Novo reports 21% weight loss with lower-dose CagriSema in phase 3 trial
- At week 68, estimated average weight loss was 20.7% with CagriSema 1.7 mg/1.7 mg and 21.0% with 1.0 mg/1.0 mg, versus 2.0% with placebo under the efficacy estimand.
- Under the treatment-regimen estimand, average weight loss was 19.4% and 18.6% at the respective doses, versus 4.6% with placebo.
- CagriSema combines cagrilintide, a long-acting amylin analog, with the GLP-1 receptor agonist semaglutide.
- Novo filed for FDA approval of CagriSema 2.4 mg/2.4 mg in December 2025; a decision was expected in Q4 2026.
Trial results
In the 68-week phase 3 REDEFINE 9 trial, 309 adults with obesity or overweight and an obesity-related complication, without diabetes, received once-weekly CagriSema or placebo alongside lifestyle intervention. Under the efficacy estimand, which assumes participants remained on treatment, average weight loss was 20.7% with CagriSema 1.7 mg/1.7 mg and 21.0% with 1.0 mg/1.0 mg, compared with 2.0% with placebo. The trial was not designed to compare the two CagriSema doses directly.
Under the treatment-regimen estimand, which accounts for treatment discontinuation or use of rescue intervention, average weight loss was 19.4% and 18.6% at the respective doses, versus 4.6% with placebo. Waist circumference fell by 17.2 cm and 17.5 cm, respectively, compared with 3.6 cm with placebo.
Safety and regulatory status
The safety profile at both doses was consistent with previous CagriSema trials. The most frequently reported adverse events were gastrointestinal and mild to moderate. Permanent discontinuation due to adverse events occurred in 2.9% of participants on the 1.7 mg/1.7 mg dose and 4.9% on the 1.0 mg/1.0 mg dose, compared with 4.9% on placebo.
Novo filed a New Drug Application with the U.S. FDA in December 2025 for CagriSema 2.4 mg/2.4 mg for weight management. An FDA decision was expected in Q4 2026. CagriSema remains investigational and is not approved for use in the United States.
Source: Novo Nordisk