{"id":"cagrilintide","name":"Cagrilintide","aliases":["CagriSema (with semaglutide)","amylin analogue","AM833"],"url":"https://lyoresearch.com/compounds/cagrilintide","class":{"id":"glp-1-agonists","name":"GLP-1 and incretin agonists","url":"https://lyoresearch.com/classes/glp-1-agonists"},"summary":"Cagrilintide is a once-weekly analogue of amylin, a hormone the pancreas releases alongside insulin that signals fullness. On its own it produced about 12% weight loss over 68 weeks; combined with semaglutide as CagriSema it produced 22.7% in a 3,417-person phase 3 trial published in the New England Journal of Medicine. Neither is approved yet, and the combination missed the 25% figure its developer had signalled.","overall_grade":"B","overall_grade_meaning":"probable, not settled","human_trials":"Phase 3 published","regulatory_status":"Investigational","molecule":{"formula":"C194H312N54O59S2","molecular_weight":"4409","cas":"1415456-99-3","pubchem_cid":171397054,"note":null},"pharmacokinetics":{"basis":"human","route":"Subcutaneous, once weekly","half_life":"About 7–8 days (159–195 hours)","licensed_regimen":null,"product":null,"source":{"title":"Enebo LB, et al. Safety, tolerability, pharmacokinetics and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2.4 mg: a phase 1b trial. Lancet 2021","url":"https://www.sciencedirect.com/science/article/abs/pii/S014067362100845X"}},"outcomes":[{"outcome":"Body weight (with semaglutide, CagriSema)","grade":"B","grade_meaning":"probable, not settled","effect_size":"large","adverse":false,"human_studies":"1 large phase 3 RCT","evidence":"REDEFINE 1: −22.7% at 68 weeks in 3,417 adults vs −16.1% semaglutide alone, −11.8% cagrilintide alone, −2.3% placebo (trial-product estimand, i.e. while on treatment). The abstract's intention-to-treat figure is −20.4% vs −3.0%. 40.4% lost at least a quarter of body weight. The combination has its own page.","references":[{"citation":"Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1).","where":"N Engl J Med, 2025; DOI 10.1056/NEJMoa2502081","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2502081"}],"verbatim":{"text":"The estimated mean percent change in body weight from baseline to week 68 was -20.4% with cagrilintide-semaglutide as compared with -3.0% with placebo (estimated difference, -17.3 percentage points; 95% confidence interval, -18.1 to -16.6; P<0.001).","citation":"Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1).","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2502081"}},{"outcome":"Body weight (alone)","grade":"B","grade_meaning":"probable, not settled","effect_size":"moderate","adverse":false,"human_studies":"Phase 2 + phase 3 arm","evidence":"−11.8% at 68 weeks as monotherapy in REDEFINE 1 — meaningful, but below the incretin drugs.","references":[{"citation":"Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1).","where":"N Engl J Med, 2025; DOI 10.1056/NEJMoa2502081","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2502081"}]},{"outcome":"GI side effects","grade":"B","grade_meaning":"probable, not settled","effect_size":"moderate","adverse":true,"human_studies":"Phase 3","evidence":"Mostly mild-to-moderate nausea and vomiting, easing over time; the profile reported as consistent with GLP-1 drugs.","references":[{"citation":"Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1).","where":"N Engl J Med, 2025; DOI 10.1056/NEJMoa2502081","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2502081"}],"verbatim":{"text":"Gastrointestinal adverse events (affecting 79.6% in the cagrilintide-semaglutide group and 39.9% in the placebo group), including nausea, vomiting, diarrhea, constipation, or abdominal pain, were mainly transient and mild-to-moderate in severity.","citation":"Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1).","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2502081"}}],"regions":[{"region":"European Union","status":"Investigational; not authorised","note":"In phase 3 (with semaglutide as CagriSema). No authorisation; supply outside trials is unlawful."},{"region":"United States","status":"Investigational; cannot be compounded","note":"FDA: cagrilintide 'cannot be used in compounding under federal law'. Not a component of any approved drug."},{"region":"United Kingdom","status":"Unlicensed","note":"Investigational; supply outside trials is an offence."},{"region":"Australia","status":"Unapproved","note":"Not on the ARTG; prescription-only substance with no lawful supply outside trials."},{"region":"Canada","status":"Not authorised","note":"Investigational; no DIN."},{"region":"Sport (WADA)","status":"Prohibited at all times","note":"Unapproved anywhere, so it falls under S0 (non-approved substances)."}],"faq":[{"q":"Is CagriSema better than semaglutide?","a":"In REDEFINE 1, yes: 22.7% versus 16.1% at 68 weeks in the same trial. It fell short of the 25% figure the market had expected, which is why the result was reported as a disappointment despite being the larger number."},{"q":"What is amylin?","a":"A hormone released with insulin after eating that signals fullness and slows stomach emptying. Cagrilintide is a version engineered to last about a week."},{"q":"Can you buy cagrilintide?","a":"Not legally. It is investigational; anything sold under the name is unlicensed and of unknown content."}],"references":[{"cite":"Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1).","where":"N Engl J Med, 2025; DOI 10.1056/NEJMoa2502081","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2502081","note":"3,417 adults, 68 weeks, four arms."}],"last_reviewed":"2026-09-02","literature_searched_to":"2026-09-02","changelog":[{"date":"2026-09-02","note":"Initial publication from the published REDEFINE 1 trial."}],"license":"CC BY 4.0 — cite as “LYO Research” with a link.","methodology":"https://lyoresearch.com/methodology"}