Trial Outcomes & Findings for Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE

Results Overview

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

422 participants

Primary outcome timeframe

Week 0, week 56

Results posted on

2017-11-01

Participant Flow

The trial was conducted at 26 sites in the United States and 10 sites in Canada.

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.

Participant milestones

Participant milestones
Measure	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	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
Main Trial Period Through Week 56 STARTED	212	210
Main Trial Period Through Week 56 COMPLETED	159	146
Main Trial Period Through Week 56 NOT COMPLETED	53	64
Follow up Period (Week 56-68) STARTED	159	146
Follow up Period (Week 56-68) COMPLETED	153	141
Follow up Period (Week 56-68) NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Main Trial Period Through Week 56 Adverse Event	18	18
Main Trial Period Through Week 56 Lack of Efficacy	0	2
Main Trial Period Through Week 56 Protocol Violation	8	5
Main Trial Period Through Week 56 Withdrawal by Subject	17	24
Main Trial Period Through Week 56 Unclassified	10	15
Follow up Period (Week 56-68) Protocol Violation	1	1
Follow up Period (Week 56-68) Unclassified	5	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lira 3.0 mg n=212 Participants 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	Placebo n=210 Participants 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 n=422 Participants Total of all reporting groups
Age, Continuous	45.9 years STANDARD_DEVIATION 11.9 • n=5 Participants	46.5 years STANDARD_DEVIATION 11.0 • n=7 Participants	46.2 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	178 Participants n=5 Participants	165 Participants n=7 Participants	343 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	45 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	195 Participants n=5 Participants	199 Participants n=7 Participants	394 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	32 Participants n=5 Participants	24 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) White	170 Participants n=5 Participants	185 Participants n=7 Participants	355 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	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Co-morbidity status Present	94 participants n=5 Participants	96 participants n=7 Participants	190 participants n=5 Participants
Co-morbidity status Absent	118 participants n=5 Participants	114 participants n=7 Participants	232 participants n=5 Participants
Co-morbidity status and Body Mass Index (BMI) Present and BMI (27-30) kg/m^2	3 participants n=5 Participants	6 participants n=7 Participants	9 participants n=5 Participants
Co-morbidity status and Body Mass Index (BMI) Present and BMI >=30 kg/m^2	91 participants n=5 Participants	90 participants n=7 Participants	181 participants n=5 Participants
Co-morbidity status and Body Mass Index (BMI) Absent and BMI >=30 kg/m^2	118 participants n=5 Participants	114 participants n=7 Participants	232 participants n=5 Participants
Smoking Yes	20 participants n=5 Participants	22 participants n=7 Participants	42 participants n=5 Participants
Smoking No	192 participants n=5 Participants	188 participants n=7 Participants	380 participants n=5 Participants
Height	1.67 meters STANDARD_DEVIATION 0.09 • n=5 Participants	1.67 meters STANDARD_DEVIATION 0.09 • n=7 Participants	1.67 meters STANDARD_DEVIATION 0.09 • n=5 Participants
Weight at screening	106.7 kg STANDARD_DEVIATION 21.8 • n=5 Participants	105.0 kg STANDARD_DEVIATION 22.4 • n=7 Participants	105.9 kg STANDARD_DEVIATION 22.1 • n=5 Participants
Weight at randomisation	100.4 kg STANDARD_DEVIATION 20.8 • n=5 Participants	98.7 kg STANDARD_DEVIATION 21.2 • n=7 Participants	99.6 kg STANDARD_DEVIATION 21.0 • n=5 Participants
Body Mass Index (BMI) at screening	38.2 kg/m^2 STANDARD_DEVIATION 6.2 • n=5 Participants	37.5 kg/m^2 STANDARD_DEVIATION 6.2 • n=7 Participants	37.9 kg/m^2 STANDARD_DEVIATION 6.2 • n=5 Participants
Body Mass Index (BMI) group (kg/m^2) at screening 27-30	3 participants n=5 Participants	6 participants n=7 Participants	9 participants n=5 Participants
Body Mass Index (BMI) group (kg/m^2) at screening 30-35	69 participants n=5 Participants	80 participants n=7 Participants	149 participants n=5 Participants
Body Mass Index (BMI) group (kg/m^2) at screening 35-40	69 participants n=5 Participants	58 participants n=7 Participants	127 participants n=5 Participants
Body Mass Index (BMI) group (kg/m^2) at screening Greater than or equal to 40	71 participants n=5 Participants	66 participants n=7 Participants	137 participants n=5 Participants
Body Mass Index (BMI) at randomisation	36.0 kg/m^2 STANDARD_DEVIATION 5.9 • n=5 Participants	35.2 kg/m^2 STANDARD_DEVIATION 5.9 • n=7 Participants	35.6 kg/m^2 STANDARD_DEVIATION 5.9 • n=5 Participants

PRIMARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=194 Participants 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	Placebo n=188 Participants 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
Mean Percentage Change in Fasting Body Weight From Baseline	-6.11 percentage Standard Error 0.66	-0.05 percentage Standard Error 0.63

PRIMARY outcome

Timeframe: Week 0, week 56

Population: 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.)

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.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=194 Participants 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	Placebo n=188 Participants 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
Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0	80.8 percentage of subjects	47.9 percentage of subjects

PRIMARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=194 Participants 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	Placebo n=188 Participants 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
Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0	50.5 percentage of subjects	21.9 percentage of subjects

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=194 Participants 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	Placebo n=188 Participants 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
Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0	26.1 percentage of subjects	6.3 percentage of subjects

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=207 Participants 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	Placebo n=206 Participants 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
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0	1.9 percentage of subjects	17.5 percentage of subjects

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=207 Participants 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	Placebo n=206 Participants 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
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0	0 percentage of subjects	2.9 percentage of subjects

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=207 Participants 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	Placebo n=206 Participants 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
Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0	93.2 percentage of subjects	70.9 percentage of subjects

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=207 Participants 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	Placebo n=206 Participants 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
Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0	87.4 percentage of subjects	54.4 percentage of subjects

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=194 Participants 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	Placebo n=188 Participants 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
Change From Baseline in Fasting Weight	-5.7 kg Standard Error 0.66	0.16 kg Standard Error 0.63

SECONDARY outcome

Timeframe: Week 0, week 68

Population: 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.)

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=159 Participants 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	Placebo n=144 Participants 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
Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period	-3.83 kg Standard Error 0.82	0.41 kg Standard Error 0.78

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=207 Participants 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	Placebo n=206 Participants 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
Change From Baseline in Blood Pressure Change in Systolic Blood Pressure	1.31 mmHg Standard Error 0.90	4.03 mmHg Standard Error 0.87
Change From Baseline in Blood Pressure Change in Diastolic Blood Pressure	1.81 mmHg Standard Error 0.64	2.15 mmHg Standard Error 0.61

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=207 Participants 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	Placebo n=206 Participants 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
Change From Baseline in Pulse	4.12 beats/minute Standard Error 0.68	3.15 beats/minute Standard Error 0.65

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=194 Participants 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	Placebo n=187 Participants 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
Change From Baseline in Fasting Lipid Profile: Triglycerides	0.02 mmol/L Standard Error 0.04	0.12 mmol/L Standard Error 0.04

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=194 Participants 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	Placebo n=187 Participants 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
Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol	0.24 mmol/L Standard Error 0.05	0.33 mmol/L Standard Error 0.05

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=194 Participants 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	Placebo n=187 Participants 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
Change From Baseline in Fasting Lipid Profile: Total Cholesterol	0.22 mmol/L Standard Error 0.06	0.33 mmol/L Standard Error 0.06

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=185 Participants 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	Placebo n=174 Participants 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
Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)	-11.31 nmol/L Standard Error 4.62	1.70 nmol/L Standard Error 4.51

SECONDARY outcome

Timeframe: Week 56

Population: 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.)

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.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=194 Participants 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	Placebo n=188 Participants 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
Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56	31.4 percentage of subjects	36.7 percentage of subjects

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=207 Participants 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	Placebo n=206 Participants 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
Change From Baseline in Waist Circumference	-4.36 cm Standard Error 0.62	-0.86 cm Standard Error 0.59

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=207 Participants 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	Placebo n=206 Participants 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
Change From Baseline in Body Mass Index (BMI)	-1.90 kg/m^2 Standard Error 0.22	0.15 kg/m^2 Standard Error 0.21

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

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%.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=190 Participants 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	Placebo n=181 Participants 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
Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)	8.51 percent change Standard Error 2.33	6.16 percent change Standard Error 2.27

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

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.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=190 Participants 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	Placebo n=181 Participants 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
Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)	-0.01 proportion Standard Error 0.03	0.08 proportion Standard Error 0.03

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=194 Participants 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	Placebo n=188 Participants 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
Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)	-0.52 mmol/L Standard Error 0.05	-0.14 mmol/L Standard Error 0.05

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=194 Participants 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	Placebo n=188 Participants 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
Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin	0.50 pmol/L Standard Error 0.67	2.35 pmol/L Standard Error 0.65

SECONDARY outcome

Timeframe: Week 0, week 56

Population: 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.)

Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated \[X% - Y%\].

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=194 Participants 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	Placebo n=188 Participants 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
Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)	-0.14 percentage point Standard Error 0.03	0.13 percentage point Standard Error 0.03

SECONDARY outcome

Timeframe: Week 0 and week 56

Population: 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.)

Number of subjects using concomitant medications at Week 0 and Week 56, respectively

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=207 Participants 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	Placebo n=206 Participants 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
Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications) Antihypertensive drug - Week 0	65 Subjects	66 Subjects
Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications) Antihypertensive drug - Week 56	63 Subjects	63 Subjects
Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications) Antipsychotic drug - Week 0	18 Subjects	25 Subjects
Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications) Antipsychotic drug - Week 56	20 Subjects	29 Subjects
Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications) Lipid lowering drug - Week 0	45 Subjects	45 Subjects
Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications) Lipid lowering drug - Week 56	52 Subjects	50 Subjects

SECONDARY outcome

Timeframe: Week 0, week 50 and week 57

Population: 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.)

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)

Outcome measures

Outcome measures
Measure	Lira 3.0 mg n=207 Participants 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	Placebo n=206 Participants 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
Binge Eating Scale Scores by Week and Severity Week 0, baseline	7.8 scores on a scale Standard Deviation 5.6	7.8 scores on a scale Standard Deviation 6.2
Binge Eating Scale Scores by Week and Severity Week 50	6.6 scores on a scale Standard Deviation 5.6	8.6 scores on a scale Standard Deviation 7.0
Binge Eating Scale Scores by Week and Severity Week 57	6.6 scores on a scale Standard Deviation 5.8	6.9 scores on a scale Standard Deviation 6.2

Adverse Events

Lira 3.0 mg

Serious events: 9 serious events

Other events: 177 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 163 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lira 3.0 mg n=212 participants at risk 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	Placebo n=210 participants at risk 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
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.47% 1/212 • Number of events 1 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.	0.00% 0/210 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer in situ	0.47% 1/212 • Number of events 1 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.	0.00% 0/210 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer	0.47% 1/212 • Number of events 1 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.	0.00% 0/210 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Cancer	0.47% 1/212 • Number of events 1 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.	0.00% 0/210 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.
Hepatobiliary disorders Cholelithiasis	0.94% 2/212 • Number of events 2 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.	0.00% 0/210 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.
Gastrointestinal disorders Colitis Ischaemic	0.47% 1/212 • Number of events 1 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.	0.00% 0/210 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.
Infections and infestations Epiglottitis	0.47% 1/212 • Number of events 1 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.	0.00% 0/210 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.
Infections and infestations Appendicitis	0.00% 0/212 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.	0.95% 2/210 • Number of events 2 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.
Infections and infestations Sepsis	0.00% 0/212 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.	0.48% 1/210 • Number of events 1 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.
Musculoskeletal and connective tissue disorders Arthralgia	0.47% 1/212 • Number of events 1 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.	0.00% 0/210 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.
Cardiac disorders Cardiac Failure	0.00% 0/212 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.	0.48% 1/210 • Number of events 1 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/212 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.	0.48% 1/210 • Number of events 1 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.
Vascular disorders Aortic aneurysm	0.00% 0/212 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.	0.48% 1/210 • Number of events 1 • 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. Safety analysis set were all randomised subjects who had been exposed to at least one dose of trial product.

Other adverse events

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Novo Nordisk A/S

Email: [email protected]

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Principal investigator is a sponsor employee 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.
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Trial Outcomes & Findings for Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE - Maintenance (NCT NCT00781937)

Results Overview

Participant Flow

Participant milestones

Reasons for withdrawal

Baseline Characteristics

Baseline characteristics by cohort

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Adverse Events

Lira 3.0 mg

Placebo

Serious adverse events

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Additional Information

Public Access to Clinical Trials

Results disclosure agreements