Novo Nordisk reports strong weight‑loss results for investigational CagriSema in Phase 3 REDEFINE 9 trial
Novo Nordisk presented data from the 68‑week Phase 3 REDEFINE 9 study, showing that adults receiving CagriSema lost roughly 21% of body weight, far exceeding the modest loss seen with placebo. The trial evaluated two lower doses of the fixed‑dose amylin‑GLP‑1 combination, 1.7 mg/1.7 mg and 1.0 mg/1.0 mg, in 309 participants with overweight or obesity. Both doses produced statistically significant weight reductions and higher rates of ≥5% loss compared with placebo. The company filed an NDA for the 2.4 mg/2.4 mg formulation in December 2025, with an FDA decision expected in Q4 2026.
Why it matters
The company says the results support the potential of CagriSema as a new obesity therapy, which could expand Novo's product pipeline and drive future revenue if approved. Analysts note that the strong efficacy may improve market expectations for the upcoming FDA decision.
Key facts
- 1In the REDEFINE 9 trial, 309 adults with overweight or obesity were randomized to CagriSema 1.7 mg/1.7 mg, CagriSema 1.0 mg/1.0 mg, or placebo. finance.yahoo.com
- 2Based on the treatment‑regimen estimand, average weight loss at week 68 was 19.4% for the 1.7 mg/1.7 mg dose and 18.6% for the 1.0 mg/1.0 mg dose, versus 4.6% with placebo. finance.yahoo.com
- 3Using a different analysis, the estimated average weight loss was 20.7% for the 1.7 mg/1.7 mg dose and 21.0% for the 1.0 mg/1.0 mg dose, versus 2.0% with placebo. rttnews.com
- 4At week 68, 92.8% of participants on the 1.7 mg/1.7 mg dose and 87.7% on the 1.0 mg/1.0 mg dose achieved at least a 5% body‑weight reduction, compared with 41.1% on placebo. finance.yahoo.com
- 5Novo filed a New Drug Application with the FDA in December 2025 for CagriSema 2.4 mg/2.4 mg, with a decision expected in Q4 2026. finance.yahoo.com
- 6Novo's shares closed at $41.63, up $0.98 or 2.41% on the day the results were announced. rttnews.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.