The REDEFINE Trials: CagriSema's Clinical Evidence
TRIAL-000004
Part of the DietApp.com GLP-1 Trial Database, a comprehensive, regularly reviewed resource.
What It Is
REDEFINE is the Phase 3 clinical trial program for CagriSema, Novo Nordisk's investigational fixed-dose combination of cagrilintide and semaglutide, being studied for chronic weight management. A related program, REIMAGINE, studies CagriSema specifically in adults with type 2 diabetes.
Key Results
REDEFINE 1 enrolled 3,417 adult participants without diabetes, with obesity or overweight and at least one weight-related complication, over 68 weeks. Results showed CagriSema produced greater weight loss than either component alone, with figures reported up to 22.7% under some analyses, compared to roughly 13.7 to 16.1% for semaglutide alone and roughly 11.5 to 11.8% for cagrilintide alone in the same trial.
What This Means for Approval Status
CagriSema is not yet FDA-approved. Novo Nordisk submitted a New Drug Application based on REDEFINE 1 data in December 2025, and FDA review is expected during 2026. Until approved, CagriSema remains accessible only through clinical trial enrollment, discussed in more detail on our Cagrilintide page.
A Side Effect Worth Noting
REDEFINE trial data showed injection-site reactions were notably more common with cagrilintide-containing treatment than with semaglutide alone, roughly 12% with CagriSema and 17% with cagrilintide alone, compared to about 2.6% with semaglutide alone, a genuine tolerability difference worth knowing about this specific combination.
References
- Novo Nordisk: CagriSema NDA Submission Announcement (December 2025)
- Drugs.com: CagriSema Approval Status
- BioSpace: Novo Nordisk Files CagriSema for FDA Approval
Related Resources
Related Articles
- The STEP Trials
- The SURMOUNT Trials
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Last medically reviewed and updated: July 11, 2026.
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