Completed Phase III 2022

    Tirzepatide Once Weekly for the Treatment of Obesity

    Jastreboff AM, Aronne LJ, Ahmad NN, et al.

    New England Journal of Medicine

    DOI: 10.1056/NEJMoa2206038

    Summary

    The SURMOUNT-1 trial was a 72-week, randomized, double-blind, placebo-controlled trial of once-weekly tirzepatide (5 mg, 10 mg, or 15 mg) in 2,539 adults with obesity or overweight with at least one weight-related complication, excluding diabetes. Tirzepatide produced substantial, dose-dependent weight reductions, with the 15 mg dose achieving a mean 22.5% reduction in body weight.

    Key Findings

    • Mean percentage change in body weight at 72 weeks was -15.0% (5 mg), -19.5% (10 mg), and -20.9% (15 mg) vs -3.1% with placebo
    • Over 90% of participants receiving tirzepatide 10 mg or 15 mg achieved at least 5% body weight reduction
    • Significant improvements in waist circumference, blood pressure, fasting lipids, and fasting insulin were observed across all tirzepatide doses

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    Completed 2021

    Efficacy and Safety of Tirzepatide Monotherapy in Type 2 Diabetes (SURPASS-1)

    Rosenstock J, Wysham C, Frias JP, et al.

    New England Journal of Medicine

    The SURPASS-1 trial evaluated the efficacy and safety of tirzepatide, a dual GIP/GLP-1 receptor agonist, as monotherapy in 478 adults with type 2 diabetes inadequately controlled by diet and exercise alone over 40 weeks. Tirzepatide at all doses (5 mg, 10 mg, and 15 mg) demonstrated superior reductions in HbA1c and body weight compared to placebo.

    • Tirzepatide reduced HbA1c by 1.87% (5 mg), 1.89% (10 mg), and 2.07% (15 mg) vs 0.04% increase with placebo
    • Up to 52% of participants in the 15 mg group achieved HbA1c below 5.7%, a level consistent with normoglycemia

    DOI: 10.1056/NEJMoa2032183