- CagriSema achieved 23% weight loss in 84 weeks but didn't meet the primary endpoint against tirzepatide.
- The trial involved 809 participants with obesity and comorbidities.
- CagriSema was submitted to the US FDA in December 2025, with a decision expected by late 2026.
- A higher-dose CagriSema trial is planned for the second half of 2026.
Trial Overview
Novo Nordisk's REDEFINE 4 trial investigated CagriSema, a combination of cagrilintide and semaglutide, over 84 weeks in 809 participants with obesity and comorbidities. The trial compared CagriSema to tirzepatide, both administered weekly.
Results
CagriSema achieved a 23% weight loss, but did not meet the primary endpoint of non-inferiority to tirzepatide, which showed a 25.5% weight loss. The treatment-regimen estimand showed CagriSema at 20.2% versus tirzepatide at 23.6%.
Safety Profile
CagriSema was generally safe and well-tolerated, with mild to moderate gastrointestinal side effects that diminished over time, consistent with GLP-1 receptor agonists.
Future Plans
CagriSema was submitted to the US FDA in December 2025, with a decision expected by late 2026. A higher-dose CagriSema trial is planned for the second half of 2026, and the REDEFINE 11 trial will report data in the first half of 2027.
