Cagrilintide
Novo Nordisk
Cagrilintide is a stable, lipidated, long-acting analogue of amylin, a pancreatic hormone that induces satiety. The older amylin analogue pramlintide needs injecting three times a day because of its short half-life; cagrilintide was designed for once-weekly dosing. Structural studies show it activates both amylin receptors and the calcitonin receptor. As monotherapy, a 26-week phase 2 dose-finding trial (Lau et al., Lancet 2021) found mean weight reductions of 6.0–10.8% across doses of 0.3–4.5 mg weekly, versus 3.0% with placebo. The 4.5 mg dose (10.8%) beat liraglutide 3.0 mg (9.0%). The main clinical programme combines cagrilintide 2.4 mg with semaglutide 2.4 mg as CagriSema. In the phase 3 REDEFINE 1 trial (adults with overweight or obesity, no diabetes), mean body-weight change at 68 weeks was −20.4% with CagriSema versus −3.0% with placebo. In REDEFINE 2 (adults with obesity and type 2 diabetes) it was −13.7% versus −3.4%. Gastrointestinal adverse events were common: 79.6% versus 39.9% with placebo in REDEFINE 1. They were mainly transient and mild to moderate. Cagrilintide is not FDA-approved. The FDA has issued warning letters treating cagrilintide sold online as an unapproved new drug.
Specifications
| Origin / Manufacturer | Synthetic (amylin analog) |
| Active Components | Cagrilintide |
| Storage | 2–8°C; do not freeze |
| Form Factor | Pre-filled pen (solution for injection) |
Clinical Evidence
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Frequently Asked Questions
Sources & References
Every clinical claim on this page traces to a primary peer-reviewed source.
- 1Lau DCW, Erichsen L, Francisco AM, et al.. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet (London, England). 2021;398(10317):2160-2172. doi:10.1016/S0140-6736(21)01751-7 PMID:34798060
- 2Frias JP, Deenadayalan S, Erichsen L, et al.. Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial. Lancet (London, England). 2023;402(10403):720-730. doi:10.1016/S0140-6736(23)01163-7 PMID:37364590
- 3Enebo LB, Berthelsen KK, Kankam M, et al.. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2·4 mg for weight management: a randomised, controlled, phase 1b trial. Lancet (London, England). 2021;397(10286):1736-1748. doi:10.1016/S0140-6736(21)00845-X PMID:33894838
- 4Garvey WT, Blüher M, Osorto Contreras CK, et al.. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. The New England journal of medicine. 2025;393(7):635-647. doi:10.1056/NEJMoa2502081 PMID:40544433
- 5Davies MJ, Bajaj HS, Broholm C, et al.. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. The New England journal of medicine. 2025;393(7):648-659. doi:10.1056/NEJMoa2502082 PMID:40544432
- 6Buse JB, Bajaj HS, Dalskov SM, et al.. Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study. The lancet. Diabetes & endocrinology. 2026;14(8):662-677. doi:10.1016/S2213-8587(26)00125-7 PMID:42251859
- 7Kruse T, Hansen JL, Dahl K, et al.. Development of Cagrilintide, a Long-Acting Amylin Analogue. Journal of medicinal chemistry. 2021;64(15):11183-11194. doi:10.1021/acs.jmedchem.1c00565 PMID:34288673
- 8Gu YM, Yuan QN, Li X, et al.. Structural and mechanistic insights into dual activation of cagrilintide in amylin and calcitonin receptors. Acta pharmacologica Sinica. 2026;47(1):162-172. doi:10.1038/s41401-025-01635-2 PMID:40847076
- 9U.S. Food and Drug Administration. Warning Letter: Summit Research Peptides (MARCS-CMS 695607). FDA Warning Letters. 2024.
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Endocrinology & Obesity Medicine Review
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