Novo's CagriSema linked to 25% average weight loss in women in post-trial analysis

Novo Nordisk's experimental obesity injection CagriSema was linked to an average 25% body weight loss among women at 68 weeks in new post-hoc analyses of its Phase 3 REDEFINE 1 trial — results that exceed the drug's overall trial average and were presented at The Menopause Society 2026 Annual Meeting.

The analyses covered roughly 2,300 women with obesity or overweight, who lost an average of 25% of their body weight on CagriSema compared with 3% on placebo, under an efficacy model that assumes all patients stayed on treatment without interruption. A separate analysis of around 1,900 women grouped by menopausal status found weight loss of 26.7% in premenopausal women, 24.8% in perimenopausal women, and 23.1% in postmenopausal women at 68 weeks, versus approximately 2% across all menopause groups on placebo.

Both analyses are post-hoc — meaning they were conducted after the main trial concluded — and Novo said further work is needed to confirm their findings. The results nonetheless push above the 22.7% average weight loss the full REDEFINE 1 trial population, which was roughly 67% women, recorded at 68 weeks against 2.3% for placebo.

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 Nordisk Interim Head of Clinical Development, Medical and Regulatory Affairs

CagriSema is a once-weekly injectable that combines semaglutide — the active ingredient in Novo's blockbuster obesity drug Wegovy and diabetes drug Ozempic — with cagrilintide, a long-acting amylin analog. Amylin is a hormone released in the pancreas alongside insulin that helps regulate hunger and fullness.

Across both analyses, CagriSema was also associated with reductions in abdominal fat as measured by waist circumference, in women overall and across all menopausal stages, Novo said.

The menopausal angle matters for a large potential patient population. More than 86 million women in the U.S. are 40 and older, according to the U.S. Census Bureau — the years in which perimenopause, menopause, and postmenopause typically occur. Declining estrogen during this period can slow metabolism, making weight gain easier and muscle maintenance harder, according to CNBC.

The new CagriSema data arrived alongside separate findings on Novo's existing drug Wegovy, presented at the European Congress on Obesity in Istanbul. A post-hoc analysis of the STEP UP trial found that premenopausal women with obesity lost an average of 22.6% of their body weight on high-dose Wegovy (semaglutide 7.2 mg), with more than four in ten achieving 25% or more weight loss. Perimenopausal and postmenopausal women in that trial lost 19.7% and 19.8%, respectively, under the same adherence assumption.

Menopause, associated weight gain and unwanted changes in cardiometabolic markers can significantly impact long-term health and well-being of women. Still, they remain one of the most neglected areas in obesity research.— Dr. Emilia Huvinen, Gynaecologist Researcher and Associate Professor, University of Helsinki

A post-hoc analysis of Novo's SELECT cardiovascular trial also found that perimenopausal and postmenopausal women with obesity and existing heart disease saw meaningful risk reductions in heart attacks, strokes, and cardiovascular death on semaglutide. Perimenopausal women showed a numerically larger risk reduction — 42% lower than placebo — compared with 13% lower for postmenopausal women, though the difference between the two groups was not statistically significant, according to hospitalsmagazine.com.

A separate real-world U.S. study of more than 34,000 women during menopause found that those taking Wegovy alone had an average 42–45% lower risk of migraine starting six months after initiation, and a 25% lower risk of depression, compared with menopausal hormone therapy alone, according to hospitalsmagazine.com.

Wall Street has been cautious about CagriSema since earlier Phase 3 results came in below investor expectations for weight loss efficacy. Novo maintains the drug is sufficiently differentiated from its existing portfolio to generate significant demand. Analysts tracked by FactSet project CagriSema will generate $11.84 billion in obesity-specific sales in 2028.

Why it matters — CagriSema's women-specific data, presented as a regulatory decision nears, could shape prescribing patterns for tens of millions of women navigating menopause-related weight gain — if the exploratory findings hold up under further study.

Reported by reuters.com, ml-eu.globenewswire.com, cnbc.com, rttnews.com, hospitalsmagazine.com