Novo Nordisk announced results from two post hoc analyses of its phase 3 REDEFINE 1 trial on Tuesday, showing its investigational drug CagriSema was associated with average weight loss of 25.0% among women. The company presented the analyses at The Menopause Society 2026 Annual Meeting in San Diego.
The first analysis covered 2,309 women with obesity or overweight. At week 68, women on CagriSema 2.4 mg / 2.4 mg lost 25.0% of their bodyweight on average, compared with 3.0% for women on placebo. Novo said the figures use the efficacy estimand, which projects outcomes under a best-case setup where every participant kept taking the drug and used no other weight loss treatments.
A second analysis covering 1,902 women, split into groups by stage of menopause, showed average losses of 26.7% for premenopausal participants, 24.8% for perimenopausal participants and 23.1% for those who were postmenopausal. Placebo groups lost 2.1%, 1.7% and 2.6%, respectively.
Waist circumference, a measure associated with abdominal fat, fell by 20.5 cm on average among women on CagriSema, compared with 4.7 cm on placebo, Novo said.
The company said the p-values were not adjusted for multiplicity and that formal testing of differences by sex or subgroup was not performed. Menopause status was assigned after the fact using age, medical history and recorded symptoms, not prospectively collected staging or biochemical confirmation. Novo described the analyses as hypothesis-generating.
"Many women with obesity or overweight experience weight gain as they move through menopause, and it is important to explore investigational products such as CagriSema across the reproductive lifespan," Michelle Skinner Moore, Novo's interim head of clinical development, medical and regulatory affairs, said in a statement.
Maria D. Hurtado Andrade, an assistant professor at Mayo Clinic Alix School of Medicine and lead author of the analyses, said the numerical differences among the groups point to a need for more research on how reproductive aging may influence weight loss.
Early readouts from the full trial indicated that adults shed 22.7% of their body weight over 68 weeks on average, against 2.3% for placebo, according to CNBC. About two-thirds of the roughly 3,400 participants were women.
In REDEFINE 1, 5.9% of participants on CagriSema stopped treatment because of adverse events, compared with 3.5% on placebo. Gastrointestinal events occurred in 79.6% of the CagriSema group and 39.9% of the placebo group, including nausea, constipation and vomiting. Novo said the events were mostly transient and mild to moderate.
CagriSema is a once-weekly combination of semaglutide and cagrilintide, an amylin analog. Novo filed a New Drug Application with the U.S. Food and Drug Administration in December 2025, and a decision is expected in the fourth quarter of 2026. The drug is not approved in the United States.