{"id":"cagrilintide","name":"Cagrilintide","aliases":["CagriSema (with semaglutide)","amylin analogue","AM833"],"url":"https://lyoresearch.com/compounds/cagrilintide","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","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. 40.4% lost at least a quarter of body weight.","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":"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"}]}],"regions":[{"region":"European Union","status":"Not authorised — investigational","note":"Under development; no marketing authorisation."},{"region":"United States","status":"Not approved","note":"Phase 3 complete for CagriSema; filing and review pending."},{"region":"Canada","status":"Not authorised","note":"No Health Canada authorisation; not prescribable."}],"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"}