Garvey 2025 — REDEFINE 1 Cagrilintide-Semaglutide in Adults With Overweight or Obesity

New England Journal of Medicine·August 14, 2025

W. Timothy Garvey, Matthias Blüher, Cynthia Karenina Osorto Contreras, Melanie J. Davies, Eva Winning Lehmann, Kirsi H. Pietiläinen, Domenica Rubino, Paolo Sbraccia, Thomas A. Wadden, REDEFINE 1 Study Group

Summary

Cagrilintide-semaglutide produced clinically significant body-weight reduction versus placebo, with greater likelihood of reaching 5%, 20%, 25%, and 30% weight-loss thresholds.

Study Details

Study Design

Phase 3a multicenter randomized double-blind placebo-controlled and active-controlled trial

Indication

Overweight or obesity without diabetes

Intervention

Cagrilintide 2.4 mg plus semaglutide 2.4 mg vs semaglutide, cagrilintide, or placebo

Species

Human

Sample Size

3,417 subjects

Risk of Bias Assessment

Sponsor-funded; phase 3 active-controlled trial