Trial Outcomes & Findings for Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes (NCT NCT05040971)

NCT ID: NCT05040971

Last Updated: 2026-01-29

Results Overview

Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 207 participants
• Primary outcome timeframe: From randomisation (week 0) to end of treatment (week 52)
• Results posted on: 2026-01-29

Participant Flow

The trial was conducted at 30 sites in 5 countries as follows: Canada (15 sites), Denmark (2 sites), Finland (2 sites), Spain (3 sites) and United Kingdom (8 sites).

The trial has a Main phase and Extension phase. Main phase: a 52-week treatment period (16 weeks of dose escalation and 36 weeks of maintenance dose). Extension phase: a 28-week off-treatment extension phase after the main phase for assessment of body weight, glycaemic and cardiovascular parameters. Participants were randomised in 2:1 ratio either to receive semaglutide 2.4 mg or placebo as an adjunct to a reduced-calorie diet and increased physical activity.

Participant milestones

Measure	Semaglutide 2.4 mg Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Study STARTED	138	69
Overall Study Full Analysis Set (FAS)	138	69
Overall Study Safety Analysis Set (SAS)	138	69
Overall Study COMPLETED	128	64
Overall Study NOT COMPLETED	10	5

Reasons for withdrawal

Measure	Semaglutide 2.4 mg Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Overall Study Lost to Follow-up	8	3
Overall Study Death	2	0
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes

Baseline characteristics by cohort

Measure	Semaglutide 2.4 mg n=138 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=69 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Total n=207 Participants Total of all reporting groups
Age, Continuous	53 Years STANDARD_DEVIATION 11 • n=35 Participants	53 Years STANDARD_DEVIATION 11 • n=4328 Participants	53 Years STANDARD_DEVIATION 11 • n=8687 Participants
Sex: Female, Male Female	100 Participants n=35 Participants	47 Participants n=4328 Participants	147 Participants n=8687 Participants
Sex: Female, Male Male	38 Participants n=35 Participants	22 Participants n=4328 Participants	60 Participants n=8687 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=35 Participants	1 Participants n=4328 Participants	7 Participants n=8687 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	132 Participants n=35 Participants	68 Participants n=4328 Participants	200 Participants n=8687 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race/Ethnicity, Customized White	124 Participants n=35 Participants	59 Participants n=4328 Participants	183 Participants n=8687 Participants
Race/Ethnicity, Customized Asian	4 Participants n=35 Participants	5 Participants n=4328 Participants	9 Participants n=8687 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=35 Participants	3 Participants n=4328 Participants	9 Participants n=8687 Participants
Race/Ethnicity, Customized Other	4 Participants n=35 Participants	1 Participants n=4328 Participants	5 Participants n=8687 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=35 Participants	1 Participants n=4328 Participants	1 Participants n=8687 Participants

PRIMARY outcome

Timeframe: From randomisation (week 0) to end of treatment (week 52)

Population: Full analysis set (FAS) included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=129 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=66 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Weight (Percentage [%])	-14.4 Percentage (%) of body weight Standard Deviation 7.9	-2.7 Percentage (%) of body weight Standard Deviation 4.3

PRIMARY outcome

Timeframe: At week 52

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: glycosylated haemoglobin (HbA1c) lesser than (<) 6.0 percentage (%) and fasting plasma glucose (FPG) lesser than (<) 5.5 millimoles per liter (mmol/L). 2) Pre-diabetes: 6.0% lesser than or equal (≤) HbA1c lesser than (<) 6.5% or 5.5 mmol/L lesser than or equal (≤) FPG lesser than (<) 7.0 mmol/L or non-verified type 2 diabetes. 3) Type 2 diabetes: HbA1c greater than or equal (≥) 6.5% or FPG greater than or equal (≥) 7.0 mmol/L.

Outcome measures

Measure	Semaglutide 2.4 mg n=127 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=64 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants With Change to Normoglycemia Normoglycemia	103 Participants	9 Participants
Participants With Change to Normoglycemia Pre-diabetes	23 Participants	53 Participants
Participants With Change to Normoglycemia Type 2 diabetes	1 Participants	2 Participants

SECONDARY outcome

Timeframe: From randomisation (week 0) to end of treatment (week 52)

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Change in glycosylated haemoglobin (HbA1c) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=129 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=63 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Glycosylated Haemoglobin (HbA1c)	-0.4 Percentage of HbA1c Standard Deviation 0.3	0.1 Percentage of HbA1c Standard Deviation 0.2

SECONDARY outcome

Timeframe: From randomisation (week 0) to end of treatment (week 52)

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Change in fasting plasma glucose (FPG) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=127 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=63 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Fasting Plasma Glucose (FPG)	-0.8 millimoles per liter (mmol/L) Standard Deviation 0.6	-0.3 millimoles per liter (mmol/L) Standard Deviation 0.7

SECONDARY outcome

Timeframe: From randomisation (week 0) to end of treatment (week 52)

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Change in waist circumference from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=129 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=66 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Waist Circumference	-11.6 centimeter (cm) Standard Deviation 8.7	-2.8 centimeter (cm) Standard Deviation 5.4

SECONDARY outcome

Timeframe: From randomisation (week 0) to end of treatment (week 52)

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Change in systolic blood pressure from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=129 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=66 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Systolic Blood Pressure	-9 millimeters of mercury (mmHg) Standard Deviation 13	-1 millimeters of mercury (mmHg) Standard Deviation 13

SECONDARY outcome

Timeframe: From randomisation (week 0) to end of treatment (week 52)

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Change in triglycerides (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=126 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=62 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline	0.80 Ratio of triglycerides Geometric Coefficient of Variation 36.4	0.96 Ratio of triglycerides Geometric Coefficient of Variation 30.6

SECONDARY outcome

Timeframe: From randomisation (week 0) to end of treatment (week 52)

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Change in total cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=127 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=63 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Total Cholesterol (mmol/L) - Ratio to Baseline	0.94 Ratio of total cholesterol Geometric Coefficient of Variation 16.1	1.01 Ratio of total cholesterol Geometric Coefficient of Variation 15.7

SECONDARY outcome

Timeframe: From randomisation (week 0) to end of treatment (week 52)

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Change in high density lipoprotein (HDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=119 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=61 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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	1.02 Ratio of HDL cholesterol Geometric Coefficient of Variation 12.4	0.99 Ratio of HDL cholesterol Geometric Coefficient of Variation 11.7

SECONDARY outcome

Timeframe: From randomisation (week 0) to end of treatment (week 52)

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Change in low density lipoprotein (LDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=118 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=61 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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	0.93 Ratio of LDL cholesterol Geometric Coefficient of Variation 26.6	1.03 Ratio of LDL cholesterol Geometric Coefficient of Variation 23.6

SECONDARY outcome

Timeframe: From randomisation (week 0) to end of treatment (week 52)

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Change in very low density lipoprotein (VLDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=125 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=62 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. 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	0.80 Ratio of VLDL cholesterol Geometric Coefficient of Variation 36.5	0.96 Ratio of VLDL cholesterol Geometric Coefficient of Variation 30.7

SECONDARY outcome

Timeframe: From randomisation (week 0) to week 52

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=129 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=66 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Body Weight (Kilogram [Kg])	-15.8 kilogram (Kg) Standard Deviation 9.3	-2.8 kilogram (Kg) Standard Deviation 5.0

SECONDARY outcome

Timeframe: At week 52

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Participants who achieved body weight reduction greater than or equal to 5% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=129 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=66 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No) Yes	111 Participants	17 Participants
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No) No	18 Participants	49 Participants

SECONDARY outcome

Timeframe: At week 52

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Participants who achieved body weight reduction greater than or equal to 10% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=129 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=66 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No) Yes	95 Participants	5 Participants
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No) No	34 Participants	61 Participants

SECONDARY outcome

Timeframe: At week 52

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Participants who achieved body weight reduction greater than or equal to 15% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=129 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=66 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No) Yes	62 Participants	1 Participants
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No) No	67 Participants	65 Participants

SECONDARY outcome

Timeframe: At week 52

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Participants who achieved body weight reduction greater than or equal to 20% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=129 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=66 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No) Yes	32 Participants	0 Participants
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No) No	97 Participants	66 Participants

SECONDARY outcome

Timeframe: From randomisation (week 0) to end of treatment (week 52)

Population: FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.

Change in pulse from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

Outcome measures

Measure	Semaglutide 2.4 mg n=128 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=66 Participants Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Change in Pulse	2 beats per minute (bpm) Standard Deviation 10	0 beats per minute (bpm) Standard Deviation 7

Adverse Events

Semaglutide 2.4 mg

Serious events: 12 serious events

Other events: 93 other events

Deaths: 2 deaths

Placebo

Serious events: 6 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Semaglutide 2.4 mg n=138 participants at risk Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=69 participants at risk Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Cardiac disorders Acute myocardial infarction	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic thyroid cancer	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Cardiac disorders Angina pectoris	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Cardiac disorders Atrial fibrillation	0.00% 0/138 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	1.4% 1/69 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Cardiac disorders Atrial flutter	0.00% 0/138 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	1.4% 1/69 • Number of events 3 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Product Issues Embedded device	0.00% 0/138 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	1.4% 1/69 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Eye disorders Cataract	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
General disorders Chest pain	0.00% 0/138 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	1.4% 1/69 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Hepatobiliary disorders Cholelithiasis	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Injury, poisoning and procedural complications Concussion	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Gastrointestinal disorders Diarrhoea	0.72% 1/138 • Number of events 2 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Infections and infestations Endophthalmitis	0.00% 0/138 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	1.4% 1/69 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Injury, poisoning and procedural complications Facial bones fracture	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Infections and infestations Gastroenteritis	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Vascular disorders Hypertension	0.00% 0/138 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	1.4% 1/69 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Injury, poisoning and procedural complications Ligament sprain	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/138 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	1.4% 1/69 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Infections and infestations Mastitis	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Gastrointestinal disorders Nausea	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Gastrointestinal disorders Pancreatitis	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Gastrointestinal disorders Pancreatitis acute	1.4% 2/138 • Number of events 3 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Infections and infestations Pilonidal disease	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
General disorders Pyrexia	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Reproductive system and breast disorders Rectocele	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Infections and infestations Submandibular abscess	0.00% 0/138 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	1.4% 1/69 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Cardiac disorders Tachycardia	0.00% 0/138 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	1.4% 1/69 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Gastrointestinal disorders Vomiting	0.72% 1/138 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.

Other adverse events

Measure	Semaglutide 2.4 mg n=138 participants at risk Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	Placebo n=69 participants at risk Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
Gastrointestinal disorders Abdominal pain upper	5.1% 7/138 • Number of events 8 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	5.8% 4/69 • Number of events 4 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Infections and infestations COVID-19	34.8% 48/138 • Number of events 55 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	30.4% 21/69 • Number of events 21 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Gastrointestinal disorders Constipation	18.1% 25/138 • Number of events 29 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Metabolism and nutrition disorders Decreased appetite	8.0% 11/138 • Number of events 11 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	1.4% 1/69 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Gastrointestinal disorders Diarrhoea	12.3% 17/138 • Number of events 31 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	10.1% 7/69 • Number of events 7 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Nervous system disorders Dizziness	5.1% 7/138 • Number of events 7 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	1.4% 1/69 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Gastrointestinal disorders Dyspepsia	8.7% 12/138 • Number of events 21 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	4.3% 3/69 • Number of events 4 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.1% 7/138 • Number of events 8 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	0.00% 0/69 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Nervous system disorders Headache	4.3% 6/138 • Number of events 8 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	7.2% 5/69 • Number of events 6 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Infections and infestations Nasopharyngitis	5.1% 7/138 • Number of events 7 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	2.9% 2/69 • Number of events 2 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Gastrointestinal disorders Nausea	29.0% 40/138 • Number of events 50 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	4.3% 3/69 • Number of events 3 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.
Gastrointestinal disorders Vomiting	11.6% 16/138 • Number of events 27 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.	1.4% 1/69 • Number of events 1 • From randomisation (week 0) to week 57 All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set (SAS) during on-treatment included all participants randomly assigned to treatment who took at least one dose of study product.

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