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Novo Nordisk Advances Amylin Obesity Drug After Phase 3 Data Show Double-Digit Weight Loss

Executives also signal an FDA filing for a higher‑dose Wegovy.

Overview

  • The REDEFINE 1 sub‑analysis found once‑weekly cagrilintide 2.4 mg cut body weight by an average 11.8% at 68 weeks versus 2.3% with placebo, with 31.6% achieving at least 15% loss.
  • Cagrilintide was generally well‑tolerated, with mostly transient, mild‑to‑moderate gastrointestinal events, and nausea led to discontinuation in 1.0% on drug versus 0.1% on placebo.
  • Novo Nordisk will start the dedicated phase 3 RENEW program in the fourth quarter of 2025 to further evaluate cagrilintide in people with overweight or obesity.
  • Cagrilintide is a long‑acting amylin analogue that acts via a mechanism distinct from GLP‑1 therapies such as semaglutide.
  • Company leaders said they intend to seek U.S. approval for a higher‑dose Wegovy and described plans to study future weight‑loss drugs across obesity‑linked conditions, while shares rose after the data release.