What Is CagriSema?
CagriSema is a fixed-dose combination of cagrilintide and semaglutide, both developed by Novo Nordisk. Cagrilintide is a long-acting analogue of amylin — a hormone co-secreted with insulin from pancreatic beta cells that plays a role in satiety, gastric emptying, and glucose regulation. By combining it with semaglutide, Novo Nordisk targets two complementary hormonal pathways simultaneously.
The Role of Amylin
Amylin works alongside insulin to regulate blood sugar and appetite. It slows gastric emptying, suppresses glucagon, and signals satiety to the brain through pathways partially distinct from GLP-1. A synthetic amylin analogue called pramlintide was previously approved (as Symlin) for use with insulin in diabetes, but its short half-life required multiple daily injections. Cagrilintide is engineered for once-weekly dosing, making it practical as part of a combination product.
Early Trial Results
Phase 2 results from the COMBINE 1 trial showed CagriSema producing approximately 15% weight reduction compared to approximately 10% for semaglutide alone at the doses studied. More extensive trials have shown weight loss approaching 25% at highest doses, positioning CagriSema as Novo Nordisk's answer to tirzepatide's efficacy advantage over Wegovy.
Current Status (Updated August 2026)
CagriSema has completed its pivotal Phase 3 program (REDEFINE trials). The REDEFINE-1 trial — the largest Phase 3 obesity trial — reported 22.7% average weight loss at 68 weeks with the highest dose combination. Novo Nordisk filed a New Drug Application (NDA) with the FDA on December 18, 2025. An FDA decision is expected in Q4 2026. CagriSema is not yet approved and is not available outside clinical trials. Expected launch price has been estimated at $1,400–$1,600 per month, though final pricing has not been announced.
CagriSema represents Novo Nordisk's strategy for competing with tirzepatide's efficacy advantage — targeting a second hormonal pathway (amylin) rather than a second incretin (GIP) as Lilly did with tirzepatide.
August 2026 Update: NDA Under FDA Review
NDA Filed December 2025 — FDA Decision Expected Q4 2026: Novo Nordisk submitted its New Drug Application for CagriSema in December 2025, backed by REDEFINE-1 Phase 3 data showing 22.7% weight loss at 68 weeks — the highest efficacy data from any obesity drug NDA submitted to the FDA to date. The FDA has accepted the NDA and a PDUFA decision date is expected in Q4 2026. If approved, CagriSema would become the first GLP-1 + amylin combination therapy and the second dual-mechanism obesity drug to reach market (after tirzepatide). Analysts are watching the FDA review closely given the magnitude of REDEFINE-1 results and the company's stated goal of repositioning CagriSema as a best-in-class option.