Overview
- The phase 3 REDEFINE 4 study failed its primary goal, as CagriSema produced less weight loss than tirzepatide after 84 weeks.
- On the efficacy estimand, average weight loss was 23.0% with CagriSema versus 25.5% with tirzepatide, and on the treatment‑regimen estimand it was 20.2% versus 23.6%.
- The open‑label trial enrolled 809 adults with obesity and at least one comorbidity; CagriSema’s safety profile was generally tolerable with mostly mild to moderate gastrointestinal events reported.
- Novo Nordisk shares fell roughly 15%–17% as Lilly gained about 3%–4%, with analysts saying the result reinforces Lilly’s market lead and complicates CagriSema’s commercial outlook.
- Novo said it expects an FDA decision on CagriSema by late 2026 and plans further studies, including a higher‑dose trial starting in the second half of 2026 and the REDEFINE 11 readout in the first half of 2027.