CagriSema

Overview

CagriSema is Novo Nordisk's investigational once-weekly fixed-dose co-formulation of cagrilintide 2.4 mg (long-acting amylin analog) with semaglutide 2.4 mg (GLP-1 receptor agonist) for chronic weight management. Unlike the other grey-market blends, it has a proper Phase 3 clinical program. Novo Nordisk filed an FDA NDA in December 2025; as of April 2026 it is under FDA review and not yet approved.

Mechanism of Action

Dual-hormone appetite regulation: cagrilintide provides amylin-receptor-mediated satiety and slowed gastric emptying; semaglutide provides GLP-1-receptor-mediated appetite suppression and glucose-dependent insulin release. Combining amylin and GLP-1 pathways is the pharmacological rationale driving Phase 3 testing.

Research Summary

Phase 3 REDEFINE program: REDEFINE-1 (obesity without T2D, 68 weeks, n=3,417) reported 20.4% mean weight loss on CagriSema vs 3.0% placebo (22.7% under full-adherence analysis), published NEJM June 2025. REDEFINE-2 (obesity with T2D) reported ~13.7% weight loss vs 3.4% placebo. REDEFINE-3 is an ongoing cardiovascular outcomes trial. FDA NDA filed December 2025; PDUFA decision expected around October 2026.

Dosing Information

Reported Side Effects

• See individual cagrilintide and semaglutide profiles

Research References

• Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1) (2025)
• Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (REDEFINE 2) (2025)