CagriSema — EU research guide.

What is CagriSema?

CagriSema is a once-weekly subcutaneous co-formulation of two peptides: cagrilintide, a long-acting amylin analogue, and semaglutide, a GLP-1 receptor agonist. The rationale is mechanistic complementarity — amylin and GLP-1 act on partly different appetite and satiety pathways, so combining them is intended to produce greater weight loss than either alone. It is a fixed-dose combination (2.4 mg / 2.4 mg in the pivotal trials), not a single new molecule.

What does the research show?

In the Phase 3 REDEFINE 1 trial (adults with obesity, without diabetes), CagriSema produced a mean weight reduction of ~22.7% at 68 weeks under the "if all adhere" estimand, versus ~16.1% for semaglutide alone and ~11.8% for cagrilintide alone — confirming the combination outperforms its components. REDEFINE 2 (obesity with type 2 diabetes) showed ~15.7% weight loss. The results fell short of Novo Nordisk's internal 25% ambition but remain among the highest reported for an approved-mechanism obesity therapy. Novo Nordisk submitted CagriSema to the US FDA in December 2025; as of mid-2026 it is not yet approved.

EU legal status

Not yet approved in the EU. CagriSema is a proprietary fixed-dose combination owned by Novo Nordisk and under regulatory review. It is not a generic research peptide; gray-market material claiming to replicate the CagriSema combination cannot be assumed to match the clinical formulation or dosing.