CagriSema misses non-inferiority goal against tirzepatide in REDEFINE 4
In the open-label phase 3 REDEFINE 4 trial of 809 adults with obesity, CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg) produced 23.0% average weight loss at 84 weeks versus 25.5% with tirzepatide 15 mg among people adhering to treatment, or 20.2% versus 23.6% regardless of adherence. The trial therefore did not meet its primary goal of showing CagriSema was not inferior to tirzepatide. Novo Nordisk had filed CagriSema with the FDA in December 2025.
Sources
- 01CagriSema demonstrated 23% weight loss in an open-label head-to-head REDEFINE 4 trial in people with obesity, the primary endpoint was not achieved(opens the source in a new tab)
- 02Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management(opens the source in a new tab)