Novo Nordisk reported positive topline results for low-dose CagriSema, its experimental combination of cagrilintide and semaglutide, as the drug remains under U.S. regulatory review.
In the phase 3 REIMAGINE 5 trial involving people with type 2 diabetes, the 1.0 mg/1.0 mg CagriSema dose produced an estimated average weight loss of 12.4% after 60 weeks, versus 9.1% for Eli Lilly’s 5 mg tirzepatide dose.
CagriSema also reduced HbA1c by 1.71%, compared with 1.67% for tirzepatide, meeting the study’s non-inferiority criterion.
In the REDEFINE 9 obesity trial, the same low dose delivered 21.0% average weight loss after 68 weeks, compared with 2.0% for placebo.
The results are strategically important for Novo because earlier CagriSema data had disappointed investors and the company is competing directly with Lilly’s Mounjaro and Zepbound franchises.
Novo filed for FDA approval for weight management in December 2025. A U.S. decision is expected in the fourth quarter of 2026, but CagriSema is not yet approved.
Sources:
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