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Cagrilintide is an investigational weight-management drug developed by Novo Nordisk. It is a long-acting synthetic version (analog) of amylin, a hormone the pancreas releases together with insulin after meals. As of September 2026, cagrilintide is not FDA-approved, either on its own or as part of the combination product CagriSema.
Cagrilintide was modified with a fatty acid chain so that it lasts much longer in the body than natural amylin, which allowed once-weekly use in clinical trials.
Natural amylin helps signal fullness and slows how quickly the stomach empties. Cagrilintide is designed to act on the same amylin pathways over a much longer period. In CagriSema it is paired with semaglutide, a GLP-1 receptor agonist, so the combination acts on two different hormone systems involved in appetite.
Phase 2 (The Lancet, 2021): a 26-week trial in 906 adults with overweight or obesity and without diabetes compared five strengths of once-weekly cagrilintide with placebo and with liraglutide. Average weight loss with cagrilintide ranged from 6.0% to 10.8%, compared with 3.0% with placebo, assuming participants stayed on their assigned study drug.
Phase 3 REDEFINE 1 (New England Journal of Medicine, 2025): a 68-week trial in 3,417 adults without diabetes who had obesity, or overweight with at least one weight-related condition. Participants received CagriSema, semaglutide alone, cagrilintide alone or placebo, together with lifestyle support. Average weight change was -20.4% with CagriSema versus -3.0% with placebo. Gastrointestinal side effects such as nausea, vomiting, diarrhea, constipation and abdominal pain affected 79.6% of people on CagriSema and 39.9% on placebo, and were mostly mild to moderate and temporary.
REDEFINE 1 also included a cagrilintide-only group of 302 people. In September 2025, Novo Nordisk reported an average weight reduction of 11.8% in that group compared with 2.3% with placebo at 68 weeks.
Novo Nordisk then started a dedicated phase 3 program for cagrilintide on its own, called RENEW. According to ClinicalTrials.gov, RENEW 1 (adults with overweight or obesity) and RENEW 2 (adults with overweight or obesity and type 2 diabetes) began in November 2025.
Current status: Investigational – not FDA-approved.
Investigational means cagrilintide is being tested in clinical research but has not been approved by the FDA. It is not available as a prescription medicine in the United States.
Novo Nordisk submitted a New Drug Application to the FDA for CagriSema on December 18, 2025, and said it expected the FDA to complete its review during 2026. As of late September 2026, we found no announcement of an FDA decision. Even if CagriSema is approved, that approval would cover the combination product, not cagrilintide on its own, which is still in phase 3 trials.
Another amylin analog, pramlintide (Symlin), is FDA-approved for certain people with diabetes who use mealtime insulin. That approval does not apply to cagrilintide, which is a separate molecule.
Any product sold as cagrilintide outside a clinical trial, including products labeled "for research purposes only," is not an approved medicine, and the FDA has not reviewed its contents or quality.
Peptide Labs does not sell this compound. This page is general information, not medical advice. Our Peptide Guide exists to explain what these compounds are and how they are regulated, not to supply them.
Anyone with questions about cagrilintide should speak with a licensed healthcare provider, who can explain the current evidence and the legal status in plain terms.
See the full list of compound profiles in the Peptide Guide. See our profiles of CagriSema and semaglutide, or read our overview of peptides for weight loss.
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