Efficacy and Safety of Tirzepatide Monotherapy in Type 2 Diabetes (SURPASS-1)
Summary
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.
Key Findings
- 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
- Body weight reductions ranged from 7.0 kg to 9.5 kg across tirzepatide dose groups vs 0.7 kg with placebo
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Jastreboff AM, Aronne LJ, Ahmad NN, et al.
New England Journal of Medicine
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.
- 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