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Description
Study Population : 1,961 adults without diabetes Average age: 46 years Average baseline BMI: 37.9 Average baseline weight: 231.3 pounds 74.1% female, 25.9% male 76.6% White, 11.6% Black, 7.0% Asian, 4.8% Other Intervention : Semaglutide 2.4 mg subcutaneously once weekly (n=1,306) Placebo subcutaneously once weekly (n=655) Both groups: Individual counseling sessions every 4 weeks promoting 500-calorie deficit and 150 minutes/week physical activity Duration : 68 weeks Primary Outcome - Mean Percentage Weight Loss : Semaglutide: -14.9% (95% CI: -15.3 to -14.5) Placebo: -2.4% (95% CI: -3.0 to -1.8) Difference: -12.4 percentage points (p0.001) Secondary Outcomes - Categorical Weight Loss : 5% weight loss : 86.4% semaglutide vs 31.5% placebo 10% weight loss : 69.1% semaglutide vs 12.0% placebo 15% weight loss : 50.5% semaglutide vs 4.9% placebo 20% weight loss : 32.0% semaglutide vs 1.7% placebo Trial Completion Rates : Semaglutide: 81.7% completed 68 weeks Placebo: 82.0% completed 68 weeks High completion rates suggest good tolerability and participant satisfaction Safety Data : Gastrointestinal adverse events: 74.2% semaglutide vs 47.9% placebo Serious adverse events: 9.8% semaglutide vs 6.4% placebo Discontinuation due to adverse events: 7.0% semaglutide vs 3.1% placebo STEP 2: Diabetes Population Trial Citation : Davies M, et al

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J Hepatol (2011) 54:121423
