CagriSema (cagrilintide + semaglutide)

CagriSema is a fixed-dose co-formulation of cagrilintide (a long-acting amylin analog) and semaglutide (a GLP-1 receptor agonist), developed by Novo Nordisk. It targets two complementary gut-hormone pathways: amylin slows gastric emptying and reduces glucagon, while GLP-1 increases insulin secretion and reduces appetite.

The REIMAGINE 2 trial (February 2026) showed HbA1c reduction up to 1.91 points and 14.2% weight loss in type 2 diabetes. In the open-label head-to-head REDEFINE 4 (February 2026), CagriSema produced 23% weight loss at 84 weeks but failed to show non-inferiority versus tirzepatide 15 mg, a significant competitive setback.

Novo Nordisk filed CagriSema with the FDA for weight loss in late 2025. The filing is under review as of August 2026. The combination of two approved drug classes (amylin + GLP-1) in a single injection is pharmacologically sound, unlike most peptide stacks which combine unapproved research chemicals.

The key differentiator versus standalone GLP-1 therapy is the amylin component, which adds satiety signaling through a different receptor pathway. However, the failure to beat tirzepatide in head-to-head comparison limits the clinical case for switching from an approved triple agonist to a dual.

CagriSema is not yet FDA-approved. Both components are prescription drugs, not research chemicals. Cagrilintide alone (without semaglutide) is also in development but has not been approved as a standalone product.