Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 1,407
- Locations
- 106
- Primary Endpoint
- Semaglutide 7.2 mg versus Placebo: Relative change in body weight
Study Overview
Brief Summary
This study will look at how much weight participants will lose from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. In the first part of the study, participants will get one injection once a week until they reach the planned dose. The second part of the study, which might last a couple of months, is a transition period, where participant will get three injections, taken right after each other, once a week. The duration of the study intervention (trial product and lifestyle intervention) will be 72 weeks followed by a 9-week follow-up period without study interventions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female.
- •Age above or equal to 18 years at the time of signing informed consent.
- •Body mass index (BMI) greater than or equal to 30.0 kilogram per square meter (kg/m^2).
- •History of at least one self-reported unsuccessful dietary effort to lose body weight.
Exclusion Criteria
- •HbA1c greater than or equal to 48 millimoles per mole (mmol/mol) (6.5 percent) as measured by the central laboratory at screening.
- •History of type 1 or type 2 diabetes.
- •Treatment with glucose-lowering agent(s) within 90 days before screening.
- •A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening irrespective of medical records.
- •Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
Arms & Interventions
Semaglutide 7.2 mg
Participants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram [mg], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week. Treatment was continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72.
Intervention: Semaglutide (Drug)
Semaglutide 2.4 mg
Participants will receive once-weekly s.c. injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72.
Intervention: Semaglutide (Drug)
Placebo
Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Semaglutide 7.2 mg versus Placebo: Relative change in body weight
Time Frame: From baseline (week 0) to end of treatment (week 72)
Measured in percentage (%).
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction greater than or equal to (>=) 5% (yes/no)
Time Frame: From baseline (week 0) to end of treatment (week 72)
Measured as count of participants.
Secondary Outcomes
- Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=10% (yes/no)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Relative change in body weight(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in diastolic blood pressure(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=20% (yes/no)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=25% (yes/no)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=15% (yes/no)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in waist circumference(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of participants who achieve body weight reduction >=25% (yes/no)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in body weight(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in high-density lipoprotein (HDL) cholesterol(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of participants who achieve body weight reduction >=20% (yes/no)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in body mass index (BMI)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in total fat mass (%)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in lean body mass (%)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in visceral fat mass (%)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in total fat mass (liters)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in lean body mass (liters)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in visceral fat mass (liters)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in systolic blood pressure(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in fasting serum insulin(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in total cholesterol(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in very low-density lipoprotein (VLDL) cholesterol(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in triglycerides(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in free fatty acids(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in high-sensitivity c reactive protein (hsCRP)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Number of adverse events (AEs)(From baseline (week 0) to end of study (week 81))
- Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of AEs(From baseline (week 0) to end of study (week 81))
- Semaglutide 7.2 mg versus Placebo: Change in glycated haemoglobin (HbA1c)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Number of participants with change in lipid-lowering treatment (decrease, no change, increase)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in fasting plasma glucose(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Number of participants with change in antihypertensive treatment (decrease, no change, increase)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Number of participants with change in glycaemic category (Normo-glycaemia, pre-diabetes, type 2 diabetes [T2D])(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Number of serious adverse events (SAEs)(From baseline (week 0) to end of study (week 81))
- Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of SAEs(From baseline (week 0) to end of study (week 81))
- Semaglutide 7.2 mg versus Placebo: Change in pulse(From baseline (week 0) to end of treatment (week 72))