CagriSema fails non-inferiority versus tirzepatide in head-to-head REDEFINE 4

In the open-label REDEFINE 4 trial, CagriSema produced 23.0% weight loss at 84 weeks on the adherent-patient measure, against 25.5% for tirzepatide 15 mg from Eli Lilly. The primary endpoint of non-inferiority was not met, which is a clear setback for Novo's next-generation obesity drug. The US filing for CagriSema is still under review with a decision expected by late 2026.

• Efficacy estimand: CagriSema 23.0% vs tirzepatide 25.5% weight loss
• Treatment-regimen estimand: 20.2% vs 23.6%
• 809 adults, open-label, 84 weeks
• US FDA decision on CagriSema for weight management expected by late 2026