Novo Nordisk announces positive topline results from its phase 3 REIMAGINE 5 and REDEFINE 9 trials for CagriSema. The investigational dual-action therapy outperforms Eli Lilly's tirzepatide 5 mg, achieving 12.4% weight loss versus 9.1% in adults with type 2 diabetes, while matching its blood sugar reduction. In obesity trials, CagriSema 1.0 mg/1.0 mg delivers a 21.0% weight reduction. Novo Nordisk expects an FDA approval decision in the fourth quarter of 2026.
CagriSema phase 3 trial results
- ▪In the phase 3 REDEFINE 9 trial, Novo Nordisk's CagriSema 1.0 mg/1.0 mg achieved an average weight reduction of 21.0% at week 68 compared to 2.0% for placebo in adults with overweight or obesity.
- ▪In the phase 3 REDEFINE 9 trial, Novo Nordisk's CagriSema demonstrated greater improvements than placebo in systolic blood pressure, waist-to-height ratio, and fasting lipid profile.
Head-to-head comparison with tirzepatide
- ▪In the phase 3 REIMAGINE 5 trial, Novo Nordisk's CagriSema 1.0 mg/1.0 mg achieved an estimated average weight loss of 12.4% at week 60 compared to 9.1% for Eli Lilly's tirzepatide 5 mg in adults with type 2 diabetes.
- ▪In the phase 3 REIMAGINE 5 trial, Novo Nordisk's CagriSema 1.0 mg/1.0 mg demonstrated a non-inferior HbA1c reduction of 1.71% compared to 1.67% for Eli Lilly's tirzepatide 5 mg at week 60.
Dual mechanism of action
- ▪Novo Nordisk executive vice president Martin Holst Lange stated that the trial results demonstrate the strong potency of combining semaglutide and cagrilintide and add to the growing evidence for amylin biology.
- ▪Novo Nordisk's investigational once-weekly subcutaneous treatment CagriSema is a fixed-dose combination of the long-acting amylin receptor agonist cagrilintide and the GLP-1 receptor agonist semaglutide.
FDA regulatory timeline
- ▪Novo Nordisk expects a regulatory decision from the U.S. Food and Drug Administration regarding CagriSema in the fourth quarter of 2026.
- ▪Novo Nordisk filed a New Drug Application with the U.S. Food and Drug Administration in December 2025 for CagriSema for weight management.
Individualized dosing strategy
- ▪Novo Nordisk stated that the CagriSema trial data provide evidence of efficacy at the 1.0 mg/1.0 mg dose, expanding options for individualized care as not all patients remain on the highest available doses of current therapies.
- ▪The phase 3 REDEFINE 9 trial investigated both CagriSema 1.7 mg/1.7 mg and CagriSema 1.0 mg/1.0 mg compared with placebo as an adjunct to a reduced-calorie diet and increased physical activity.
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