■ReadoutGlobal29 Oct 20266 min read
CagriSema menopause data show weight loss above 23 percent in every stage
A post hoc REDEFINE 1 analysis of 1,902 women finds mean weight loss of 23.1% to 26.7% at 68 weeks in every menopause stage and in hormone therapy users. The gaps between groups were never formally tested, and CagriSema stays filed.
Holds at Filed Mixed or neutral: news, but no net change in prospects.
The readEvery group of women in REDEFINE 1 lost far more weight on CagriSema than on placebo, which supports a broad effect across reproductive stages. The tilt toward younger women was never formally tested and may reflect age. This is a reanalysis of data already known, so the molecule stays filed and the REDEFINE 4 gap to tirzepatide still stands.
New CagriSema menopause data suggest that Novo Nordisk's amylin and GLP-1 combination worked across reproductive stages in its main phase 3 obesity trial. A post hoc look at 1,902 women in REDEFINE 1, shown at The Menopause Society 2026 Annual Meeting in San Diego, found mean weight loss between 23.1% and 26.7% at 68 weeks in every group, including women on hormone therapy. The molecule remains filed and unapproved. The analysis does not change its stage, and its authors say plainly that the gaps between groups were never formally tested.
What the REDEFINE 1 subgroup poster measured
REDEFINE 1 (NCT05567796) was a 68 week, double blind phase 3a trial that enrolled 3,417 adults with obesity, or with overweight plus at least one related condition, and without type 2 diabetes. People were randomized to CagriSema, semaglutide alone, cagrilintide alone or placebo, each on top of lifestyle advice. The new poster, led by Maria D. Hurtado Andrade of the Mayo Clinic Alix School of Medicine, took the 1,902 women from the CagriSema and placebo arms, 1,441 on the drug and 461 on placebo, and sorted them into four groups. Three were reproductive stages: premenopause, perimenopause and postmenopause. The fourth held every woman using menopausal hormone therapy, whatever her age or stage, according to coverage in Patient Care.
Menopause status was assigned retrospectively. Investigators used age, medical history, menstrual patterns and documented symptoms to place each woman, which limits how far the CagriSema menopause findings can be pushed. A companion poster pooled all 1,902 women regardless of stage and reported a mean weight loss of 25.0% on CagriSema against 3.0% on placebo, an estimated treatment difference of 22.1 percentage points. In that pooled group, 29.5% of women on the drug lost at least 30% of their body weight, compared with 0.3% on placebo. We covered the first wave of these numbers in our earlier REDEFINE 1 women report. The table below sets out what this REDEFINE 1 post hoc analysis found in each group at week 68.
| Group at week 68 | Mean weight loss on CagriSema | Mean weight loss on placebo | Lost 20% or more on CagriSema |
|---|---|---|---|
| Premenopause | 26.7% | 2.1% | 78.3% |
| Perimenopause | 24.8% | 1.7% | 70.4% |
| Postmenopause | 23.1% | 2.6% | 63.2% |
| Hormone therapy users | 25.6% | 2.3% | 69.4% |
| All women pooled | 25.0% | 3.0% | 68.7% |
Hormone therapy users and postmenopausal women
The hormone therapy group is the one that doctors in menopause care are likely to read first, because it gathers women of different ages and stages who share one treatment. Women on hormone therapy lost a mean 25.6% of body weight on CagriSema, against 2.3% on placebo, and 69.4% of them lost at least a fifth of their weight. That places the group between the premenopausal and postmenopausal results rather than at either edge. Postmenopausal women had the smallest mean loss at 23.1%, yet even in that group 63.2% of women passed the 20% mark. Across all four groups, between 91.0% and 95.1% of women on the drug lost at least 10%, and waist size fell by about 19 to 22 centimetres, the poster reports.
Postmenopausal women had the smallest mean loss at 23.1%, yet even in that group 63.2% of women passed the 20% mark.
Cardiometabolic markers moved in the same direction. The authors report significant improvements in blood pressure, fasting plasma glucose and triglycerides in every subgroup, while changes in cholesterol were mixed. In the pooled analysis of all women, systolic blood pressure fell by 11.1 mmHg on CagriSema compared with 2.0 mmHg on placebo, and diastolic pressure fell by 5.6 mmHg against 1.3 mmHg. Hurtado Andrade called the weight loss in each group "encouraging" in a Novo Nordisk press release, and said the numerical differences pointed to a need for more research on how reproductive aging shapes weight loss. Michelle Skinner Moore, a vice president of medical affairs at the company, said it is important to study CagriSema across the reproductive lifespan.
Why the stage gaps are not proof of a menopause effect
The headline pattern is a gradient. The premenopausal group lost the most and the postmenopausal group the least, a gap of 3.6 percentage points in mean weight loss. It is tempting to read that as a sign that menopause blunts the drug, but the data cannot carry that claim. The authors state that no formal treatment by subgroup interaction tests were run, so the study does not show that menopause status or hormone therapy use changes the response. Age also travels with stage. Postmenopausal women are older on average than premenopausal women, so age rather than hormones could explain some or all of any gap that a proper test might find.
Three more limits apply. First, this is a post hoc split of a trial built to answer a different question, namely whether CagriSema beats placebo and its two parts in adults with obesity. Second, stage was inferred after the fact from records and symptoms, which can misplace women at the edges, especially around perimenopause. Third, hormone therapy users were pulled into their own group whatever their stage, which mixes ages and makes that row hard to compare with the others. None of this undercuts the main result, since every group lost far more weight on CagriSema than on placebo. What the CagriSema menopause analysis offers is evidence of a broad effect, not a guide to who benefits most.
CagriSema FDA decision and the REDEFINE 4 result
These posters arrive while regulators weigh the drug. CagriSema sits at the filed stage on our board, and the CagriSema FDA decision is anticipated in late 2026, according to Drug Topics. The menopause analysis is unlikely to decide that review on its own, because it reuses data from REDEFINE 1 rather than adding a new trial. The harder question for the molecule is how it stacks up against rivals. In the head to head REDEFINE 4 trial of 809 people, CagriSema produced a mean weight loss of 23% over 84 weeks but did not show noninferiority to the highest tirzepatide dose, which reached 25.5%, as Drug Topics reported on October 25 in its recap of the program.
Safety across the CagriSema trials has been dominated by gastrointestinal effects, mainly nausea and diarrhea, which were mostly mild to moderate and faded over time, according to the same summary. Serious adverse events did not differ significantly from comparators in pooled data, the outlet added. The amylin field is also getting crowded, and Lilly is now pairing its own amylin analog with tirzepatide in two trials covered in our EloraTZP phase 3 story. Separately, a Bayesian CagriSema diabetes meta analysis found a clear weight edge over semaglutide alone. For Novo Nordisk, consistent subgroup data support the case that the effect is broad, but they do not close the gap that REDEFINE 4 exposed.
Conclusion
The CagriSema menopause analysis shows that weight loss in REDEFINE 1 stayed large in every group of women studied, from premenopause to hormone therapy users, with mean losses between 23.1% and 26.7% at 68 weeks. The tilt toward younger women is untested and may reflect age. The molecule's stage does not move. The next checkpoint is the FDA decision expected in late 2026 and how regulators weigh REDEFINE 4 against these consistent results. This story is research reporting, not medical advice.
The US FDA decision on CagriSema, which Drug Topics reports is anticipated in late 2026, and whether a full publication of the menopause analysis adds formal subgroup interaction testing.
Primary sourceHurtado Andrade et al, poster P-50, The Menopause Society 2026 Annual Meeting, San Diego, October 20 to 24, 2026, as reported by Drug Topics and Patient Care
Sources
Spotted an error? Tell us through the contact form; corrections follow the corrections policy.
