Two-year Research Study Investigating How Well Semaglutid... | NCT03693430

ID	Type	Description	Link
2017-003726-32	Registry Identifier	European Medicines Agency (EudraCT)
U1111-1202-1740	Other Identifier	World Health Organization (WHO)

Label	Type	Description	Intervention Names
Semaglutide	Experimental	Participants will receive semaglutide 2.4 mg during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.	Drug: Semaglutide
Placebo	Placebo Comparator	Participants will receive placebo (semaglutide) during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.	Drug: Placebo (Semaglutide)

Name	Type	Description	Arm Group Labels	Other Names
Semaglutide	Drug	Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks

Measure	Description	Time Frame
Percentage Change From Baseline (Week 0) to Week 104 in Body Weight	Percentage change in body weight for both in-trial and on-treatment observation period from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: 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).	From Baseline (Week 0) to Week 104
Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%	Number of participants who achieved greater than or equal to (>=) 5% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=5% weight loss, whereas 'No' infers the number of participants who have not achieved >=5% weight loss. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: 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).	At Week 104

Measure	Description	Time Frame
Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%	Number of participants who achieved >=10% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=10% weight loss, whereas 'No' infers the number of participants who have not achieved >=10% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

Name	Affiliation	Role
Clinical Reporting Anchor and Disclosure (1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Birmingham	Alabama	35222	United States
Novo Nordisk Investigational Site

PubMed Identifier	Type	Citation	Retractions
32441473	Background	Kushner RF, Calanna S, Davies M, Dicker D, Garvey WT, Goldman B, Lingvay I, Thomsen M, Wadden TA, Wharton S, Wilding JPH, Rubino D. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020 Jun;28(6):1050-1061. doi: 10.1002/oby.22794.
36655300	Background

ID	Title	Description
FG000	Semaglutide 2.4 mg	Participants received once-weekly subcutaneous (s.c) injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 29, 2018	Feb 2, 2022

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage Change From Baseline (Week 0) to Week 104 in Body Weight

Percentage change in body weight for both in-trial and on-treatment observation period from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: 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).

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure and Number Analyzed = participants with available data for each specified category.

Posted

Mean

Standard Deviation

percentage change

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts
Participants	OG000144 OG001128

Title

Denominators

Categories

In-trial observation period

- ParticipantsOG000144
- ParticipantsOG001128

Title	Measurements
	OG000-15.9± 12.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Treatment policy estimand	ANCOVA		<.0001		Treatment difference	-12.55			2-Sided	95	-15.33	-9.77					Superiority	Week 104 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline body weight as covariate. Missing observations were multiple (x1000) imputed from retrieved subjects of the same randomised treatment arm.

Primary

Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%

Number of participants who achieved greater than or equal to (>=) 5% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=5% weight loss, whereas 'No' infers the number of participants who have not achieved >=5% weight loss. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: 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).

Posted

Count of Participants

Participants

At Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001

Secondary

Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%

Number of participants who achieved >=10% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=10% weight loss, whereas 'No' infers the number of participants who have not achieved >=10% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

At Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Secondary

Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%

Number of participants who achieved >=15% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=15% weight loss, whereas 'No' infers the number of participants who have not achieved >=15% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

At Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Secondary

Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%

Number of participants who achieved >=20% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=20% weight loss, whereas 'No' infers the number of participants who have not achieved >=20% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

At Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Secondary

Change From Baseline (Week 0) to Week 104 in Waist Circumference

Change in waist circumference from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

centimeter (cm)

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts

Secondary

Change From Baseline (Week 0) to Week 104 in Body Weight (kg)

Change in body weight from baseline (week 0) to week 104 in kilogram (kg) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

kilogram

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts

Secondary

Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI)

Change in BMI from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

kilogram per square meter (kg/m^2)

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts

Secondary

Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure

Change in systolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

millimeter of mercury (mmHg)

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts

Secondary

Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure

Change in diastolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

mmHg

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts

Secondary

Change in Total Cholesterol-ratio to Baseline

Change in total cholesterol from baseline (week 0) to week 104 measured in milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of total cholesterol

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Secondary

Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline

Change in HDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of HDL cholesterol

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Secondary

Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline

Change in LDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of LDL cholesterol

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Secondary

Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline

Change in VLDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of VLDL cholesterol

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Secondary

Change in Free Fatty Acids-ratio to Baseline

Change in free fatty acids from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of free fatty acids

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units

Secondary

Change in Triglycerides-ratio to Baseline

Change in triglycerides from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of triglycerides

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts

Secondary

Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline

Change in hsCRP from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of hsCRP

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units

Secondary

Change in Glycated Haemoglobin (HbA1c) (Percent [%])

Change in HbA1c from baseline (week 0) to week 104 in % is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

Percent of glycated haemoglobin

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts

Secondary

Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol)

Change in HbA1c from baseline (week 0) to week 104 in millimole per mole (mmol/mol) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

mmol/mol

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts

Secondary

Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L)

Change in FPG from baseline (week 0) to week 104 in millimoles per liter (mmol/L) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

mmol/L

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts

Secondary

Change From Baseline (Week 0) to Week 104 in FPG (mg/dL)

Change in FPG from baseline (week 0) to week 104 in mg/dL is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

mg/dL

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts

Secondary

Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L)

Change in fasting serum insulin from baseline (week 0) to week 104 measured in picomole per liter (pmol) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of fasting serum insulin

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Secondary

Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL)

Change in fasting serum insulin from baseline (week 0) to week 104 measured in milli-international units per milliliter (mIU/mL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of fasting serum insulin

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Secondary

Percentage Change From Baseline (Week 0) to Week 52 in Body Weight

Percentage change in body weight from baseline (week 0) to week 52 is presented.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

percentage change

From Baseline (Week 0) to Week 52

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts
Participants

Secondary

Change From Baseline (Week 0) to Week 52 in Body Weight (kg)

Change in body weight from baseline (week 0) to week 52 in kg is presented.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

kilogram (kg)

From Baseline (Week 0) to Week 52

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts
Participants

Secondary

Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI)

Change in BMI from baseline (week 0) to week 52 is presented.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

kilogram per square meter (kg/m^2)

From Baseline (Week 0) to Week 52

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts
Participants

Secondary

Change From Baseline (Week 0) to Week 52 in Waist Circumference

Change in waist circumference from baseline (week 0) to week 52 is presented.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

centimeter (cm)

From Baseline (Week 0) to Week 52

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts
Participants

Secondary

Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%

Number of participants who achieved >=5% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=5% weight loss, whereas 'No' infers the number of participants who have not achieved >=5% weight loss.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

At Week 52

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts

Secondary

Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%

Number of participants who achieved >=10% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=10% weight loss, whereas 'No' infers the number of participants who have not achieved >=10% weight loss.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

At Week 52

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts

Secondary

Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%

Number of participants who achieved >=15% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=15% weight loss, whereas 'No' infers the number of participants who have not achieved >=15% weight loss.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

At Week 52

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts

Secondary

Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%

Number of participants who achieved >=20% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=20% weight loss, whereas 'No' infers the number of participants who have not achieved >=20% weight loss.

The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Count of Participants

Participants

At Week 52

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Units	Counts

Secondary

Number of Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment. The outcome measure was evaluated based on the data from on-treatment observation period, which 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).

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

Posted

Number

events

From Baseline (Week 0) to Week 111

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Secondary

Number of Serious Adverse Events (SAEs)

A SAE was defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 0 to week 111 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which 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).

The SAS included all randomised participants exposed to at least one dose of randomised treatment.

Posted

Number

events

From Baseline (Week 0) to Week 111

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Secondary

Change From Baseline (Week 0) to Week 104 in Pulse

Change in pulse from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which 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).

The SAS included all randomised participants exposed to at least one dose of randomised treatment. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

beats per minute (beats/min)

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Secondary

Change From Baseline (Week 0) to Week 104 in Amylase

Change in amylase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which 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).

The SAS included all randomised participants exposed to at least one dose of randomised treatment. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Units/liter (U/L)

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Secondary

Change From Baseline (Week 0) to Week 104 in Lipase

Change in lipase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which 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).

The SAS included all randomised participants exposed to at least one dose of randomised treatment. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

U/L

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

Secondary

Change From Baseline (Week 0) to Week 104 in Calcitonin

Change in calcitonin from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which 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).

The SAS included all randomised participants exposed to at least one dose of randomised treatment. Overall Number of Participants Analyzed = participants with available data for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram per liter (ng/L)

From Baseline (Week 0) to Week 104

ID	Title	Description
OG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
OG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.	1	152	12	152	141	152
EG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.	0	152	18	152	117	152

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal adhesions	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Anal abscess	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Appendicitis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Appendicitis perforated	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Arnold-Chiari malformation	Congenital, familial and genetic disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Benign uterine neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
COVID-19	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0012 events2 affected152 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Cervical cord compression	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 23	Systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected152 at risk
Colonic abscess	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Diverticulitis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected152 at risk
Gastritis	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Herpes zoster	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0012 events2 affected152 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Panic disorder	Psychiatric disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Perineal abscess	Infections and infestations	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Pneumonia	Infections and infestations	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected152 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Tension headache	Nervous system disorders	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk
Thyroidectomy	Surgical and medical procedures	MedDRA 23	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected152 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00022 events15 affected152 at risk EG00113 events9 affected152 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00032 events20 affected152 at risk EG00114 events4 affected152 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00023 events22 affected152 at risk EG00113 events10 affected152 at risk
Anxiety	Psychiatric disorders	MedDRA 23	Systematic Assessment	EG0008 events8 affected152 at risk EG00112 events11 affected152 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG00020 events14 affected152 at risk EG00120 events11 affected152 at risk
Asthenia	General disorders	MedDRA 23	Systematic Assessment	EG00010 events8 affected152 at risk EG0013 events2 affected152 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG00017 events15 affected152 at risk EG00120 events19 affected152 at risk
Bronchitis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0009 events8 affected152 at risk EG0019 events8 affected152 at risk
COVID-19	Infections and infestations	MedDRA 23	Systematic Assessment	EG00016 events15 affected152 at risk EG0016 events6 affected152 at risk
Constipation	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00062 events47 affected152 at risk EG00126 events17 affected152 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23	Systematic Assessment	EG0008 events8 affected152 at risk EG00110 events8 affected152 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23	Systematic Assessment	EG00018 events17 affected152 at risk EG0016 events6 affected152 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG000108 events53 affected152 at risk EG00151 events36 affected152 at risk
Dizziness	Nervous system disorders	MedDRA 23	Systematic Assessment	EG00016 events13 affected152 at risk EG00112 events8 affected152 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00024 events20 affected152 at risk EG00112 events7 affected152 at risk
Eructation	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00021 events17 affected152 at risk EG0012 events1 affected152 at risk
Fatigue	General disorders	MedDRA 23	Systematic Assessment	EG00012 events11 affected152 at risk EG0018 events8 affected152 at risk
Flatulence	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00025 events20 affected152 at risk EG00111 events10 affected152 at risk
Gastroenteritis	Infections and infestations	MedDRA 23	Systematic Assessment	EG00028 events20 affected152 at risk EG0014 events4 affected152 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00019 events15 affected152 at risk EG0016 events6 affected152 at risk
Headache	Nervous system disorders	MedDRA 23	Systematic Assessment	EG00036 events16 affected152 at risk EG00131 events16 affected152 at risk
Hypertension	Vascular disorders	MedDRA 23	Systematic Assessment	EG0006 events6 affected152 at risk EG00114 events14 affected152 at risk
Influenza	Infections and infestations	MedDRA 23	Systematic Assessment	EG00023 events20 affected152 at risk EG00119 events16 affected152 at risk
Injection site bruising	General disorders	MedDRA 23	Systematic Assessment	EG0008 events5 affected152 at risk EG00111 events8 affected152 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 23	Systematic Assessment	EG00010 events10 affected152 at risk EG0011 events1 affected152 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23	Systematic Assessment	EG00033 events24 affected152 at risk EG00131 events23 affected152 at risk
Nausea	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG000213 events81 affected152 at risk EG00153 events33 affected152 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23	Systematic Assessment	EG00010 events9 affected152 at risk EG0019 events8 affected152 at risk
Sinusitis	Infections and infestations	MedDRA 23	Systematic Assessment	EG0008 events8 affected152 at risk EG0019 events9 affected152 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23	Systematic Assessment	EG00031 events20 affected152 at risk EG00130 events23 affected152 at risk
Urinary tract infection	Infections and infestations	MedDRA 23	Systematic Assessment	EG00019 events12 affected152 at risk EG0017 events6 affected152 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23	Systematic Assessment	EG00078 events46 affected152 at risk EG0018 events7 affected152 at risk

ID	Term
D050177	Overweight
D009765	Obesity

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Semaglutide 2.4 mg	Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.
BG001	Placebo	Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.
BG002	Total	Total of all reporting groups