Phase 3 trial with dual GIP and GLP-1 receptor agonist meets primary endpoints

News - May 1, 2023

The phase 3 SURMOUNT-2 trial met its co-primary endpoints of body weight reduction as well as key secondary endpoints. In SURMOUNT-2, the efficacy and safety of tirzapatide, a novel glucose-dependent insulinotropic polypeptide and GLP-1 receptor agonist, was evaluated.

Patients with obesity or overweight and TDM2 taking tirzepatide achieved up to 15.7% (34.4 lb. or 15.6 kg) weight loss at 72 weeks compared to 3.3% (7.0 lb. or 3.2 kg) in the placebo group. The vast majority of patients in the tirzepatide group achieved ≥5% of body weight reduction (81.6% and 86.4% in the tirzepatide group (dose of 10 mg and 15 mg, respectively) compared to 30.5% in the placebo group). Tirzepatide had a similar safety profile as previously reported in the SURMOUNT and SURPASS trials and to incretin-based therapies approved for the treatment of obesity and overweight.

SURMOUNT-2 was a multi-center, randomized, double-blind, parallel, placebo-controlled trial, with 938 adults with obesity or overweight and T2D. Participants received tirzepatide (10 mg or 15 mg) or placebo. The co-primary endpoint was the percentage change in body weight from baseline and the percentage of participants achieving ≥5% body weight reduction at 72 weeks compared to placebo. All participants receiving tirzepatide started at a once-weekly dose of 2.5 mg, and increased in a step-wise manner over a four week period to their final randomized maintenance dose of 10 mg or 15 mg.

The SURMOUNT-2 results will be presented at the American Diabetes Association's 83rd Scientific Sessions.

Source: Press release Lilly, April 27, 2023

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