Antipsychotic drug - Week 0	18	25
Antipsychotic drug - Week 56	20	29
Lipid lowering drug - Week 0	45	45
Lipid lowering drug - Week 56	52	50

26. Secondary Outcome

Title	Binge Eating Scale Scores by Week and Severity
Description	Binge Eating Scale (BES) scores are based on responses to the Binge Eating Scale Questionnaire, a 16-item self-reporting diagnostic tool scaled 0-46 (Non-binging: 0-17; Moderate: 17-26; Severe: 27-46)
Time Frame	Week 0, week 50 and week 57

Outcome Measure Data

Analysis Population Description
Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)

Arm/Group Title	Lira 3.0 mg	Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Measure Participants	207	206
Week 0, baseline	7.8 (5.6)	7.8 (6.2)
Week 50	6.6 (5.6)	8.6 (7.0)
Week 57	6.6 (5.8)	6.9 (6.2)

Adverse Events

	Lira 3.0 mg		Placebo
Time Frame	Treatment emergent adverse events were defined as occurring before randomisation and increasing in severity during treatment, or had onset on or after first day of randomised treatment and no later than 7 days after last day of randomised treatment.
Adverse Event Reporting Description	Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.

Arm/Group Title	Lira 3.0 mg		Placebo
Arm/Group Description	A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached		A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lira 3.0 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/212 (4.2%)		5/210 (2.4%)
Cardiac disorders
Cardiac Failure	0/212 (0%)	0	1/210 (0.5%)	1
Gastrointestinal disorders
Colitis Ischaemic	1/212 (0.5%)	1	0/210 (0%)	0
Hepatobiliary disorders
Cholelithiasis	2/212 (0.9%)	2	0/210 (0%)	0
Infections and infestations
Epiglottitis	1/212 (0.5%)	1	0/210 (0%)	0
Appendicitis	0/212 (0%)	0	2/210 (1%)	2
Sepsis	0/212 (0%)	0	1/210 (0.5%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/212 (0.5%)	1	0/210 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer	1/212 (0.5%)	1	0/210 (0%)	0
Breast Cancer in situ	1/212 (0.5%)	1	0/210 (0%)	0
Ovarian Cancer	1/212 (0.5%)	1	0/210 (0%)	0
Thyroid Cancer	1/212 (0.5%)	1	0/210 (0%)	0
Skin and subcutaneous tissue disorders
Hidradenitis	0/212 (0%)	0	1/210 (0.5%)	1
Vascular disorders
Aortic aneurysm	0/212 (0%)	0	1/210 (0.5%)	1
Other (Not Including Serious) Adverse Events
	Lira 3.0 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	177/212 (83.5%)		163/210 (77.6%)
Gastrointestinal disorders
Nausea	101/212 (47.6%)	181	36/210 (17.1%)	55
Constipation	57/212 (26.9%)	66	26/210 (12.4%)	28
Diarrhoea	38/212 (17.9%)	53	26/210 (12.4%)	34
Vomiting	35/212 (16.5%)	44	5/210 (2.4%)	6
Dyspepsia	20/212 (9.4%)	25	4/210 (1.9%)	4
Abdominal Pain	14/212 (6.6%)	17	3/210 (1.4%)	4
Abdominal Distension	13/212 (6.1%)	14	8/210 (3.8%)	9
Eructation	11/212 (5.2%)	17	0/210 (0%)	0
Flatulence	11/212 (5.2%)	17	8/210 (3.8%)	8
General disorders
Injection Site Haematoma	17/212 (8%)	18	24/210 (11.4%)	32
Fatigue	17/212 (8%)	20	11/210 (5.2%)	12
Injection Site Pain	8/212 (3.8%)	9	11/210 (5.2%)	11
Infections and infestations
Nasopharyngitis	36/212 (17%)	44	47/210 (22.4%)	63
Sinusitis	16/212 (7.5%)	17	27/210 (12.9%)	33
Upper Respiratory Tract Infection	26/212 (12.3%)	35	23/210 (11%)	33
Influenza	15/212 (7.1%)	17	22/210 (10.5%)	25
Urinary Tract Infection	15/212 (7.1%)	17	11/210 (5.2%)	11
Bronchitis	7/212 (3.3%)	7	11/210 (5.2%)	15
Injury, poisoning and procedural complications
Muscle Strain	11/212 (5.2%)	13	10/210 (4.8%)	11
Metabolism and nutrition disorders
Decreased Appetite	21/212 (9.9%)	22	3/210 (1.4%)	4
Hypoglycaemia	11/212 (5.2%)	18	5/210 (2.4%)	7
Musculoskeletal and connective tissue disorders
Back Pain	11/212 (5.2%)	12	20/210 (9.5%)	23
Arthralgia	12/212 (5.7%)	13	13/210 (6.2%)	13
Nervous system disorders
Headache	27/212 (12.7%)	42	26/210 (12.4%)	37
Dizziness	22/212 (10.4%)	35	18/210 (8.6%)	22
Respiratory, thoracic and mediastinal disorders
Cough	14/212 (6.6%)	15	11/210 (5.2%)	12

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Novo Nordisk reserves the right to not release data until specified milestones, e.g. a clinical trial report is available, including right to not release interim trial results, because this may lead to conclusions later shown to be incorrect. At trial end, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for a short time to protect intellectual property.

Results Point of Contact

Name/Title	Public Access to Clinical Trials
Organization	Novo Nordisk A/S
Phone
Email	clinicaltrials@novonordisk.com

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT00781937

Other Study ID Numbers:

NN8022-1923

First Posted:

Oct 29, 2008

Last Update Posted:

Nov 1, 2017

Last Verified:

Sep 1, 2017

Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE - Maintenance

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

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Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats