A Phase 3 interventional study of Semaglutide 1.0 mg and Semaglutide 2.4 mg in Obesity and Overweight, sponsored by Novo Nordisk A/S. Completed at 147 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-09.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This study will look at the change in the participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time 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 1.5 years
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 1,210 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
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Exclusion Criteria:
Participants will receive semaglutide 1.0 mg and semaglutide placebo I during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.
Drug: Semaglutide 1.0 mg · Drug: Placebo I (Semaglutide)
Participants will receive semaglutide 2.4 mg and semaglutide placebo II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.
Drug: Semaglutide 2.4 mg · Drug: Placebo II (Semaglutide)
Participants will receive semaglutide placebo I and II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.
Drug: Placebo I (Semaglutide) · Drug: Placebo II (Semaglutide)
Subcutaneous (s.c.) injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.
Subcutaneous injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.
Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo
Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Time frame: Baseline (week 0) to week 68
Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo
Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Time frame: At week 68
Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg
Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg
Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: At week 68
Change in Waist Circumference
Change in waist circumference from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in Body Weight (Kg)
Change in body weight (kg) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in BMI
Change in body mass index (BMI) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Participants Who Achieve (Yes/no): Body Weight Reduction ≥10%
Number of participants who achieved weight reduction ≥10% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: At week 68
Participants Who Achieve (Yes/no): Body Weight Reduction ≥15%
Number of participants who achieved weight reduction ≥15% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: At week 68
Participants Who Achieve (Yes/no): Body Weight Reduction ≥20%
Number of participants who achieved weight reduction ≥20% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: At week 68
Change in HbA1c (%)
Change in glycated haemoglobin (HbA1c (%)) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in HbA1c (mmol/Mol)
Change in HbA1c (mmol/mol) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in FPG (mg/dL)
Change in fasting plasma glucose (FPG) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in Fasting Serum Insulin
Change in fasting serum insulin from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol)
Number of participants who achieved HbA1c \<7% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: At week 68
Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)
Number of participants who achieved HbA1c ≤6.5% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: At week 68
Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0%
Number of participants who achieved weight reduction ≥10% of their baseline body weight and HbA1c \<7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: At week 68
Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0%
Number of participants who achieved weight reduction ≥15% of their baseline body weight and HbA1c \<7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: At week 68
Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in Diastolic Blood Pressure
Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in Total Cholesterol
Change in total cholesterol (measured in milligram per decilitre (mg/dL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in HDL Cholesterol
Change in high density lipoprotein (HDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in LDL Cholesterol
Change in low density lipoprotein (LDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in VLDL Cholesterol
Change in very low density lipoprotein (VLDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in Free Fatty Acids
Change in free fatty acids (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in Triglycerides
Change in triglycerides (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in hsCRP
Change in high sensitivity C-reactive protein (hsCRP; measured in milligram per ilitre (mg/L)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in PAI-1 Activity
Change in Plasminogen Activator Inhibitor-1 (PAI-1; measured in arbritary units per millilitre (AU/mL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score)
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for 'physical functioning domain'. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.
Time frame: Baseline (week 0) to week 68
Change in SF-36 (All Scores Except Physical Functioning)
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains, except physical functioning. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.
Time frame: Baseline (week 0) to week 68
Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score)
The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function domain'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Change in IWQOL-Lite for CT (All Scores Except Physical Function)
The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical and psychosocial domains, and for total'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
Time frame: Baseline (week 0) to week 68
Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score
The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. Endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
Time frame: At week 68
Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score
The observed number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on two different thresholds. The threshold of 20 was a preliminary responder threshold based on earlier studies. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which was defined as the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
Time frame: At week 68
Number of TEAEs - Semaglutide 2.4 mg Versus Placebo
Adverse events (AEs) with onset during the on-treatment observation period were defined as treatment-emergent AEs (TEAEs). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.
Time frame: Week 0 to week 75
Number of SAEs - Semaglutide 2.4 mg Versus Placebo
Serious adverse event (SAE) results are based on the on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.
Time frame: Week 0 to week 75
Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo
Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least 7 consecutive missed doses. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. Blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Week 0 to week 75
Change in Pulse - Semaglutide 2.4 mg Versus Placebo
Change in pulse from baseline (week 0) to week 68 is presented. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Time frame: Baseline (week 0) to week 68
Change in Amylase - Semaglutide 2.4 mg Versus Placebo
Change in amylase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Time frame: Baseline (week 0) to week 68
Change in Lipase - Semaglutide 2.4 mg Versus Placebo
Change in lipase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Time frame: Baseline (week 0) to week 68
Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo
Change in calcitonin (nanogram/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Time frame: Baseline (week 0) to week 68
The trial was conducted at 149 sites in 12 countries as follows: Argentina (5 sites), Canada (10 sites), Germany (9 sites), Greece (6 sites), India (18 sites), Japan (12 sites), Russian Federation (9 sites), South Africa (6 sites), Spain (8 sites), United Arab Emirates (5 sites), United Kingdom (10 sites) and United States (51 sites).
| Milestone | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Started | 403 | 404 | 403 |
| Exposed | 402 | 403 | 402 |
| Full analysis set (fas) | 403 | 404 | 403 |
| Safety analysis set (sas) | 402 | 403 | 402 |
| Completed | 390 | 391 | 383 |
| Not completed | 13 | 13 | 20 |
| Withdrew: Withdrawal by subject | 10 | 5 | 12 |
| Withdrew: Lost to follow-up | 2 | 7 | 7 |
| Withdrew: Death | 1 | 1 | 1 |
Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
| Percentage point of body weight | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| In-trial observation period | -9.9 ± 8.0 | -3.3 ± 5.5 |
| On-treatment observation period | -10.7 ± 7.8 | -3.1 ± 5.2 |
Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
| Participants | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| In-trial observation period — Yes | 267 | 107 |
| In-trial observation period — No | 121 | 269 |
| On-treatment observation period — Yes | 257 | 94 |
| On-treatment observation period — No | 94 | 246 |
Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Percentage point of body weight | Semaglutide 2.4 mg | Semaglutide 1.0 mg |
|---|---|---|
| Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg | -9.9 ± 8.0 | -7.2 ± 6.6 |
Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Participants | Semaglutide 2.4 mg | Semaglutide 1.0 mg |
|---|---|---|
| Yes | 267 | 217 |
| No | 121 | 163 |
Change in waist circumference from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Centimetre (cm) | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in Waist Circumference | -6.9 ± 6.8 | -9.7 ± 8.1 | -4.3 ± 6.5 |
Change in body weight (kg) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Kilogram (kg) | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in Body Weight (Kg) | -7.1 ± 6.7 | -9.9 ± 8.5 | -3.4 ± 6.2 |
Change in body mass index (BMI) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| kilogram per square meter (kg/m^2) | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in BMI | -2.6 ± 2.4 | -3.6 ± 3.1 | -1.2 ± 2.1 |
Number of participants who achieved weight reduction ≥10% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Participants | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Yes | 109 | 177 | 31 |
| No | 271 | 211 | 345 |
Number of participants who achieved weight reduction ≥15% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Participants | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Yes | 52 | 100 | 12 |
| No | 328 | 288 | 364 |
Number of participants who achieved weight reduction ≥20% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Participants | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Yes | 18 | 51 | 6 |
| No | 362 | 337 | 370 |
Change in glycated haemoglobin (HbA1c (%)) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Percentage point of HbA1c | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in HbA1c (%) | -1.5 ± 1.1 | -1.7 ± 1.2 | -0.3 ± 1.3 |
Change in HbA1c (mmol/mol) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| millimoles per mole (mmol/mol) | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in HbA1c (mmol/Mol) | -16.9 ± 12.3 | -18.7 ± 13.0 | -3.4 ± 14.3 |
Change in fasting plasma glucose (FPG) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| milligrams per deciliter (mg/dL) | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in FPG (mg/dL) | -36.5 ± 45.1 | -37.9 ± 45.9 | -2.3 ± 53.1 |
Change in fasting serum insulin from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Picomoles per litre (pmol/L) | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in Fasting Serum Insulin | 0.94 ± 59.8 | 0.90 ± 65.4 | 0.93 ± 53.6 |
Number of participants who achieved HbA1c \<7% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Participants | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Yes | 272 | 299 | 99 |
| No | 104 | 82 | 275 |
Number of participants who achieved HbA1c ≤6.5% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Participants | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Yes | 226 | 257 | 58 |
| No | 150 | 124 | 316 |
Number of participants who achieved weight reduction ≥10% of their baseline body weight and HbA1c \<7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Participants | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Yes | 105 | 170 | 25 |
| No | 271 | 211 | 349 |
Number of participants who achieved weight reduction ≥15% of their baseline body weight and HbA1c \<7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Participants | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Yes | 49 | 98 | 11 |
| No | 327 | 283 | 363 |
Change in systolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Millimetre of mercury (mmHg) | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in Systolic Blood Pressure | -3 ± 15 | -4 ± 14 | 0 ± 15 |
Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Millimetre of mercury (mmHg) | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in Diastolic Blood Pressure | -1 ± 9 | -2 ± 9 | -1 ± 9 |
Change in total cholesterol (measured in milligram per decilitre (mg/dL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Ratio of total cholesterol | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in Total Cholesterol | 0.97 ± 20.1 | 0.99 ± 17.9 | 1.00 ± 18.9 |
Change in high density lipoprotein (HDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Ratio of HDL cholesterol | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in HDL Cholesterol | 1.06 ± 16.0 | 1.07 ± 15.7 | 1.04 ± 15.3 |
Change in low density lipoprotein (LDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Ratio of LDL cholesterol | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in LDL Cholesterol | 0.99 ± 37.5 | 1.00 ± 30.9 | 1.00 ± 28.9 |
Change in very low density lipoprotein (VLDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Ratio of VLDL cholesterol | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in VLDL Cholesterol | 0.82 ± 42.1 | 0.80 ± 42.0 | 0.92 ± 40.5 |
Change in free fatty acids (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Ratio of free fatty acids | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in Free Fatty Acids | 0.85 ± 61.4 | 0.84 ± 68.7 | 1.01 ± 62.3 |
Change in triglycerides (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Ratio of triglycerides | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in Triglycerides | 0.81 ± 44.5 | 0.79 ± 43.8 | 0.92 ± 44.5 |
Change in high sensitivity C-reactive protein (hsCRP; measured in milligram per ilitre (mg/L)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Ratio of hsCRP | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in hsCRP | 0.59 ± 115.7 | 0.50 ± 125.7 | 0.84 ± 90.9 |
Change in Plasminogen Activator Inhibitor-1 (PAI-1; measured in arbritary units per millilitre (AU/mL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Ratio of PAI-1 activity | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in PAI-1 Activity | 1.21 ± 73.7 | 1.06 ± 80.8 | 1.42 ± 68.9 |
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for 'physical functioning domain'. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.
| Score on a scale | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score) | 2.1 ± 6.8 | 2.8 ± 7.7 | 0.8 ± 7.0 |
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains, except physical functioning. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.
| Score on a scale | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Role-Physical | 0.6 ± 6.9 | 0.8 ± 7.4 | 0.0 ± 7.1 |
| Bodily Pain | 0.4 ± 8.3 | 0.3 ± 9.0 | -0.4 ± 8.6 |
| General Health | 1.7 ± 7.2 | 2.2 ± 7.3 | 0.6 ± 7.5 |
| Vitality | -0.1 ± 7.8 | 0.8 ± 7.9 | -0.9 ± 7.9 |
| Social Functioning | -0.3 ± 6.6 | 0.2 ± 6.6 | -0.7 ± 7.4 |
| Role-Emotional | -0.4 ± 7.3 | -0.4 ± 7.7 | -1.1 ± 7.8 |
| Mental Health | -0.9 ± 7.5 | -0.4 ± 6.9 | -1.6 ± 7.5 |
| Physical component summary | 1.9 ± 6.4 | 2.3 ± 7.2 | 0.9 ± 6.6 |
| Mental component summary | -1.4 ± 7.4 | -0.9 ± 6.9 | -1.8 ± 7.6 |
The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function domain'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Score on a scale | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score) | 8.5 ± 18.8 | 11.4 ± 20.8 | 4.9 ± 20.4 |
The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical and psychosocial domains, and for total'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.
| Score on a scale | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Physical | 7.6 ± 18.0 | 11.0 ± 19.6 | 4.4 ± 19.1 |
| Psychosocial | 8.6 ± 15.7 | 9.6 ± 16.7 | 5.6 ± 16.5 |
| Total | 8.2 ± 14.8 | 10.1 ± 15.9 | 5.2 ± 15.5 |
The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. Endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
| Participants | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Yes (with threshold 4.3) | 88 | 111 | 68 |
| No (with threshold 4.3) | 282 | 265 | 297 |
| Yes (with threshold 3.7) | 130 | 158 | 102 |
| No (with threshold 3.7) | 240 | 218 | 263 |
The observed number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on two different thresholds. The threshold of 20 was a preliminary responder threshold based on earlier studies. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which was defined as the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
| Participants | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Yes (with threshold 20) | 107 | 131 | 83 |
| No (with threshold 20) | 262 | 245 | 282 |
| Yes (with threshold 14.6) | 144 | 160 | 113 |
| No (with threshold 14.6) | 225 | 216 | 252 |
Adverse events (AEs) with onset during the on-treatment observation period were defined as treatment-emergent AEs (TEAEs). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.
| Events | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Number of TEAEs - Semaglutide 2.4 mg Versus Placebo | 2197 | 1388 |
Serious adverse event (SAE) results are based on the on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.
| Events | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Number of SAEs - Semaglutide 2.4 mg Versus Placebo | 71 | 53 |
Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least 7 consecutive missed doses. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. Blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that is BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
| Episodes | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo | 51 | 18 |
Change in pulse from baseline (week 0) to week 68 is presented. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
| Beats/minute | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Pulse - Semaglutide 2.4 mg Versus Placebo | 2 ± 9 | 0 ± 9 |
Change in amylase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
| Ratio of amylase | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Amylase - Semaglutide 2.4 mg Versus Placebo | 1.24 ± 28.3 | 1.06 ± 25.0 |
Change in lipase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
| Ratio of lipase | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Lipase - Semaglutide 2.4 mg Versus Placebo | 1.41 ± 57.2 | 0.99 ± 51.8 |
Change in calcitonin (nanogram/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
| Ratio of calcitonin | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo | 0.94 ± 60.3 | 0.96 ± 38.6 |
Collected over Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Semaglutide 1.0 mg | 1/402 (0.2%) | 31/402 (7.7%) | 261/402 (64.9%) |
| Semaglutide 2.4 mg | 1/403 (0.2%) | 40/403 (9.9%) | 284/403 (70.5%) |
| Placebo | 1/402 (0.2%) | 37/402 (9.2%) | 190/402 (47.3%) |
| Event | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Abdominal painGastrointestinal disorders | 3/402 | 0/403 | 0/402 |
| GastroenteritisInfections and infestations | 3/402 | 3/403 | 1/402 |
| SepsisInfections and infestations | 3/402 | 0/403 | 0/402 |
| Acute kidney injuryRenal and urinary disorders | 2/402 | 2/403 | 1/402 |
| Acute myocardial infarctionCardiac disorders | 2/402 | 1/403 | 1/402 |
| Atrial fibrillationCardiac disorders | 2/402 | 2/403 | 2/402 |
| CellulitisInfections and infestations | 2/402 | 0/403 | 1/402 |
| DehydrationMetabolism and nutrition disorders | 2/402 | 1/403 | 1/402 |
| NauseaGastrointestinal disorders | 2/402 | 1/403 | 0/402 |
| PneumoniaInfections and infestations | 1/402 | 1/403 | 2/402 |
| Event | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| NauseaGastrointestinal disorders | 128/402 | 135/403 | 37/402 |
| DiarrhoeaGastrointestinal disorders | 88/402 | 86/403 | 48/402 |
| VomitingGastrointestinal disorders | 54/402 | 86/403 | 11/402 |
| ConstipationGastrointestinal disorders | 51/402 | 70/403 | 22/402 |
| NasopharyngitisInfections and infestations | 47/402 | 68/403 | 59/402 |
| Upper respiratory tract infectionInfections and infestations | 37/402 | 42/403 | 38/402 |
| Decreased appetiteMetabolism and nutrition disorders | 29/402 | 38/403 | 15/402 |
| HeadacheNervous system disorders | 33/402 | 31/403 | 20/402 |
| Back painMusculoskeletal and connective tissue disorders | 28/402 | 27/403 | 14/402 |
| FatigueGeneral disorders | 19/402 | 28/403 | 4/402 |
Full analysis set (FAS) which comprised all randomised participants.
| Age, Continuous(Year) | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 56 ± 10 | 55 ± 11 | 55 ± 11 | 55 ± 11 |
| Sex: Female, Male(Participants) | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 203 | 223 | 190 | 616 |
| Male | 200 | 181 | 213 | 594 |
| Race/Ethnicity, Customized(Participants) | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo | Total |
|---|---|---|---|---|
| White | 272 | 237 | 242 | 751 |
| Asian | 97 | 112 | 108 | 317 |
| Black or African American | 28 | 35 | 37 | 100 |
| Other | 6 | 16 | 13 | 35 |
| American Indian or Alaska Native | 0 | 4 | 2 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 |
| Not Applicable | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo | Total |
|---|---|---|---|---|
| Not Hispanic or Latino | 344 | 357 | 354 | 1055 |
| Hispanic or Latino | 59 | 47 | 49 | 155 |
| Not Applicable | 0 | 0 | 0 | 0 |
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