Completed Phase III 2021

    Once-Weekly Semaglutide in Adults with Overweight or Obesity

    Wilding JPH, Batterham RL, Calanna S, et al.

    New England Journal of Medicine

    DOI: 10.1056/NEJMoa2032183

    Summary

    The STEP 1 trial was a 68-week, randomized, double-blind, placebo-controlled trial evaluating once-weekly subcutaneous semaglutide 2.4 mg for weight management in 1,961 adults with a BMI of 30 or greater (or 27 or greater with at least one weight-related comorbidity) without diabetes. Participants receiving semaglutide achieved a mean body weight reduction of 14.9% compared to 2.4% with placebo.

    Key Findings

    • Mean change in body weight was -14.9% with semaglutide vs -2.4% with placebo at 68 weeks
    • 86.4% of semaglutide participants achieved at least 5% weight loss, and 69.1% achieved at least 10% weight loss
    • Semaglutide led to significant improvements in cardiometabolic risk factors including waist circumference, blood pressure, C-reactive protein, and lipid levels

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    Completed 2016

    Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes

    Marso SP, Bain SC, Consoli A, et al.

    New England Journal of Medicine

    The SUSTAIN-6 trial was a randomized, double-blind, placebo-controlled cardiovascular outcomes trial evaluating subcutaneous semaglutide (0.5 mg or 1.0 mg weekly) in 3,297 patients with type 2 diabetes at high cardiovascular risk over a median of 2.1 years. Semaglutide significantly reduced the primary composite endpoint of major adverse cardiovascular events (MACE) by 26%.

    • Semaglutide reduced the primary MACE composite endpoint (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke) by 26% compared to placebo (HR 0.74, 95% CI 0.58-0.95)
    • Non-fatal stroke was reduced by 39% and non-fatal myocardial infarction by 26% in the semaglutide group

    DOI: 10.1056/NEJMoa1607141