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CagriSema
GLP-1 Analogs

CagriSema

Novo Nordisk

CagriSema is a once-weekly subcutaneous injection that combines cagrilintide, a long-acting amylin analogue, with semaglutide, a GLP-1 receptor agonist that is already approved on its own. Amylin and GLP-1 reduce food intake through partly different pathways, so the combination is meant to give more weight loss than either drug alone. Evidence: in the phase 3a REDEFINE 1 trial (3,417 adults with overweight or obesity, no diabetes, 68 weeks), mean weight change was -20.4% with CagriSema versus -3.0% with placebo. In REDEFINE 2 (1,206 adults with obesity and type 2 diabetes), it was -13.7% versus -3.4%, and 73.5% reached an HbA1c of 6.5% or less. In REDEFINE 5 in Japan and Taiwan, CagriSema beat semaglutide 2.4 mg alone (-18.4% versus -11.9%). Gastrointestinal adverse events affected about 73–80% of participants on CagriSema in REDEFINE 1 and 2, mostly transient and mild to moderate. Regulatory status: as of this update there is no FDA approval (no Drugs@FDA record). CagriSema is investigational and is only available in clinical trials; products sold online under this name are not the investigational medicine. Approved options such as semaglutide and tirzepatide remain the standard of care.

Specifications

Origin / ManufacturerFixed-dose combination of two synthetic peptides
Active Components
Cagrilintide (amylin analog)Semaglutide (GLP-1 receptor agonist)
StorageNot established in public labeling (investigational)
Shelf LifeNot established (investigational)
Form FactorSubcutaneous injection, once weekly (fixed-dose combination)

Clinical Evidence

Phase 1b (n=95, 20 weeks): cagrilintide 0.16–4.5 mg with semaglutide 2.4 mg was well tolerated; cagrilintide did not affect semaglutide exposure; half-lives were 159–195 h (cagrilintide) and 145–165 h (semaglutide).

Clinical report reference

Phase 2 (type 2 diabetes, n=92, 32 weeks): HbA1c -2.2 points with CagriSema versus -1.8 with semaglutide (difference not significant) and -0.9 with cagrilintide; body weight -15.6% versus -5.1% and -8.1%.

Clinical report reference

REDEFINE 1 (phase 3a, n=3,417, no diabetes, 68 weeks): -20.4% with CagriSema versus -3.0% with placebo; gastrointestinal events in 79.6% versus 39.9%, mostly transient and mild to moderate.

Clinical report reference

REDEFINE 2 (phase 3a, n=1,206, type 2 diabetes, 68 weeks): -13.7% versus -3.4% with placebo; 73.5% reached HbA1c ≤6.5% versus 15.9%.

Clinical report reference

REDEFINE 5 (phase 3a, Japan and Taiwan, n=331, 68 weeks): -18.4% with CagriSema versus -11.9% with semaglutide 2.4 mg alone.

Clinical report reference

Regulatory: not FDA-approved as of October 2026 (no Drugs@FDA record).

Clinical report reference

Frequently Asked Questions

Sources & References

Every clinical claim on this page traces to a primary peer-reviewed source.

  1. 1Enebo 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. 2021;397(10286):1736-1748. doi:10.1016/S0140-6736(21)00845-X PMID:33894838
  2. 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. 2023;402(10403):720-730. doi:10.1016/S0140-6736(23)01163-7 PMID:37364590
  3. 3Garvey WT, Blüher M, Osorto Contreras CK, et al.. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine. 2025;393(7):635-647. doi:10.1056/NEJMoa2502081 PMID:40544433
  4. 4Davies MJ, Bajaj HS, Broholm C, et al.. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. New England Journal of Medicine. 2025;393(7):648-659. doi:10.1056/NEJMoa2502082 PMID:40544432
  5. 5Yamauchi T, Becker NP, Hagemann CA, et al.. Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity with or without type 2 diabetes in Japan and Taiwan (REDEFINE 5): a multicentre, randomised, active-controlled, phase 3a trial. Lancet Diabetes & Endocrinology. 2026;14(6):450-462. doi:10.1016/S2213-8587(25)00402-4 PMID:42009015

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