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Pivotal 68-week trial that earned Wegovy its FDA weight-loss approval. Average 14.9% body weight loss vs 2.4% placebo.
STEP 1 (Semaglutide Treatment Effect in People with Obesity) randomized 1,961 adults with overweight (plus comorbidity) or obesity to once-weekly semaglutide 2.4 mg or placebo for 68 weeks. Mean weight loss: 14.9% with semaglutide vs 2.4% placebo. 86.4% of semaglutide patients lost ≥5% body weight vs 31.5% of placebo. Pivotal trial supporting Wegovy's FDA approval. NEJM 2021.