Novo Nordisk's fixed-dose combination of cagrilintide and semaglutide — targeting dual amylin/GLP-1 pathways for maximum weight loss.
CagriSema is a fixed-dose, once-weekly subcutaneous injection combining cagrilintide (a long-acting amylin analog) with semaglutide (a GLP-1 receptor agonist) in a single prefilled pen. Developed by Novo Nordisk, it represents the company's strategy to maintain leadership in the obesity market by combining two complementary metabolic pathways.
The rationale is mechanistic synergy: semaglutide activates GLP-1 receptors for appetite suppression and insulin sensitization, while cagrilintide activates amylin receptors for additional satiety, gastric emptying reduction, and glucagon suppression. The combination targets weight loss from multiple angles simultaneously.
CagriSema is being developed specifically to compete with — and potentially surpass — Eli Lilly's tirzepatide (Zepbound). Phase 3 trials are comparing CagriSema directly to tirzepatide in head-to-head studies, and results will determine its competitive positioning.
Phase 2 results showed CagriSema achieved approximately 15.6% weight loss over 32 weeks — competitive with semaglutide alone but in a shorter timeframe. Phase 3 REDEFINE trials at higher doses (including cagrilintide 2.4 mg + semaglutide 2.4 mg) are expected to show greater weight loss.
The REDEFINE-1 trial (CagriSema vs. placebo) and REDEFINE-2 (CagriSema vs. tirzepatide) are the pivotal Phase 3 studies. Results are anticipated in 2025-2026 and will be critical for FDA filing and market positioning.
📚 Key Reference: PMID: 37783237 (CagriSema Phase 2)
GI side effects from both GLP-1 and amylin pathways — nausea may be more prominent than either agent alone. Thyroid C-cell tumor warnings apply (from semaglutide component). Full safety profile pending Phase 3. Clinical trial use only.
NOT FDA-approved. In Phase 3 clinical trials. Not available outside clinical trials.