Novo Nordisk Seeks FDA Approval for CagriSema, a Weekly Obesity Treatment
- Novo Nordisk submitted a New Drug Application for CagriSema to the FDA on December 18, 2025.
- CagriSema combines cagrilintide and semaglutide for obesity management.
- The REDEFINE 1 trial showed a 23% average weight loss for patients on CagriSema.
- FDA review of CagriSema is expected in 2026.
FDA Submission
Novo Nordisk has submitted a New Drug Application to the U.S. FDA for CagriSema, a once-weekly injectable treatment combining cagrilintide and semaglutide, aimed at managing obesity and overweight conditions.
Clinical Trial Results
The REDEFINE 1 phase 3 trial demonstrated that adults with obesity or overweight, taking CagriSema, experienced an average weight loss of 23% when all patients stayed on treatment. The trial involved 3,417 adults and compared CagriSema to semaglutide alone, cagrilintide alone, and placebo.
Safety and Efficacy
Safety data from the REDEFINE 1 and 2 trials showed that CagriSema had a tolerability profile consistent with the GLP-1 receptor agonist class. Adverse events were mainly gastrointestinal, with low discontinuation rates due to adverse events.
Future Outlook
If approved, CagriSema would be the first injectable combination of a GLP-1 receptor agonist and an amylin analogue for obesity treatment. The FDA is expected to review the application in 2026.
Source: Novo Nordisk