Obesity, Overweight
Conditions
Brief summary
This study will look at the change in body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking dummy medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or dummy medicine - which treatment the participant gets is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor.
Interventions
DRUGSemaglutide
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
DRUGPlacebo (Semaglutide)
S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 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
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male or female, age more than or equal to 18 years at the time of signing informed consent * Body mass index (BMI) more than or equal to 30 kg/m\^2 or more than or equal to 27 kg/m\^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease * History of at least one self-reported unsuccessful dietary effort to lose body weight
Exclusion criteria
* HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening * A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline (Week 0) to Week 104 in Body Weight | From Baseline (Week 0) to Week 104 | 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). |
| Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% | At Week 104 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% | At Week 104 | 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. |
| Change From Baseline (Week 0) to Week 104 in Waist Circumference | From Baseline (Week 0) to Week 104 | 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. |
| Change From Baseline (Week 0) to Week 104 in Body Weight (kg) | From Baseline (Week 0) to Week 104 | 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. |
| Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI) | From Baseline (Week 0) to Week 104 | 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. |
| Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure | From Baseline (Week 0) to Week 104 | 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. |
| Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure | From Baseline (Week 0) to Week 104 | 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. |
| Change in Total Cholesterol-ratio to Baseline | From Baseline (Week 0) to Week 104 | 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. |
| Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline | From Baseline (Week 0) to Week 104 | 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. |
| Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline | From Baseline (Week 0) to Week 104 | 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. |
| Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline | From Baseline (Week 0) to Week 104 | 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. |
| Change in Free Fatty Acids-ratio to Baseline | From Baseline (Week 0) to Week 104 | 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. |
| Change in Triglycerides-ratio to Baseline | From Baseline (Week 0) to Week 104 | 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. |
| Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline | From Baseline (Week 0) to Week 104 | 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. |
| Change in Glycated Haemoglobin (HbA1c) (Percent [%]) | From Baseline (Week 0) to Week 104 | 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. |
| Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol) | From Baseline (Week 0) to Week 104 | 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. |
| Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L) | From Baseline (Week 0) to Week 104 | 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. |
| Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% | At Week 104 | 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. |
| Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L) | From Baseline (Week 0) to Week 104 | 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. |
| Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL) | From Baseline (Week 0) to Week 104 | 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. |
| Percentage Change From Baseline (Week 0) to Week 52 in Body Weight | From Baseline (Week 0) to Week 52 | Percentage change in body weight from baseline (week 0) to week 52 is presented. |
| Change From Baseline (Week 0) to Week 52 in Body Weight (kg) | From Baseline (Week 0) to Week 52 | Change in body weight from baseline (week 0) to week 52 in kg is presented. |
| Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI) | From Baseline (Week 0) to Week 52 | Change in BMI from baseline (week 0) to week 52 is presented. |
| Change From Baseline (Week 0) to Week 52 in Waist Circumference | From Baseline (Week 0) to Week 52 | Change in waist circumference from baseline (week 0) to week 52 is presented. |
| Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% | At Week 52 | 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. |
| Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% | At Week 52 | 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. |
| Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% | At Week 52 | 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. |
| Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% | At Week 52 | 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. |
| Number of Treatment-emergent Adverse Events (TEAEs) | From Baseline (Week 0) to Week 111 | 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). |
| Number of Serious Adverse Events (SAEs) | From Baseline (Week 0) to Week 111 | 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). |
| Change From Baseline (Week 0) to Week 104 in Pulse | From Baseline (Week 0) to Week 104 | 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). |
| Change From Baseline (Week 0) to Week 104 in Amylase | From Baseline (Week 0) to Week 104 | 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). |
| Change From Baseline (Week 0) to Week 104 in Lipase | From Baseline (Week 0) to Week 104 | 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). |
| Change From Baseline (Week 0) to Week 104 in Calcitonin | From Baseline (Week 0) to Week 104 | 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). |
| Change From Baseline (Week 0) to Week 104 in FPG (mg/dL) | From Baseline (Week 0) to Week 104 | 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. |
| Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% | At Week 104 | 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. |
Countries
Canada, Hungary, Italy, Spain, United States
Participant flow
Recruitment details
The trial was conducted at 41 sites in 5 countries as follows: Canada (9 sites), Hungary (6 sites), Italy (5 sites), Spain (6 sites), and United States (15 sites).
Pre-assignment details
Participants were randomized in a 1:1 manner to receive treatment with semaglutide 2.4 milligram (mg) or placebo once weekly as an adjunct to a reduced-calorie diet and increased physical activity. The trial has a 104 weeks treatment period (16 weeks of dose escalation period and 88 weeks of maintenance dose).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 152 |
| Placebo Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks. | 152 |
| Total | 304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 14 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Semaglutide 2.4 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 12 | 47 years STANDARD_DEVIATION 10 | 47 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 21 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 134 Participants | 131 Participants | 265 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 141 Participants | 142 Participants | 283 Participants |
| Sex: Female, Male Female | 123 Participants | 113 Participants | 236 Participants |
| Sex: Female, Male Male | 29 Participants | 39 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 152 | 0 / 152 |
| other Total, other adverse events | 141 / 152 | 117 / 152 |
| serious Total, serious adverse events | 12 / 152 | 18 / 152 |
Outcome results
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).
Time frame: At Week 104
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% | In-trial observation period | Yes | 111 Participants |
| Semaglutide 2.4 mg | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% | In-trial observation period | No | 33 Participants |
| Semaglutide 2.4 mg | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% | On-treatment observation period | Yes | 110 Participants |
| Semaglutide 2.4 mg | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% | On-treatment observation period | No | 22 Participants |
| Placebo | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% | On-treatment observation period | No | 71 Participants |
| Placebo | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% | In-trial observation period | Yes | 44 Participants |
| Placebo | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% | On-treatment observation period | Yes | 38 Participants |
| Placebo | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% | In-trial observation period | No | 84 Participants |
Comparison: Treatment policy estimandp-value: <0.000195% CI: [2.95, 8.42]Regression, Logistic
Comparison: Hypothetical estimandp-value: <0.000195% CI: [10.04, 32.49]MMRM
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).
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 2.4 mg | Percentage Change From Baseline (Week 0) to Week 104 in Body Weight | In-trial observation period | -15.9 percentage change | Standard Deviation 12.3 |
| Semaglutide 2.4 mg | Percentage Change From Baseline (Week 0) to Week 104 in Body Weight | On-treatment observation period | -17.3 percentage change | Standard Deviation 11.9 |
| Placebo | Percentage Change From Baseline (Week 0) to Week 104 in Body Weight | In-trial observation period | -1.9 percentage change | Standard Deviation 8.9 |
| Placebo | Percentage Change From Baseline (Week 0) to Week 104 in Body Weight | On-treatment observation period | -2.0 percentage change | Standard Deviation 8.6 |
Comparison: Treatment policy estimandp-value: <0.000195% CI: [-15.33, -9.77]ANCOVA
Comparison: Hypothetical estimandp-value: <0.000195% CI: [-18.64, -13.45]MMRM (Mixed model repeated measurement)
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).
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 104 in Amylase | 1.13 Units/liter (U/L) | Geometric Coefficient of Variation 20.7 |
| Placebo | Change From Baseline (Week 0) to Week 104 in Amylase | 1.02 Units/liter (U/L) | Geometric Coefficient of Variation 15.1 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI) | -6.2 kilogram per square meter (kg/m^2) | Standard Deviation 5.3 |
| Placebo | Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI) | -0.7 kilogram per square meter (kg/m^2) | Standard Deviation 3.5 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 104 in Body Weight (kg) | -16.9 kilogram | Standard Deviation 14 |
| Placebo | Change From Baseline (Week 0) to Week 104 in Body Weight (kg) | -2.1 kilogram | Standard Deviation 9.5 |
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).
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 104 in Calcitonin | 0.99 nanogram per liter (ng/L) | Geometric Coefficient of Variation 21.5 |
| Placebo | Change From Baseline (Week 0) to Week 104 in Calcitonin | 0.97 nanogram per liter (ng/L) | Geometric Coefficient of Variation 41 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure | -4 mmHg | Standard Deviation 10 |
| Placebo | Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure | -1 mmHg | Standard Deviation 9 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L) | -0.5 mmol/L | Standard Deviation 0.5 |
| Placebo | Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L) | 0.1 mmol/L | Standard Deviation 0.6 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 104 in FPG (mg/dL) | -8.3 mg/dL | Standard Deviation 9.6 |
| Placebo | Change From Baseline (Week 0) to Week 104 in FPG (mg/dL) | 1.8 mg/dL | Standard Deviation 10.8 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol) | -5.1 mmol/mol | Standard Deviation 3.2 |
| Placebo | Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol) | -1.0 mmol/mol | Standard Deviation 3 |
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).
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 104 in Lipase | 1.47 U/L | Geometric Coefficient of Variation 52.3 |
| Placebo | Change From Baseline (Week 0) to Week 104 in Lipase | 1.00 U/L | Geometric Coefficient of Variation 34.4 |
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).
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 104 in Pulse | 3 beats per minute (beats/min) | Standard Deviation 10 |
| Placebo | Change From Baseline (Week 0) to Week 104 in Pulse | -1 beats per minute (beats/min) | Standard Deviation 9 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure | -6 millimeter of mercury (mmHg) | Standard Deviation 13 |
| Placebo | Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure | -1 millimeter of mercury (mmHg) | Standard Deviation 15 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 104 in Waist Circumference | -15.2 centimeter (cm) | Standard Deviation 12.4 |
| Placebo | Change From Baseline (Week 0) to Week 104 in Waist Circumference | -4.3 centimeter (cm) | Standard Deviation 9.1 |
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.
Time frame: From Baseline (Week 0) to Week 52
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI) | -6.1 kilogram per square meter (kg/m^2) | Standard Deviation 3.8 |
| Placebo | Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI) | -1.3 kilogram per square meter (kg/m^2) | Standard Deviation 2.6 |
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.
Time frame: From Baseline (Week 0) to Week 52
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 52 in Body Weight (kg) | -16.7 kilogram (kg) | Standard Deviation 10.3 |
| Placebo | Change From Baseline (Week 0) to Week 52 in Body Weight (kg) | -3.5 kilogram (kg) | Standard Deviation 7.4 |
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.
Time frame: From Baseline (Week 0) to Week 52
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change From Baseline (Week 0) to Week 52 in Waist Circumference | -14.3 centimeter (cm) | Standard Deviation 9.4 |
| Placebo | Change From Baseline (Week 0) to Week 52 in Waist Circumference | -4.5 centimeter (cm) | Standard Deviation 6.8 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL) | 0.68 Ratio of fasting serum insulin | Geometric Coefficient of Variation 54.1 |
| Placebo | Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL) | 0.96 Ratio of fasting serum insulin | Geometric Coefficient of Variation 62.9 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L) | 0.68 Ratio of fasting serum insulin | Geometric Coefficient of Variation 54.1 |
| Placebo | Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L) | 0.96 Ratio of fasting serum insulin | Geometric Coefficient of Variation 62.9 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Free Fatty Acids-ratio to Baseline | 0.99 Ratio of free fatty acids | Geometric Coefficient of Variation 71.2 |
| Placebo | Change in Free Fatty Acids-ratio to Baseline | 1.07 Ratio of free fatty acids | Geometric Coefficient of Variation 69.1 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Glycated Haemoglobin (HbA1c) (Percent [%]) | -0.5 Percent of glycated haemoglobin | Standard Deviation 0.3 |
| Placebo | Change in Glycated Haemoglobin (HbA1c) (Percent [%]) | -0.1 Percent of glycated haemoglobin | Standard Deviation 0.3 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline | 1.09 Ratio of HDL cholesterol | Geometric Coefficient of Variation 19.1 |
| Placebo | Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline | 1.08 Ratio of HDL cholesterol | Geometric Coefficient of Variation 15.4 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline | 0.41 Ratio of hsCRP | Geometric Coefficient of Variation 149.1 |
| Placebo | Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline | 0.99 Ratio of hsCRP | Geometric Coefficient of Variation 105.5 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline | 0.93 Ratio of LDL cholesterol | Geometric Coefficient of Variation 23.8 |
| Placebo | Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline | 0.99 Ratio of LDL cholesterol | Geometric Coefficient of Variation 19.1 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Total Cholesterol-ratio to Baseline | 0.96 Ratio of total cholesterol | Geometric Coefficient of Variation 15.3 |
| Placebo | Change in Total Cholesterol-ratio to Baseline | 1.02 Ratio of total cholesterol | Geometric Coefficient of Variation 13.5 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Triglycerides-ratio to Baseline | 0.79 Ratio of triglycerides | Geometric Coefficient of Variation 42.4 |
| Placebo | Change in Triglycerides-ratio to Baseline | 1.03 Ratio of triglycerides | Geometric Coefficient of Variation 36 |
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.
Time frame: From Baseline (Week 0) to Week 104
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline | 0.79 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 42.3 |
| Placebo | Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline | 1.03 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 35.1 |
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.
Time frame: At Week 104
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% | Yes | 89 Participants |
| Semaglutide 2.4 mg | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% | No | 55 Participants |
| Placebo | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% | Yes | 17 Participants |
| Placebo | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% | No | 111 Participants |
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.
Time frame: At Week 104
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% | Yes | 75 Participants |
| Semaglutide 2.4 mg | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% | No | 69 Participants |
| Placebo | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% | Yes | 9 Participants |
| Placebo | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% | No | 119 Participants |
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.
Time frame: At Week 104
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% | Yes | 52 Participants |
| Semaglutide 2.4 mg | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% | No | 92 Participants |
| Placebo | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% | Yes | 3 Participants |
| Placebo | Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% | No | 125 Participants |
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.
Time frame: At Week 52
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% | Yes | 102 Participants |
| Semaglutide 2.4 mg | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% | No | 47 Participants |
| Placebo | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% | Yes | 17 Participants |
| Placebo | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% | No | 112 Participants |
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.
Time frame: At Week 52
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% | Yes | 78 Participants |
| Semaglutide 2.4 mg | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% | No | 71 Participants |
| Placebo | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% | Yes | 7 Participants |
| Placebo | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% | No | 122 Participants |
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.
Time frame: At Week 52
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% | Yes | 52 Participants |
| Semaglutide 2.4 mg | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% | No | 97 Participants |
| Placebo | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% | Yes | 3 Participants |
| Placebo | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% | No | 126 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.
Time frame: At Week 52
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% | Yes | 132 Participants |
| Semaglutide 2.4 mg | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% | No | 17 Participants |
| Placebo | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% | Yes | 38 Participants |
| Placebo | Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% | No | 91 Participants |
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).
Time frame: From Baseline (Week 0) to Week 111
Population: The SAS included all randomised participants exposed to at least one dose of randomised treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 2.4 mg | Number of Serious Adverse Events (SAEs) | 18 events |
| Placebo | Number of Serious Adverse Events (SAEs) | 20 events |
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).
Time frame: From Baseline (Week 0) to Week 111
Population: The safety analysis set (SAS) included all randomised participants exposed to at least one dose of randomised treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 2.4 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 1645 events |
| Placebo | Number of Treatment-emergent Adverse Events (TEAEs) | 1059 events |
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.
Time frame: From Baseline (Week 0) to Week 52
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Percentage Change From Baseline (Week 0) to Week 52 in Body Weight | -15.8 percentage change | Standard Deviation 9.3 |
| Placebo | Percentage Change From Baseline (Week 0) to Week 52 in Body Weight | -3.3 percentage change | Standard Deviation 6.4 |