Novo Nordisk CagriSema trial data show weight loss in women by menopause stage
Novo Nordisk (NYSE: NVO) presented results from two post hoc analyses of its REDEFINE 1 trial at The Menopause Society 2026 Annual Meeting in San Diego, examining the investigational drug CagriSema across women with obesity or overweight.
In the first analysis of 2,309 women, CagriSema 2.4 mg / 2.4 mg was associated with an average weight loss of 25.0% at week 68 under an efficacy estimand, compared with 3.0% for placebo. The combination also showed a reduction in waist circumference of 20.5 cm versus 4.7 cm with placebo. Among CagriSema-treated participants, 93.3% achieved at least 10% body weight loss and 68.7% achieved at least 20%, compared with 12.7% and 1.8% with placebo, respectively.
In a second analysis of 1,902 women grouped by menopausal status, average weight loss at week 68 was 26.7% in premenopausal women, 24.8% in perimenopausal women and 23.1% in postmenopausal women, compared with approximately 2% across all placebo groups. Menopausal status was derived post hoc using age, medical history and recorded symptoms, and was not based on prospectively collected reproductive staging or biochemical confirmation.

Discontinuation due to adverse events occurred in 5.9% of CagriSema participants versus 3.5% with placebo in the broader REDEFINE 1 trial. Gastrointestinal adverse events were reported in 79.6% of the CagriSema group compared with 39.9% with placebo, including nausea, constipation and vomiting, which were described as mostly transient and mild-to-moderate in severity.
Novo Nordisk filed a New Drug Application with the U.S. Food and Drug Administration in December 2025 for CagriSema for weight management, with a regulatory decision expected in the fourth quarter of 2026. CagriSema is not currently approved in the United States, and its safety and efficacy have not been established. The company noted that exploratory post hoc analyses are hypothesis-generating and that further research is needed.

