CagriSema linked to 25% average weight loss in women in REDEFINE 1 analysis
Two post hoc analyses of the REDEFINE 1 trial link the investigational drug CagriSema to 25.0% average weight loss at 68 weeks in 2,309 women, with smaller losses among postmenopausal women.
Two post hoc analyses of the Phase 3 REDEFINE 1 trial link CagriSema, an investigational once-weekly injection, to an average 25.0% weight loss at 68 weeks in 2,309 women with obesity or overweight, compared with 3.0% for placebo [1][2]. The results were presented October 20, 2026, at The Menopause Society annual meeting in San Diego [1][3].
CagriSema is a fixed-dose combination of cagrilintide 2.4 mg, a long-acting amylin analog, and semaglutide 2.4 mg, a GLP-1 receptor agonist [1]. Semaglutide is the active ingredient in Ozempic, Wegovy and Rybelsus; CagriSema is a separate product and is not approved for use in the United States [1].
The 25.0% figure comes from an analysis of all women enrolled in REDEFINE 1. It uses the efficacy estimand, an idealized scenario in which every patient stayed on treatment and took no other weight-loss therapies [1]. Within the same analysis, women on semaglutide 2.4 mg alone lost an average 19.0% and those on cagrilintide alone lost 13.4%, against 3.0% for placebo [1]. Average waist circumference fell 20.5 cm with CagriSema versus 4.7 cm with placebo [1]. About 93.3% of women on CagriSema lost at least 10% of body weight, and 68.7% lost at least 20%, compared with 12.7% and 1.8% on placebo [1]. Mean starting weight in the CagriSema group was 101.5 kg [1].
A second analysis grouped 1,902 women 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 2.1%, 1.7% and 2.6% with placebo [1]. Novo said menopausal status was assigned after the fact using age, medical history and recorded symptoms, not through prospectively collected reproductive staging or blood tests [1]. The company also said the p-values were not adjusted for multiple comparisons and that no formal statistical testing of differences between menopausal groups was performed, so the gap between the groups may not reflect a real effect of reproductive stage [1].
"The weight loss observed in each group is encouraging, and the numerical differences among the groups highlight the need for further research to better understand how reproductive aging may influence weight loss outcomes in women," said Maria D. Hurtado Andrade, M.D., Ph.D., of Mayo Clinic Alix School of Medicine, lead author of the analyses [1]. Novo described both analyses as hypothesis-generating and said further study is needed [1][2].
In the full REDEFINE 1 trial of 3,417 adults, CagriSema produced 22.7% average weight loss versus 2.3% with placebo [1][3]. Reuters reported that the 22.7% result fell below the 25% Novo had targeted [2].
Why it matters for patients
CagriSema is not available by prescription, and the numbers above describe averages in a research setting, not what any one person would experience [1]. The efficacy-estimand approach assumes no one stopped treatment; in the trial, 5.9% of participants on CagriSema stopped because of adverse events versus 3.5% on placebo [1]. Gastrointestinal side effects were reported by 79.6% of those on CagriSema versus 39.9% on placebo, including nausea (55% vs 12.6%), constipation (30.7% vs 11.6%) and vomiting (26.1% vs 4.1%), and were mostly transient and mild to moderate [1]. Those safety figures cover the whole trial population, not women only [1].
Because the menopausal-stage comparison was not set up in advance, it does not show that postmenopausal women respond worse to the drug; that question has not been answered [1]. Novo said CagriSema has the potential to be the first amylin analog and GLP-1 receptor agonist combination for weight management [1].
What happens next
Novo filed a New Drug Application with the U.S. Food and Drug Administration in December 2025 for CagriSema for weight management, and a decision is expected in the fourth quarter of 2026 [1][2]. CNBC reported the drug is expected to launch early next year [3]. Analysts expect CagriSema to generate $11.84 billion in obesity sales in 2028, according to a FactSet consensus estimate [3].
Images from the sources
Sources
- https://www.biospace.com/press-releases/novos-cagrisema-was-associated-with-25-weight-loss-on-average-for-women-in-a-post-hoc-analysis-of-redefine-1-presented-at-the-menopause-society-annual-meeting
- https://www.reuters.com/legal/litigation/novos-cagrisema-helped-women-lose-25-weight-average-analysis-shows-2026-10-20/
- https://www.cnbc.com/2026/10/20/novo-cagrisema-women-weight-loss-analysis.html
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