For research and educational purposes only. Not medical advice.

CagriSema Reference

Educational, not medical advice reference for CagriSema: GLP-1, Fat Loss; regulatory status, evidence posture, source review, and schedule notes…

Reference summary

REDEFINE-1 (Garvey 2025 NEJM, n=3,417 adults with obesity, 68 weeks) reported placebo-subtracted weight reductions consistent with a meaningful clinical effect; the primary 68-week mean weight change was greater for CagriSema than for semaglutide monotherapy or cagrilintide monotherapy alone, but the magnitude was smaller than the originally guided Novo Nordisk target prior to the readout. REDEFINE-2 (Davies 2025 NEJM) ran the same combination in adults with type 2 diabetes plus obesity. Adverse events were dose-dependent gastrointestinal (nausea, diarrhea, vomiting) consistent with both component classes; tolerability was the principal practical limitation versus monotherapy semaglutide.

Regulatory and posture

Categories
GLP-1, Fat Loss
Aliases
Cagrilintide + semaglutide fixed-dose combination, CagriSema 2.4 mg / 2.4 mg, Amylin analog (cagrilintide) + GLP-1 (semaglutide)
Evidence posture
human - REDEFINE-1 and REDEFINE-2 Phase 3 data exist and Novo Nordisk filed the FDA NDA in December 2025, but CagriSema remains investigational pending FDA review.
Regulatory status
Investigational fixed-dose combination of cagrilintide (long-acting amylin analog) and semaglutide. Novo Nordisk filed the FDA NDA in December 2025; not approved in the US or EU as of the data check date.
Content review status
investigational verified

Selected public sources

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