Short summary: CagriSema is an investigational weekly injection that combines cagrilintide with semaglutide. Phase 3 trials reported greater weight loss than placebo or either component alone, but it should not be treated as an available medication unless regulators approve it.
Key takeaways
- CagriSema combines semaglutide, a GLP-1 receptor agonist, with cagrilintide, a long-acting amylin analogue.
- REDEFINE 1 and REDEFINE 2 were phase 3 trials in adults with overweight or obesity, with and without type 2 diabetes.
- The combination is not the same as mixing separate products, and it needs regulatory review, approved labeling, and clinician oversight.
What CagriSema is
CagriSema is a fixed-dose combination of cagrilintide and semaglutide given once weekly in clinical trials. Semaglutide is the GLP-1 medicine used in products such as Ozempic and Wegovy. Cagrilintide is an investigational long-acting amylin analogue. Amylin is a hormone involved in satiety and post-meal glucose regulation.
The reason researchers are interested in the combination is that the two components act through different appetite and metabolic pathways. In theory, that can increase weight-loss effects. Trial data are needed because theory does not prove real-world benefit or safety.
What the REDEFINE trials found
The American College of Cardiology summarized two phase 3a trials published in The New England Journal of Medicine in June 2025. REDEFINE 1 enrolled adults with overweight or obesity without type 2 diabetes. REDEFINE 2 enrolled adults with overweight or obesity and type 2 diabetes.
In REDEFINE 1, the estimated average weight reduction at 68 weeks was larger with CagriSema than with placebo, semaglutide alone, or cagrilintide alone. In REDEFINE 2, adults with type 2 diabetes also lost more weight with CagriSema than placebo, and more participants reached an A1C at or below 6.5% compared with placebo.
These results are promising, but they come from trials with eligibility criteria, dose titration, monitoring, and lifestyle intervention. Trial results do not mean every person will respond the same way.
Safety and approval caveats
Gastrointestinal side effects were more common with CagriSema than placebo in the ACC summary. That fits with the broader GLP-1 class experience, where nausea, vomiting, constipation, diarrhea, and reduced appetite can occur. Any future label would need to explain approved dosing, contraindications, warnings, and monitoring.
Company-reported regulatory status as of May 23, 2026: Novo Nordisk announced in December 2025 that it submitted a New Drug Application to the FDA for CagriSema for chronic weight management. The company announcement stated that CagriSema was not approved in the United States or European Union at that time. Novo Nordisk’s Q1 2026 investor presentation listed an expected U.S. decision in the fourth quarter of 2026. That is a company-reported timeline, not proof of FDA approval and not a guaranteed decision date. Readers should treat CagriSema as investigational unless an approved regulatory label becomes available.
For related background, read our diabetes medications guide, our Mounjaro guide, and our article on managing GLP-1 side effects.
Practical takeaway
CagriSema is a medication to watch, not a do-it-yourself treatment. Avoid online or compounded products claiming to be CagriSema. If you are considering obesity or diabetes medication, use approved products and discuss benefits, risks, cost, side effects, and monitoring with a licensed clinician.
Sources
- American College of Cardiology: REDEFINE 1 and REDEFINE 2 summary
- New England Journal of Medicine: REDEFINE 2 abstract
- Novo Nordisk: FDA filing announcement for CagriSema
- Novo Nordisk: Q1 2026 investor presentation
Editorial review note: reviewed for medical accuracy, source consistency, patient-safety framing, regulatory-status wording, and plain-language readability before publication.