Trial Outcomes & Findings for A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity (NCT NCT04102189)

NCT ID: NCT04102189

Last Updated: 2025-12-11

Results Overview

Change in BMI (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 201 participants
• Primary outcome timeframe: Baseline (week 0), week 68
• Results posted on: 2025-12-11

Participant Flow

The trial was conducted at 37 sites in 8 countries, as follows: Austria (3), Belgium (4), Croatia (3), Ireland (1), Mexico (1), Russia (7), Great Britain (6), United States (12).

Participants were randomized 2:1 to receive either semaglutide subcutaneously (s.c.) once weekly or semaglutide placebo s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks. This was followed by a 7-week follow-up period after 'end of treatment' due to the long half-life of semaglutide.

Participant milestones

Measure	Semaglutide 2.4 mg Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Study STARTED	134	67
Overall Study Treated	133	67
Overall Study Full Analysis Set (FAS)	134	67
Overall Study Safety Analysis Set	133	67
Overall Study COMPLETED	132	64
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Semaglutide 2.4 mg Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Study Withdrawal by Subject	1	2
Overall Study Withdrawal by parent/guardian	0	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

Baseline characteristics by cohort

Measure	Semaglutide 2.4 mg n=134 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=67 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Total n=201 Participants Total of all reporting groups
Age, Continuous	15.5 Years STANDARD_DEVIATION 1.5 • n=237 Participants	15.3 Years STANDARD_DEVIATION 1.6 • n=243 Participants	15.4 Years STANDARD_DEVIATION 1.6 • n=480 Participants
Sex: Female, Male Female	84 Participants n=237 Participants	41 Participants n=243 Participants	125 Participants n=480 Participants
Sex: Female, Male Male	50 Participants n=237 Participants	26 Participants n=243 Participants	76 Participants n=480 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=237 Participants	8 Participants n=243 Participants	22 Participants n=480 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	120 Participants n=237 Participants	59 Participants n=243 Participants	179 Participants n=480 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=237 Participants	0 Participants n=243 Participants	0 Participants n=480 Participants
Race/Ethnicity, Customized Race · White	104 Participants n=237 Participants	55 Participants n=243 Participants	159 Participants n=480 Participants
Race/Ethnicity, Customized Race · Other	14 Participants n=237 Participants	6 Participants n=243 Participants	20 Participants n=480 Participants
Race/Ethnicity, Customized Race · Black or African American	11 Participants n=237 Participants	5 Participants n=243 Participants	16 Participants n=480 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=237 Participants	1 Participants n=243 Participants	4 Participants n=480 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	2 Participants n=237 Participants	0 Participants n=243 Participants	2 Participants n=480 Participants

PRIMARY outcome

Timeframe: Baseline (week 0), week 68

Population: The full analysis set (FAS) included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in BMI (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=62 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=131 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Mass Index (BMI) (Percentage [%])	-0.1 Percentage change of BMI Standard Deviation 8.6	-16.2 Percentage change of BMI Standard Deviation 12.9

SECONDARY outcome

Timeframe: At week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Percentage of participants who achieved >= 5% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved >= 5% weight reduction, whereas 'No' infers the percentage of participants who did not achieve >= 5% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=62 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=131 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no) Yes	17.7 Percentage of participants	72.5 Percentage of participants
Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no) No	82.3 Percentage of participants	27.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in body weight (kg) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=62 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=131 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Weight (Kilograms [kg])	2.3 kg Standard Deviation 9.7	-15.7 kg Standard Deviation 14.6

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in body weight (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=62 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=131 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Weight (%)	2.3 Percentage change of body weight Standard Deviation 9.1	-14.8 Percentage change of body weight Standard Deviation 13.2

SECONDARY outcome

Timeframe: At week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Percentage of participants who achieved >= 10% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved >= 10% weight reduction, whereas 'No' infers the percentage of participants who did not achieve >= 10% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=62 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=131 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no) Yes	8.1 Percentage of participants	61.8 Percentage of participants
Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no) No	91.9 Percentage of participants	38.2 Percentage of participants

SECONDARY outcome

Timeframe: At week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Percentage of participants who achieved >= 15% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved >= 15% weight reduction, whereas 'No' infers the percentage of participants who did not achieve >= 15% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=62 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=131 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no) No	95.2 Percentage of participants	46.6 Percentage of participants
Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no) Yes	4.8 Percentage of participants	53.4 Percentage of participants

SECONDARY outcome

Timeframe: At week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Percentage of participants who achieved >= 20% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved >= 20% weight reduction, whereas 'No' infers the percentage of participants who did not achieve >= 20% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=62 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=131 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no) Yes	3.2 Percentage of participants	37.4 Percentage of participants
Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no) No	96.8 Percentage of participants	62.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change from baseline in BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov) at week 68 is presented. CDC gender and age-specific growth charts: normal (BMI less than [<] 85th percentile), overweight (BMI greater than or equal to [>=] 85th - <95th percentile), obesity class I (BMI >=95th - <120% of the 95th percentile), obesity class II (BMI >=120% of the 95th percentile - <140% of the 95th percentile) and obesity class III (BMI >=140% of the 95th percentile). Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=62 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=131 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in BMI Percentage of the 95th Percentile on Gender and Age-specific Growth Charts (CDC.Gov [CDC: {Centers for Disease Control and Prevention}])	-4.5 Percentage point of BMI Standard Deviation 10.5	-24.9 Percentage point of BMI Standard Deviation 17.0

SECONDARY outcome

Timeframe: At week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Percentage of participants who achieved improvement in weight category from baseline (week 0) to week 68 is presented. Improvement in weight category was defined as being in a lower weight category at week 68 compared to baseline according to CDC gender and age-specific growth charts: normal (BMI <85th percentile), overweight (BMI >=85th - <95th percentile), obesity class I (BMI >=95th - <120% of the 95th percentile), obesity class II (BMI >=120% of the 95th percentile - <140% of the 95th percentile) and obesity class III (BMI >=140% of the 95th percentile). In the reported data, 'Yes' infers the percentage of participants who have achieved improvement in weight category, whereas 'No' infers the percentage of participants who did not achieve improvement in weight category. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

Outcome measures

Measure	Placebo n=62 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=131 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Percentage of Participants Achieving Improvement in Weight Category (Yes/no) Yes	21.0 Percentage of participants	71.8 Percentage of participants
Percentage of Participants Achieving Improvement in Weight Category (Yes/no) No	79.0 Percentage of participants	28.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in BMI SDS from baseline to week 68 is presented. The SDS scores are also called as z-scores. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. Possible values range from -3 to +3, a negative score being beneficial. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=62 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=131 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in BMI (Standard Deviation Score [SDS])	-0.1 standard deviation score Standard Deviation 0.5	-1.1 standard deviation score Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in BMI (kg/m^2) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=62 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=131 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in BMI (Kilograms Per Meter Square [kg/m^2])	0.0 kg/m^2 Standard Deviation 3.1	-5.9 kg/m^2 Standard Deviation 4.9

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in waist circumference (centimeters [cm]) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=62 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=131 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Waist Circumference	-0.5 cm Standard Deviation 6.5	-12.7 cm Standard Deviation 12.2

SECONDARY outcome

Timeframe: At week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Percentage of participants who achieved >= 5% reduction of BMI from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved >= 5% BMI reduction, whereas 'No' infers the percentage of participants who did not achieve >= 5% BMI reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=62 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=131 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no) Yes	22.6 Percentage of participants	75.6 Percentage of participants
Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no) No	77.4 Percentage of participants	24.4 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in systolic blood pressure from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=62 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=131 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Systolic Blood Pressure	-1 millimeters of mercury (mmHg) Standard Deviation 9	-3 millimeters of mercury (mmHg) Standard Deviation 12

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in diastolic blood pressure from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=62 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=131 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Diastolic Blood Pressure	-1 mmHg Standard Deviation 8	-2 mmHg Standard Deviation 9

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in HbA1c (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=59 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=126 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Glycated Haemoglobin (HbA1c) (%)	-0.1 Percentage of HbA1c Standard Deviation 0.3	-0.4 Percentage of HbA1c Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in HbA1c (mmol/mol) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=59 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=126 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in HbA1c (Millimoles Per Mole [mmol/Mol])	-1.2 mmol/mol Standard Deviation 2.9	-4.2 mmol/mol Standard Deviation 3.5

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in fasting plasma glucose (mmol/L) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=57 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=127 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L])	0.0 mmol/L Standard Deviation 0.5	-0.2 mmol/L Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in fasting plasma glucose (mg/dL) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=57 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=127 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL])	0.0 mg/dL Standard Deviation 8.6	-4.2 mg/dL Standard Deviation 9.6

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in fasting insulin (pmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=51 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=120 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline	0.99 Ratio of fasting insulin Geometric Coefficient of Variation 58.2	0.64 Ratio of fasting insulin Geometric Coefficient of Variation 62.9

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in fasting insulin (mIU/mL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=51 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=120 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline	0.99 Ratio of fasting insulin Geometric Coefficient of Variation 58.2	0.64 Ratio of fasting insulin Geometric Coefficient of Variation 62.9

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in total cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=58 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=130 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Total Cholesterol (mmol/L): Ratio to Baseline	0.98 Ratio of total cholesterol Geometric Coefficient of Variation 9.4	0.92 Ratio of total cholesterol Geometric Coefficient of Variation 14.6

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in total cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=58 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=130 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Total Cholesterol (mg/dL): Ratio to Baseline	0.98 Ratio of total cholesterol Geometric Coefficient of Variation 9.4	0.92 Ratio of total cholesterol Geometric Coefficient of Variation 14.6

SECONDARY outcome

Timeframe: Baseline (week 0), week 68:

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in HDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=57 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=124 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L): Ratio to Baseline	1.03 Ratio of HDL cholesterol Geometric Coefficient of Variation 21.5	1.08 Ratio of HDL cholesterol Geometric Coefficient of Variation 17.5

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in HDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=57 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=124 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL): Ratio to Baseline	1.03 Ratio of HDL cholesterol Geometric Coefficient of Variation 21.5	1.08 Ratio of HDL cholesterol Geometric Coefficient of Variation 17.5

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in LDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=58 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=129 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L): Ratio to Baseline	0.96 Ratio of LDL cholesterol Geometric Coefficient of Variation 15.4	0.91 Ratio of LDL cholesterol Geometric Coefficient of Variation 20.9

SECONDARY outcome

Timeframe: Baseline (week 0), week 68:

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in LDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=58 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=129 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in LDL Cholesterol (mg/dL): Ratio to Baseline	0.96 Ratio of LDL cholesterol Geometric Coefficient of Variation 15.4	0.91 Ratio of LDL cholesterol Geometric Coefficient of Variation 20.9

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in VLDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=58 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=129 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L): Ratio to Baseline	1.03 Ratio of VLDL cholesterol Geometric Coefficient of Variation 40.8	0.71 Ratio of VLDL cholesterol Geometric Coefficient of Variation 46.1

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in VLDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=58 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=129 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in VLDL Cholesterol (mg/dL): Ratio to Baseline	1.03 Ratio of VLDL cholesterol Geometric Coefficient of Variation 40.8	0.71 Ratio of VLDL cholesterol Geometric Coefficient of Variation 46.1

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in triglycerides (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=58 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=129 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Triglycerides (mmol/L): Ratio to Baseline	1.04 Ratio of triglycerides Geometric Coefficient of Variation 40.9	0.71 Ratio of triglycerides Geometric Coefficient of Variation 45.8

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in triglycerides (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=58 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=129 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Triglycerides (mg/dL): Ratio to Baseline	1.04 Ratio of triglycerides Geometric Coefficient of Variation 40.9	0.71 Ratio of triglycerides Geometric Coefficient of Variation 45.8

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in ALT (units per liter [U/L]) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Outcome measures

Measure	Placebo n=58 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=128 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Alanine Aminotransferase (ALT): Ratio to Baseline	1.00 Ratio of ALT Geometric Coefficient of Variation 44.3	0.79 Ratio of ALT Geometric Coefficient of Variation 63.8

SECONDARY outcome

Timeframe: From baseline (week 0) to week 75

Population: The safety analysis set (SAS) included all randomized participants exposed to at least one dose of randomized treatment.

An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as greater than (>) 7 consecutive missed doses (corresponding to >7 weeks off-treatment).

Outcome measures

Measure	Placebo n=67 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=133 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Number of Treatment-emergent Adverse Events (TEAEs)	328 Events	792 Events

SECONDARY outcome

Timeframe: From baseline (week 0) to week 75

Population: SAS included all randomized participants exposed to at least one dose of randomized treatment.

An SAE is an AE that fulfils at least one of the following criteria: 1) results in death; 2) is life-threatening; 3) requires inpatient hospitalisation or prolongation of existing hospitalisation; 4) results in persistent disability/incapacity; 5) is a congenital anomaly/birth defect; 6) important medical event. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as >7 consecutive missed doses (corresponding to >7 weeks off-treatment).

Outcome measures

Measure	Placebo n=67 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=133 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Number of Treatment-emergent Serious Adverse Events (SAEs)	7 Events	17 Events

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: SAS included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in pulse from baseline to week 68 is presented. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

Outcome measures

Measure	Placebo n=58 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=119 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Pulse	-1 Beats per minute (beats/min) Standard Deviation 13	0 Beats per minute (beats/min) Standard Deviation 13

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: SAS included all randomized participants exposed to at least one dose of randomized treatment.

Change in amylase (U/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

Outcome measures

Measure	Placebo n=67 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=133 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Amylase: Ratio to Baseline	1.04 Ratio of amylase Geometric Coefficient of Variation 18.2	1.15 Ratio of amylase Geometric Coefficient of Variation 17.4

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: SAS included all randomized participants exposed to at least one dose of randomized treatment.

Change in lipase (U/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

Outcome measures

Measure	Placebo n=67 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=133 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Lipase: Ratio to Baseline	1.12 Ratio of lipase Geometric Coefficient of Variation 37.0	1.39 Ratio of lipase Geometric Coefficient of Variation 37.3

SECONDARY outcome

Timeframe: Baseline (week 0), week 68

Population: SAS included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.

Change in calcitonin (nanograms per liter [ng/L]) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

Outcome measures

Measure	Placebo n=55 Participants Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Semaglutide 2.4 mg n=116 Participants Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Calcitonin: Ratio to Baseline	1.09 Ratio of calcitonin Geometric Coefficient of Variation 36.7	1.14 Ratio of calcitonin Geometric Coefficient of Variation 47.0

Adverse Events

Semaglutide 2.4 mg

Serious events: 15 serious events

Other events: 90 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Measure	Semaglutide 2.4 mg n=133 participants at risk Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 mg of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=67 participants at risk Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Gastrointestinal disorders Abdominal pain	0.75% 1/133 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/67 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/133 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	1.5% 1/67 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Infections and infestations Appendicitis	1.5% 2/133 • Number of events 2 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/67 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Infections and infestations COVID-19	0.75% 1/133 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/67 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Infections and infestations COVID-19 pneumonia	0.75% 1/133 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/67 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Hepatobiliary disorders Cholecystitis acute	0.75% 1/133 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/67 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Hepatobiliary disorders Cholelithiasis	2.3% 3/133 • Number of events 3 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/67 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/133 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	1.5% 1/67 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/133 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	1.5% 1/67 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Psychiatric disorders Depression	0.75% 1/133 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/67 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Gastrointestinal disorders Gastritis	0.75% 1/133 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/67 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Hepatobiliary disorders Hepatic function abnormal	0.75% 1/133 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/67 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Nervous system disorders Loss of consciousness	0.00% 0/133 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	1.5% 1/67 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian germ cell teratoma benign	0.00% 0/133 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	1.5% 1/67 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Injury, poisoning and procedural complications Post procedural constipation	0.75% 1/133 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/67 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.75% 1/133 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/67 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Nervous system disorders Tension headache	0.00% 0/133 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	1.5% 1/67 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Investigations Transaminases increased	0.75% 1/133 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	1.5% 1/67 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Injury, poisoning and procedural complications Urinary retention postoperative	0.75% 1/133 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/67 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Gastrointestinal disorders Vomiting	0.75% 1/133 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/67 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.

Other adverse events

Measure	Semaglutide 2.4 mg n=133 participants at risk Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 mg of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=67 participants at risk Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Skin and subcutaneous tissue disorders Acne	3.0% 4/133 • Number of events 4 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	6.0% 4/67 • Number of events 4 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Gastrointestinal disorders Abdominal pain	15.0% 20/133 • Number of events 31 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	6.0% 4/67 • Number of events 4 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Gastrointestinal disorders Abdominal pain upper	8.3% 11/133 • Number of events 19 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	11.9% 8/67 • Number of events 11 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Investigations Blood creatine phosphokinase increased	0.75% 1/133 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	6.0% 4/67 • Number of events 4 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Infections and infestations COVID-19	11.3% 15/133 • Number of events 16 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	14.9% 10/67 • Number of events 10 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Gastrointestinal disorders Constipation	6.0% 8/133 • Number of events 8 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	1.5% 1/67 • Number of events 1 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Injury, poisoning and procedural complications Contusion	1.5% 2/133 • Number of events 2 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	6.0% 4/67 • Number of events 4 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Respiratory, thoracic and mediastinal disorders Cough	3.0% 4/133 • Number of events 5 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	6.0% 4/67 • Number of events 4 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Metabolism and nutrition disorders Decreased appetite	6.0% 8/133 • Number of events 8 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	4.5% 3/67 • Number of events 4 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Gastrointestinal disorders Diarrhoea	21.8% 29/133 • Number of events 54 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	19.4% 13/67 • Number of events 19 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Nervous system disorders Dizziness	7.5% 10/133 • Number of events 13 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	3.0% 2/67 • Number of events 3 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Reproductive system and breast disorders Dysmenorrhoea	1.5% 2/133 • Number of events 3 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	6.0% 4/67 • Number of events 7 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
General disorders Fatigue	3.0% 4/133 • Number of events 4 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	7.5% 5/67 • Number of events 5 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Infections and infestations Gastroenteritis	6.8% 9/133 • Number of events 9 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	3.0% 2/67 • Number of events 2 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Nervous system disorders Headache	16.5% 22/133 • Number of events 52 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	16.4% 11/67 • Number of events 20 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Infections and infestations Nasopharyngitis	12.0% 16/133 • Number of events 21 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	10.4% 7/67 • Number of events 12 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Gastrointestinal disorders Nausea	42.1% 56/133 • Number of events 127 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	17.9% 12/67 • Number of events 29 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
General disorders Pyrexia	3.8% 5/133 • Number of events 5 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	7.5% 5/67 • Number of events 5 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.
Gastrointestinal disorders Vomiting	36.1% 48/133 • Number of events 105 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.	10.4% 7/67 • Number of events 18 • From baseline (week 0) to week 75 All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). SAS included all randomized participants exposed to at least one dose of randomized treatment.

Additional Information

Clinical Reporting Office (2834)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: clinicaltrials@novonordisk.com

Results disclosure agreements

• Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
• Publication restrictions are in place

Restriction type: OTHER