Semaglutide high dose for weight reduction in people with Type 2 Diabetes
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Key Takeaway
Note that weight loss results for semaglutide in this trial are not reported in the abstract.
This Phase 3 randomized controlled trial (preprint) enrolled 512 people with excess weight and Type 2 Diabetes. The intervention was high-dose semaglutide, with comparator arms of placebo and lower-dose semaglutide. The primary outcomes were relative change in body weight and the number of participants achieving a body weight reduction of at least 5% over a follow-up of 21.8 months.
The main results for both primary outcomes were not reported in the abstract. Specific effect sizes, absolute numbers, p-values, and confidence intervals were not provided. The direction of effect is therefore unknown.
Safety and tolerability data, including adverse events, serious adverse events, and discontinuations, were not reported in the abstract. Key limitations include the lack of reported results, which precludes any assessment of efficacy or safety. The lead sponsor was Novo Nordisk A/S.
Practice relevance is not reported. Causality cannot be inferred from the abstract alone, and certainty is low. This summary is based solely on the provided abstract information.
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View Original Abstract ↓
Status: COMPLETED | Phase: PHASE3
Condition(s): Obesity, Diabetes Mellitus, Type 2
Intervention(s): Semaglutide (DRUG), Semaglutide (DRUG), Placebo (DRUG)
This study will look at how much weight participants will lose and how much blood sugar control they achieve 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. After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose. The study will last for about 1.5 years
Primary Outcome(s): Relative Change in Body Weight; Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)
Enrollment: 512 (ACTUAL)
Lead Sponsor: Novo Nordisk A/S
Start: 2023-01-04 | Primary Completion: 2024-10-28
Results posted: 2026-04-27
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