- CagriSema was associated with an average weight loss of 25.0% among women at week 68, according to a post hoc analysis of the REDEFINE 1 trial.
- The second analysis revealed that weight loss varied by menopause stage, with 26.7% in premenopausal, 24.8% in perimenopausal, and 23.1% in postmenopausal women.
- Novo filed a New Drug Application with the FDA in December 2025, with a decision expected in Q4 2026.
- The full trial of REDEFINE 1 indicated an average weight loss of 22.7% in adults over 68 weeks, compared to 2.3% for placebo.
- Waist circumference among women on CagriSema decreased by 20.5 cm on average, compared to 4.7 cm for those on placebo.
- The trial included 2,309 women with obesity or overweight, highlighting the drug's effectiveness in this demographic.
Novo Nordisk's CagriSema, a combination of semaglutide and cagrilintide, showed promising results in the phase 3 REDEFINE 1 trial, with an average weight loss of 25% among women after 68 weeks. The trial included 2,309 women with obesity or overweight, revealing significant differences based on menopausal status.16
In a second analysis of 1,902 women, weight loss varied by menopause stage: 26.7% for premenopausal, 24.8% for perimenopausal, and 23.1% for postmenopausal participants. In contrast, placebo groups lost only 2.1%, 1.7%, and 2.6% respectively.2
Additionally, waist circumference decreased by an average of 20.5 cm in the CagriSema group compared to 4.7 cm in the placebo group. However, 5.9% of participants on CagriSema discontinued treatment due to adverse events, primarily gastrointestinal issues affecting 79.6% of the group.5
Michelle Skinner Moore, Novo's interim head of clinical development, emphasized the importance of exploring treatments like CagriSema for women experiencing weight gain during menopause. Maria D. Hurtado Andrade from Mayo Clinic noted the need for further research on how reproductive aging impacts weight loss.
Novo has filed a New Drug Application with the FDA, with a decision expected in the fourth quarter of 2026. Analysts project CagriSema could generate $11.84 billion in sales for obesity by 2028.3
“In a second analysis of 1,902 women grouped by menopause stage, losses were 26.7% for premenopausal, 24.8% for perimenopausal, and 23.1% for postmenopausal. Novo has filed for FDA approval, with a decision expected in the fourth quarter of 2026.”
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