CagriSema post hoc analyses: 25% average weight loss in women at week 68 of REDEFINE 1, sustained across menopause stages
Novo Nordisk reported two post hoc analyses of the phase 3 REDEFINE 1 trial, presented at The Menopause Society 2026 Annual Meeting. In 2,309 women with obesity or overweight, investigational once-weekly CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg) was associated with 25.0% average weight loss at week 68 versus 3.0% with placebo; a second analysis of 1,902 women found similar results across pre-, peri- and postmenopausal groups. CagriSema is not approved.
The findings come from two post hoc analyses of REDEFINE 1, a 68-week, double-blind, placebo- and active-controlled phase 3 trial of once-weekly CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg) versus placebo in 3,417 adults with obesity or overweight, at least one comorbidity, and no type 2 diabetes. Novo Nordisk announced the analyses on October 20, 2026; they were presented at The Menopause Society 2026 Annual Meeting in San Diego (posters P-50 and P-51, lead author Maria D. Hurtado Andrade of Mayo Clinic). The primary REDEFINE 1 results were published in the New England Journal of Medicine in 2025.
In the analysis of all 2,309 women enrolled in REDEFINE 1, CagriSema was associated with an average weight loss of 25.0% at week 68, compared with 3.0% with placebo, using the efficacy estimand (the result if all patients adhered to treatment). Waist circumference fell by 20.5 cm on average versus 4.7 cm with placebo. 68.7% of women on CagriSema achieved at least 20% bodyweight loss, versus 1.8% on placebo, and 93.3% achieved at least 10% loss, versus 12.7% on placebo. The reported p values were below 0.0001 but were not adjusted for multiplicity, and no formal treatment-by-sex interaction testing was performed.
In the second analysis, 1,902 women who received CagriSema or placebo were grouped post hoc by menopausal status using age, medical history, and recorded symptoms - not prospectively collected staging or biochemical confirmation. Average weight loss at week 68 was 26.7% in premenopausal women, 24.8% in perimenopausal women, and 23.1% in postmenopausal women, versus 2.1%, 1.7%, and 2.6% with placebo respectively.
On safety, the company cites the REDEFINE 1 trial overall: discontinuation due to adverse events occurred in 5.9% of CagriSema participants versus 3.5% on placebo. Adverse events were mainly gastrointestinal (79.6% versus 39.9%), including nausea (55% versus 12.6%), constipation (30.7% versus 11.6%) and vomiting (26.1% versus 4.1%), and were mostly transient and mild-to-moderate. Novo Nordisk filed a New Drug Application for CagriSema for weight management in December 2025, with an FDA decision expected in the fourth quarter of 2026. CagriSema is not approved for use in the United States, and its safety and efficacy are not established.
The limits matter. Both analyses are post hoc rather than pre-specified, the menopause groupings were derived after the fact without hormonal confirmation, the reported figures use the efficacy estimand rather than the treatment-policy estimand, and the results are company-reported conference data. They describe average effects in trial populations, not expected outcomes for any individual.