Metabolism and Nutrition Disorder, Overweight or Obesity
Conditions
Brief summary
This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking dummy medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. Participants will either get semaglutide or dummy medicine - which treatment participants get, 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 has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.
Interventions
DRUGSemaglutide
Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks. Dose escalation of semaglutide will take place as follows: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 68.
DRUGPlacebo (semaglutide)
Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main phase: * Male or female, age greater than or equal to 18 years at the time of signing informed consent * Body mass index (BMI) greater than or equal to 30.0 kg/sqm or greater than or equal to 27.0 kg/sqm 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 Extension phase: * Informed consent for the extension phase obtained before any trial related activities for the extension phase * On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo
Exclusion criteria
Main phase: * Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening * A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records Extension phase: * Female who is pregnant or intends to become pregnant during the extension phase * Any disorder, unwillingness or inability, not covered by any of the other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (%) | Baseline (week 0) to week 68 | Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period). |
| Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | After week 68 | Number of participants who achieved weight loss more than or equal to 5% (yes/no) at week 68 are presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no) | Week 68 | Number of participants who achieved more than or equal to (≥) 20% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Waist Circumference (cm) | Baseline (week 0) to week 68 | Change in waist circumference from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75). |
| Change in Systolic Blood Pressure (mmHg) | Baseline (week 0) to week 68 | Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75). |
| Change in Short Form 36 (SF-36) | Baseline (week 0) to week 68 | 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 eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation, respectively, for the 2009 US general population. 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. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score | Baseline (week 0) to week 68 | IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. It is used to assess the impact of body weight changes on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Body Weight (kg) | Baseline (week 0) to week 68 | Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Body Mass Index (BMI) (kg/m2) | Baseline (week 0) to week 68 | Change in body mass index from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in HbA1C (%) | Baseline (week 0) to week 68 | Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in HbA1C (mmol/Mol) | Baseline (week 0) to week 68 | Change in HbA1c from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Fasting Plasma Glucose (FPG) (mg/dL) | Baseline (week 0) to week 68 | Change in fasting plasma glucose from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline | Baseline (week 0) to week 68 | Change in fasting serum insulin from week 0 to week 68 is presented as ratio to baseline. Fasting serum insulin was measured in milli-international units per milliliter (mIU/mL). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Diastolic Blood Pressure (mmHg) | Baseline (week 0) to week 68 | Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Total Cholesterol (mg/dL) - Ratio to Baseline | Baseline (week 0) to week 68 | Change in fasting total cholesterol from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline | Baseline (week 0) to week 68 | Change in fasting HDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline | Baseline (week 0) to week 68 | Change in fasting LDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline | Baseline (week 0) to week 68 | Change in fasting VLDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Free Fatty Acids (mg/dL) - Ratio to Baseline | Baseline (week 0) to week 68 | Change in fasting free fatty acids from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Triglycerides (mg/dL) - Ratio to Baseline | Baseline (week 0) to week 68 | Change in fasting triglycerides from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline | Baseline (week 0) to week 68 | Change in high sensitivity C-reactive protein from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline | Baseline (week 0) to week 68 | Change in plasminogen activator inhibitor-1 activity from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline | Baseline (week 0) to week 68 | Change in soluble leptin receptor from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Leptin (ng/mL) - Ratio to Baseline | Baseline (week 0) to week 68 | Change in leptin from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Body Composition (Total Fat Mass) (%) | Baseline (week 0) to week 68 | Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Body Composition (Total Fat Mass) (kg) | Baseline (week 0) to week 68 | Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Body Composition (Lean Body Mass) (%) | Baseline (week 0) to week 68 | Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Body Composition (Lean Body Mass) (kg) | Baseline (week 0) to week 68 | Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Body Composition (Visceral Fat Mass) (%) | Baseline (week 0) to week 68 | Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Body Composition (Visceral Fat Mass) (kg) | Baseline (week 0) to week 68 | Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Body Weight (%) - DEXA Subpopulation | Baseline (week 0) to week 68 | Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Change in Body Weight (kg) - DEXA Subpopulation | Baseline (week 0) to week 68 | Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
| Participants Who Achieve Responder Definition Value (Yes/no) for SF-36 Physical Functioning Score | After week 68 | The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two different 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 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 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 is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75). |
| Participants Who Achieve Responder Definition Value (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score | After week 68 | 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. In trial observation period: the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75). |
| Number of Treatment Emergent Adverse Events (TEAEs) | Baseline (week 0) to week 75 | An adverse event (AE) was defined as any unfavorable 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 treatment emergent adverse events (TEAE) defined as an event for which the onset of the event occurs in the on-treatment period. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period). |
| Number of Serious Adverse Events (SAEs) | Baseline (week 0) to week 75 | A serious adverse event (SAE) is 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 75 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period). |
| Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no) | Week 68 | Number of participants who achieved weight loss more than or equal to (≥) 10% at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75). |
| Change in Amylase - Ratio to Baseline | Baseline (week 0) to week 68 | Change in amylase (measured as units per litre \[U/L\]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period). |
| Change in Lipase - Ratio to Baseline | Baseline (week 0) to week 68 | Change in lipase (measured as units per litre \[U/L\]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period). |
| Change in Calcitonin - Ratio to Baseline | Baseline (week 0) to week 68 | Change in calcitonin (measured as ng/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period). |
| Change in Pulse | Baseline (week 0) to week 68 | Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period). |
| Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no) | Week 68 | Number of participants who achieved more than or equal to (≥) 15% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). |
Countries
Argentina, Belgium, Bulgaria, Canada, Denmark, Finland, France, Germany, India, Japan, Mexico, Poland, Puerto Rico, Russia, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
The trial was conducted at 129 sites in 16 countries as follows (all sites screened and randomized): Argentina (5 sites), Belgium (5 sites), Bulgaria (5 sites), Canada (7 sites), Denmark (1 site), Finland (2 sites), France (7 sites), Germany (13 sites), India (13 sites), Japan (5 sites), Mexico (3 sites), Poland (4 sites), Russian Federation (8 sites), Taiwan(1 site), UK (10 sites), US (40 sites).
Pre-assignment details
The trial included an initial 16-week dose-escalation period and a 52-week dose maintenance period. Participants were randomized in 2:1 ratio either to receive semaglutide 2.4 mg or placebo. The treatment is an adjunct to reduced-calorie diet and increased physical activity.
Participants by arm
| Arm | Count |
|---|---|
| Semaglutide 2.4 mg Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | 1,306 |
| Placebo Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | 655 |
| Total | 1,961 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 39 | 28 |
| Overall Study | Withdrawal by Subject | 26 | 17 |
Baseline characteristics
| Characteristic | Placebo | Total | Semaglutide 2.4 mg |
|---|---|---|---|
| Age, Continuous | 47 Years STANDARD_DEVIATION 12 | 46 Years STANDARD_DEVIATION 13 | 46 Years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 86 Participants | 236 Participants | 150 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 551 Participants | 1669 Participants | 1118 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 18 Participants | 56 Participants | 38 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 10 Participants | 27 Participants | 17 Participants |
| Race (NIH/OMB) Asian | 80 Participants | 261 Participants | 181 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 111 Participants | 72 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 33 Participants | 25 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants | 55 Participants | 38 Participants |
| Race (NIH/OMB) White | 499 Participants | 1472 Participants | 973 Participants |
| Sex: Female, Male Female | 498 Participants | 1453 Participants | 955 Participants |
| Sex: Female, Male Male | 157 Participants | 508 Participants | 351 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 1,306 | 1 / 655 |
| other Total, other adverse events | 1,052 / 1,306 | 447 / 655 |
| serious Total, serious adverse events | 128 / 1,306 | 42 / 655 |
Outcome results
Primary
Change in Body Weight (%)
Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Time frame: Baseline (week 0) to week 68
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Weight (%) | On-treatment observation period | -16.9 Percentage point | Standard Deviation 9.4 |
| Semaglutide 2.4 mg | Change in Body Weight (%) | In-trial observation period | -15.6 Percentage point | Standard Deviation 10.1 |
| Placebo | Change in Body Weight (%) | In-trial observation period | -2.8 Percentage point | Standard Deviation 6.5 |
| Placebo | Change in Body Weight (%) | On-treatment observation period | -3.1 Percentage point | Standard Deviation 6.4 |
Comparison: Treatment policy estimandp-value: <0.000195% CI: [-13.37, -11.51]ANCOVA
Comparison: Hypothetical estimandp-value: <0.000195% CI: [-15.29, -13.55]ANCOVA
Primary
Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no)
Number of participants who achieved weight loss more than or equal to 5% (yes/no) at week 68 are presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption.
Time frame: After week 68
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Semaglutide 2.4 mg | Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | In-trial observation period | No | 165 Participants |
| Semaglutide 2.4 mg | Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | On-treatment observation period | Yes | 978 Participants |
| Semaglutide 2.4 mg | Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | On-treatment observation period | No | 81 Participants |
| Semaglutide 2.4 mg | Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | In-trial observation period | Yes | 1047 Participants |
| Placebo | Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | In-trial observation period | Yes | 182 Participants |
| Placebo | Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | In-trial observation period | No | 395 Participants |
| Placebo | Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | On-treatment observation period | No | 334 Participants |
| Placebo | Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) | On-treatment observation period | Yes | 165 Participants |
Comparison: Treatment policy estimandp-value: <0.000195% CI: [8.88, 14.19]Regression, Logistic
Comparison: Hypothetical estimandp-value: <0.000195% CI: [28.02, 48.95]Regression, Logistic
Secondary
Change in Amylase - Ratio to Baseline
Change in amylase (measured as units per litre \[U/L\]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Time frame: Baseline (week 0) to week 68
Population: SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Amylase - Ratio to Baseline | 1.14 Ratio of amylase | Geometric Coefficient of Variation 21.6 |
| Placebo | Change in Amylase - Ratio to Baseline | 1.03 Ratio of amylase | Geometric Coefficient of Variation 21.4 |
Secondary
Change in Body Composition (Lean Body Mass) (%)
Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Composition (Lean Body Mass) (%) | 3.4 Percentage point | Standard Deviation 5.1 |
| Placebo | Change in Body Composition (Lean Body Mass) (%) | 0.2 Percentage point | Standard Deviation 2.7 |
Secondary
Change in Body Composition (Lean Body Mass) (kg)
Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Composition (Lean Body Mass) (kg) | -5.8 Kilograms | Standard Deviation 4.6 |
| Placebo | Change in Body Composition (Lean Body Mass) (kg) | -1.8 Kilograms | Standard Deviation 2.5 |
Secondary
Change in Body Composition (Total Fat Mass) (%)
Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Composition (Total Fat Mass) (%) | -3.9 Percentage point | Standard Deviation 5.4 |
| Placebo | Change in Body Composition (Total Fat Mass) (%) | -0.3 Percentage point | Standard Deviation 2.8 |
Secondary
Change in Body Composition (Total Fat Mass) (kg)
Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Composition (Total Fat Mass) (kg) | -9.3 Kilograms | Standard Deviation 8.5 |
| Placebo | Change in Body Composition (Total Fat Mass) (kg) | -1.5 Kilograms | Standard Deviation 5.1 |
Secondary
Change in Body Composition (Visceral Fat Mass) (%)
Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Composition (Visceral Fat Mass) (%) | -2.2 Percentage point | Standard Deviation 4.4 |
| Placebo | Change in Body Composition (Visceral Fat Mass) (%) | -0.1 Percentage point | Standard Deviation 4.5 |
Secondary
Change in Body Composition (Visceral Fat Mass) (kg)
Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Composition (Visceral Fat Mass) (kg) | -0.4 Kilograms | Standard Deviation 0.3 |
| Placebo | Change in Body Composition (Visceral Fat Mass) (kg) | -0.1 Kilograms | Standard Deviation 0.3 |
Secondary
Change in Body Mass Index (BMI) (kg/m2)
Change in body mass index from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Mass Index (BMI) (kg/m2) | -5.8 Kilogram per square meter (kg/sqm) | Standard Deviation 3.8 |
| Placebo | Change in Body Mass Index (BMI) (kg/m2) | -1.0 Kilogram per square meter (kg/sqm) | Standard Deviation 2.5 |
Secondary
Change in Body Weight (%) - DEXA Subpopulation
Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Weight (%) - DEXA Subpopulation | -15.8 Percentage point | Standard Deviation 11.1 |
| Placebo | Change in Body Weight (%) - DEXA Subpopulation | -3.4 Percentage point | Standard Deviation 6.1 |
Secondary
Change in Body Weight (kg)
Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Weight (kg) | -16.1 Kilogram (kg) | Standard Deviation 10.6 |
| Placebo | Change in Body Weight (kg) | -2.9 Kilogram (kg) | Standard Deviation 7.2 |
Secondary
Change in Body Weight (kg) - DEXA Subpopulation
Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Weight (kg) - DEXA Subpopulation | -15.5 Kilograms | Standard Deviation 11.4 |
| Placebo | Change in Body Weight (kg) - DEXA Subpopulation | -3.2 Kilograms | Standard Deviation 6.1 |
Secondary
Change in Calcitonin - Ratio to Baseline
Change in calcitonin (measured as ng/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Time frame: Baseline (week 0) to week 68
Population: SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Calcitonin - Ratio to Baseline | 0.99 Ratio of calcitonin | Geometric Coefficient of Variation 37.6 |
| Placebo | Change in Calcitonin - Ratio to Baseline | 0.95 Ratio of calcitonin | Geometric Coefficient of Variation 40.9 |
Secondary
Change in Diastolic Blood Pressure (mmHg)
Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Diastolic Blood Pressure (mmHg) | -3 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Placebo | Change in Diastolic Blood Pressure (mmHg) | -1 Millimeters of mercury (mmHg) | Standard Deviation 9 |
Secondary
Change in Fasting Plasma Glucose (FPG) (mg/dL)
Change in fasting plasma glucose from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Fasting Plasma Glucose (FPG) (mg/dL) | -9.2 milligrams per deciliter (mg/dL) | Standard Deviation 10.9 |
| Placebo | Change in Fasting Plasma Glucose (FPG) (mg/dL) | -0.4 milligrams per deciliter (mg/dL) | Standard Deviation 12.7 |
Secondary
Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline
Change in fasting serum insulin from week 0 to week 68 is presented as ratio to baseline. Fasting serum insulin was measured in milli-international units per milliliter (mIU/mL). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline | 0.73 Ratio of fasting serum insulin | Geometric Coefficient of Variation 62.3 |
| Placebo | Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline | 0.92 Ratio of fasting serum insulin | Geometric Coefficient of Variation 56.5 |
Secondary
Change in Free Fatty Acids (mg/dL) - Ratio to Baseline
Change in fasting free fatty acids from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Free Fatty Acids (mg/dL) - Ratio to Baseline | 0.83 Ratio of free fatty acids | Geometric Coefficient of Variation 78.3 |
| Placebo | Change in Free Fatty Acids (mg/dL) - Ratio to Baseline | 0.93 Ratio of free fatty acids | Geometric Coefficient of Variation 70.8 |
Secondary
Change in HbA1C (%)
Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in HbA1C (%) | -0.5 Percentage point of HbA1c | Standard Deviation 0.3 |
| Placebo | Change in HbA1C (%) | -0.2 Percentage point of HbA1c | Standard Deviation 0.3 |
Secondary
Change in HbA1C (mmol/Mol)
Change in HbA1c from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in HbA1C (mmol/Mol) | -5.1 millimoles per mole (mmol/mol) | Standard Deviation 3.3 |
| Placebo | Change in HbA1C (mmol/Mol) | -1.8 millimoles per mole (mmol/mol) | Standard Deviation 3 |
Secondary
Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline
Change in fasting HDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline | 1.05 Ratio of HDL cholesterol | Geometric Coefficient of Variation 16.1 |
| Placebo | Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline | 1.02 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.9 |
Secondary
Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline
Change in high sensitivity C-reactive protein from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline | 0.45 Ratio of hsCRP | Geometric Coefficient of Variation 128.2 |
| Placebo | Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline | 0.84 Ratio of hsCRP | Geometric Coefficient of Variation 102.5 |
Secondary
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score
IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. It is used to assess the impact of body weight changes on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 2.4 mg | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score | Change in physical domain score | 14.0 Score on a scale | Standard Deviation 20 |
| Semaglutide 2.4 mg | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score | Change in total score | 16.2 Score on a scale | Standard Deviation 17.8 |
| Semaglutide 2.4 mg | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score | Change in psychosocial domain score | 17.4 Score on a scale | Standard Deviation 19.2 |
| Semaglutide 2.4 mg | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score | Change in physical function domain score | 15.0 Score on a scale | Standard Deviation 21.6 |
| Placebo | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score | Change in psychosocial domain score | 6.9 Score on a scale | Standard Deviation 17.8 |
| Placebo | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score | Change in physical domain score | 5.0 Score on a scale | Standard Deviation 19.5 |
| Placebo | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score | Change in physical function domain score | 6.0 Score on a scale | Standard Deviation 21.1 |
| Placebo | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score | Change in total score | 6.3 Score on a scale | Standard Deviation 16.8 |
Secondary
Change in Leptin (ng/mL) - Ratio to Baseline
Change in leptin from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Leptin (ng/mL) - Ratio to Baseline | 0.52 Ratio of leptin | Geometric Coefficient of Variation 75.9 |
| Placebo | Change in Leptin (ng/mL) - Ratio to Baseline | 0.87 Ratio of leptin | Geometric Coefficient of Variation 52.7 |
Secondary
Change in Lipase - Ratio to Baseline
Change in lipase (measured as units per litre \[U/L\]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Time frame: Baseline (week 0) to week 68
Population: SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Lipase - Ratio to Baseline | 1.41 Ratio of lipase | Geometric Coefficient of Variation 49.3 |
| Placebo | Change in Lipase - Ratio to Baseline | 0.97 Ratio of lipase | Geometric Coefficient of Variation 37.3 |
Secondary
Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline
Change in fasting LDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline | 0.97 Ratio of LDL cholesterol | Geometric Coefficient of Variation 23.7 |
| Placebo | Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline | 1.01 Ratio of LDL cholesterol | Geometric Coefficient of Variation 25.5 |
Secondary
Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline
Change in plasminogen activator inhibitor-1 activity from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline | 1.15 Ratio of PAI-1 | Geometric Coefficient of Variation 86.5 |
| Placebo | Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline | 1.53 Ratio of PAI-1 | Geometric Coefficient of Variation 77.3 |
Secondary
Change in Pulse
Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Time frame: Baseline (week 0) to week 68
Population: SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Pulse | 3 beats per minute (bpm) | Standard Deviation 10 |
| Placebo | Change in Pulse | -1 beats per minute (bpm) | Standard Deviation 10 |
Secondary
Change in Short Form 36 (SF-36)
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 eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation, respectively, for the 2009 US general population. 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. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 2.4 mg | Change in Short Form 36 (SF-36) | Change in SF-36 (bodily pain score) | 0.5 Score on a scale | Standard Deviation 8.2 |
| Semaglutide 2.4 mg | Change in Short Form 36 (SF-36) | Change in SF-36 (role-emotional score) | -0.9 Score on a scale | Standard Deviation 7.3 |
| Semaglutide 2.4 mg | Change in Short Form 36 (SF-36) | Change in physical functioning score (SF-36) | 2.3 Score on a scale | Standard Deviation 6.6 |
| Semaglutide 2.4 mg | Change in Short Form 36 (SF-36) | Change in SF-36 (role-physical score) | 1.1 Score on a scale | Standard Deviation 7.2 |
| Semaglutide 2.4 mg | Change in Short Form 36 (SF-36) | Change in SF-36 (general health score) | 2.0 Score on a scale | Standard Deviation 7.2 |
| Semaglutide 2.4 mg | Change in Short Form 36 (SF-36) | Change in SF-36 (vitality score) | 0.7 Score on a scale | Standard Deviation 8 |
| Semaglutide 2.4 mg | Change in Short Form 36 (SF-36) | Change in SF-36 (social functioning score) | -0.3 Score on a scale | Standard Deviation 6.6 |
| Semaglutide 2.4 mg | Change in Short Form 36 (SF-36) | Change in SF-36 (mental health score) | -0.8 Score on a scale | Standard Deviation 7 |
| Semaglutide 2.4 mg | Change in Short Form 36 (SF-36) | Change in SF-36 (physical component summary) | 2.4 Score on a scale | Standard Deviation 6.7 |
| Semaglutide 2.4 mg | Change in Short Form 36 (SF-36) | Change in SF-36 (mental component summary) | -1.5 Score on a scale | Standard Deviation 7.1 |
| Placebo | Change in Short Form 36 (SF-36) | Change in SF-36 (mental health score) | -1.7 Score on a scale | Standard Deviation 7.4 |
| Placebo | Change in Short Form 36 (SF-36) | Change in SF-36 (vitality score) | -1.3 Score on a scale | Standard Deviation 7.9 |
| Placebo | Change in Short Form 36 (SF-36) | Change in SF-36 (role-emotional score) | -1.5 Score on a scale | Standard Deviation 7.6 |
| Placebo | Change in Short Form 36 (SF-36) | Change in SF-36 (mental component summary) | -2.1 Score on a scale | Standard Deviation 7.7 |
| Placebo | Change in Short Form 36 (SF-36) | Change in physical functioning score (SF-36) | 0.4 Score on a scale | Standard Deviation 7.4 |
| Placebo | Change in Short Form 36 (SF-36) | Change in SF-36 (social functioning score) | -1.4 Score on a scale | Standard Deviation 7.4 |
| Placebo | Change in Short Form 36 (SF-36) | Change in SF-36 (role-physical score) | -0.2 Score on a scale | Standard Deviation 7.2 |
| Placebo | Change in Short Form 36 (SF-36) | Change in SF-36 (bodily pain score) | -1.3 Score on a scale | Standard Deviation 8.9 |
| Placebo | Change in Short Form 36 (SF-36) | Change in SF-36 (physical component summary) | 0.2 Score on a scale | Standard Deviation 7.1 |
| Placebo | Change in Short Form 36 (SF-36) | Change in SF-36 (general health score) | -0.6 Score on a scale | Standard Deviation 7.1 |
Secondary
Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline
Change in soluble leptin receptor from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline | 1.07 Ratio of soluble leptin receptor | Geometric Coefficient of Variation 24.9 |
| Placebo | Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline | 1.02 Ratio of soluble leptin receptor | Geometric Coefficient of Variation 22.2 |
Secondary
Change in Systolic Blood Pressure (mmHg)
Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Systolic Blood Pressure (mmHg) | -7 Millimeters of mercury (mmHg) | Standard Deviation 14 |
| Placebo | Change in Systolic Blood Pressure (mmHg) | -1 Millimeters of mercury (mmHg) | Standard Deviation 13 |
Secondary
Change in Total Cholesterol (mg/dL) - Ratio to Baseline
Change in fasting total cholesterol from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Total Cholesterol (mg/dL) - Ratio to Baseline | 0.96 Ratio of total cholesterol | Geometric Coefficient of Variation 14.8 |
| Placebo | Change in Total Cholesterol (mg/dL) - Ratio to Baseline | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 15.5 |
Secondary
Change in Triglycerides (mg/dL) - Ratio to Baseline
Change in fasting triglycerides from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Triglycerides (mg/dL) - Ratio to Baseline | 0.77 Ratio of triglycerides | Geometric Coefficient of Variation 38.3 |
| Placebo | Change in Triglycerides (mg/dL) - Ratio to Baseline | 0.92 Ratio of triglycerides | Geometric Coefficient of Variation 36.2 |
Secondary
Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline
Change in fasting VLDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline | 0.77 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 37.7 |
| Placebo | Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline | 0.92 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 35.2 |
Secondary
Change in Waist Circumference (cm)
Change in waist circumference from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).
Time frame: Baseline (week 0) to week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Waist Circumference (cm) | -14.1 Centimeter (cm) | Standard Deviation 9.6 |
| Placebo | Change in Waist Circumference (cm) | -4.4 Centimeter (cm) | Standard Deviation 6.9 |
Secondary
Number of Serious Adverse Events (SAEs)
A serious adverse event (SAE) is 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 75 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
Time frame: Baseline (week 0) to week 75
Population: SAS included all participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 2.4 mg | Number of Serious Adverse Events (SAEs) | 164 Events |
| Placebo | Number of Serious Adverse Events (SAEs) | 53 Events |
Secondary
Number of Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any unfavorable 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 treatment emergent adverse events (TEAE) defined as an event for which the onset of the event occurs in the on-treatment period. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
Time frame: Baseline (week 0) to week 75
Population: SAS included all participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 2.4 mg | Number of Treatment Emergent Adverse Events (TEAEs) | 9658 Events |
| Placebo | Number of Treatment Emergent Adverse Events (TEAEs) | 3302 Events |
Secondary
Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no)
Number of participants who achieved more than or equal to (≥) 15% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no) | Yes | 612 Participants |
| Semaglutide 2.4 mg | Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no) | No | 600 Participants |
| Placebo | Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no) | Yes | 28 Participants |
| Placebo | Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no) | No | 549 Participants |
Secondary
Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no)
Number of participants who achieved more than or equal to (≥) 20% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
Time frame: Week 68
Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no) | Yes | 388 Participants |
| Semaglutide 2.4 mg | Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no) | No | 824 Participants |
| Placebo | Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no) | No | 567 Participants |
| Placebo | Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no) | Yes | 10 Participants |
Secondary
Participants Who Achieve Responder Definition Value (Yes/no) 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. In trial observation period: the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
Time frame: After week 68
Population: FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Participants Who Achieve Responder Definition Value (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score | Yes (with threshold 14.6) | 611 Participants |
| Semaglutide 2.4 mg | Participants Who Achieve Responder Definition Value (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score | Yes (with threshold 20) | 473 Participants |
| Semaglutide 2.4 mg | Participants Who Achieve Responder Definition Value (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score | No (with threshold 14.6) | 582 Participants |
| Semaglutide 2.4 mg | Participants Who Achieve Responder Definition Value (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score | No (with threshold 20) | 720 Participants |
| Placebo | Participants Who Achieve Responder Definition Value (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score | No (with threshold 14.6) | 380 Participants |
| Placebo | Participants Who Achieve Responder Definition Value (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score | No (with threshold 20) | 421 Participants |
| Placebo | Participants Who Achieve Responder Definition Value (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score | Yes (with threshold 14.6) | 186 Participants |
| Placebo | Participants Who Achieve Responder Definition Value (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score | Yes (with threshold 20) | 145 Participants |
Secondary
Participants Who Achieve Responder Definition Value (Yes/no) 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 different 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 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 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 is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
Time frame: After week 68
Population: FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Participants Who Achieve Responder Definition Value (Yes/no) for SF-36 Physical Functioning Score | Yes (with threshold 4.3) | 318 Participants |
| Semaglutide 2.4 mg | Participants Who Achieve Responder Definition Value (Yes/no) for SF-36 Physical Functioning Score | Yes (with threshold 3.7) | 478 Participants |
| Semaglutide 2.4 mg | Participants Who Achieve Responder Definition Value (Yes/no) for SF-36 Physical Functioning Score | No (with threshold 3.7) | 717 Participants |
| Semaglutide 2.4 mg | Participants Who Achieve Responder Definition Value (Yes/no) for SF-36 Physical Functioning Score | No (with threshold 4.3) | 877 Participants |
| Placebo | Participants Who Achieve Responder Definition Value (Yes/no) for SF-36 Physical Functioning Score | No (with threshold 3.7) | 413 Participants |
| Placebo | Participants Who Achieve Responder Definition Value (Yes/no) for SF-36 Physical Functioning Score | Yes (with threshold 3.7) | 153 Participants |
| Placebo | Participants Who Achieve Responder Definition Value (Yes/no) for SF-36 Physical Functioning Score | No (with threshold 4.3) | 469 Participants |
| Placebo | Participants Who Achieve Responder Definition Value (Yes/no) for SF-36 Physical Functioning Score | Yes (with threshold 4.3) | 97 Participants |
Secondary
Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no)
Number of participants who achieved weight loss more than or equal to (≥) 10% at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75).
Time frame: Week 68
Population: FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no) | No | 374 Participants |
| Semaglutide 2.4 mg | Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no) | Yes | 838 Participants |
| Placebo | Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no) | Yes | 69 Participants |
| Placebo | Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no) | No | 508 Participants |