Novo’s CagriSema linked to ~25% weight loss in women in REDEFINE 1 post hoc analyses
- CagriSema 2.4 mg/2.4 mg was associated with mean weight loss of 25.0% at week 68 versus 3.0% with placebo in 2,309 women (efficacy estimand).
- By menopausal stage, mean weight loss at week 68 with CagriSema was 26.7% (premenopausal), 24.8% (perimenopausal) and 23.1% (postmenopausal), versus ~2% with placebo.
- CagriSema reduced waist circumference by an estimated 20.5 cm versus 4.7 cm with placebo, and 68.7% of treated women achieved ≥20% bodyweight loss.
- Discontinuation for adverse events was 5.9% with CagriSema versus 3.5% for placebo; adverse events were mainly gastrointestinal (nausea 55%, constipation 30.7%, vomiting 26.1%).
Key findings from REDEFINE 1 post hoc analyses
Two post hoc analyses of the 68‑week REDEFINE 1 phase 3 trial showed once‑weekly CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg) was associated with a mean weight loss of 25.0% at week 68 in 2,309 women (efficacy estimand) versus 3.0% with placebo, along with an estimated mean waist‑circumference reduction of 20.5 cm versus 4.7 cm. Achievement of major weight‑loss thresholds was notable (68.7% reached ≥20% loss). Exploratory analyses are hypothesis‑generating and warrant further study.
Analysis by menopausal stage
A separate post hoc grouping of 1,902 women by menopausal status (derived from age, history and symptoms) found clinically meaningful weight loss across stages: 26.7% in premenopausal, 24.8% in perimenopausal and 23.1% in postmenopausal women at week 68, compared with approximately 2% weight change with placebo. Menopause classification was not prospectively staged or biochemically confirmed.
Safety
Discontinuations due to adverse events occurred in 5.9% of CagriSema recipients versus 3.5% with placebo. Adverse events were predominantly gastrointestinal and mostly transient and mild‑to‑moderate in severity, including nausea (55% vs 12.6%), constipation (30.7% vs 11.6%) and vomiting (26.1% vs 4.1%).
Regulatory status
Novo filed a New Drug Application for CagriSema for weight management in December 2025; a U.S. FDA decision was expected in Q4 2026. CagriSema is investigational and not approved in the United States; safety and efficacy are not established.
Source: Novo Nordisk