Human randomized trialNew England Journal of Medicine · 2021
Once-weekly semaglutide in adults with overweight or obesity
Phase 3, randomized, double-blind, placebo-controlled trial (STEP 1).
Who or what was studied.
Adults with obesity (BMI ≥ 30), or overweight (BMI ≥ 27) with at least one comorbidity, excluding diabetes.1,961 randomized participants.68 weeks of treatment.
Main findings.
Semaglutide 2.4 mg once weekly produced a mean body-weight change of −14.9% over 68 weeks, versus −2.4% with placebo. In total, 86.4% of semaglutide participants achieved at least 5% weight loss versus 31.5% of placebo participants.
Limitations.
Key limitations: follow-up ended at 68 weeks, leaving longer-term maintenance and safety unanswered; gastrointestinal adverse events were more frequent with semaglutide than placebo; and the trial was not designed to compare semaglutide against other weight-management pharmacotherapies.
Compounds & topics.
semaglutideobesitybody compositionmetabolic research
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