CagriSema weight loss in women averages 25 percent in REDEFINE 1 subgroups

Novo has put fresh numbers on CagriSema weight loss in women, drawn from two post hoc analyses of the phase 3 REDEFINE 1 trial. They were presented on 20 October at The Menopause Society 2026 Annual Meeting in San Diego. Across 2,309 women, the company reports an average loss of 25.0 percent at week 68 against 3.0 percent on placebo, under an estimand that assumes everyone stayed on treatment. The molecule does not move on our board: it remains filed in the US, with a decision expected in the fourth quarter of 2026.

What the two analyses measured

REDEFINE 1 randomised 3,417 adults with obesity or overweight, at least one related condition and no type 2 diabetes, to weekly CagriSema, either of its two parts alone, or placebo for 68 weeks. About two thirds of the people enrolled were women, and the first analysis pools all 2,309 of them. Novo reports the figures under the efficacy estimand, which models an ideal case in which every participant keeps taking the drug and uses no other weight loss treatment. That choice matters. In the main trial paper, which used the treatment policy approach that counts people who stopped, the whole population lost 20.4 percent on CagriSema against 3.0 percent on placebo. The figure for CagriSema weight loss in women is best read as an upper bound, not as a like for like match for that headline result.

Beyond the scale, the release adds waist and threshold data for the same women. Waist circumference fell by an average of 20.5 centimetres on CagriSema and 4.7 centimetres on placebo, a secondary endpoint that tracks abdominal fat. The share of women reaching at least a tenth of body weight lost was 93.3 percent on drug and 12.7 percent on placebo, and 68.7 percent of treated women lost a fifth or more, compared with 1.8 percent on placebo. Novo says these differences were statistically significant against placebo, but adds two qualifiers that a careful reader should keep. The p values were not adjusted for multiple comparisons, and no formal test checked whether the effect in women differs from the effect in men. The numbers describe women in the trial; they do not show that women respond better.

How the REDEFINE 1 post hoc analysis split women by menopause stage

The second piece of work is the more novel one. In this REDEFINE 1 post hoc analysis, 1,902 women who received CagriSema or placebo were sorted into premenopausal, perimenopausal and postmenopausal groups after the trial had ended. Women using hormone therapy were kept apart as a fourth group, and the release does not report their results. Weight loss on CagriSema was 26.7, 24.8 and 23.1 percent across the three stages, each far above placebo. The gradient looks tidy, falling a little with each later stage, but the lead author frames it as a question rather than an answer. Maria D. Hurtado Andrade of the Mayo Clinic said "the numerical differences among the groups highlight the need for further research" on how reproductive ageing shapes the response.

About two thirds of the people enrolled were women, and the first analysis pools all 2,309 of them.

The method limits what the table can say. Menopause status was not collected prospectively and was not confirmed with hormone tests; it was assigned from age, medical history and recorded symptoms. Under that scheme, a woman under 45 with no sign of menopause counted as premenopausal, and anyone aged 55 or older counted as postmenopausal, so age and menopause stage are tangled together. Older age alone could explain part of the smaller loss in later groups. As with the pooled analysis, no formal test compared the groups with each other. Novo itself calls the work exploratory and hypothesis generating. For context on menopause and obesity, the company notes that hormonal shifts in midlife can favour fat gain around the abdomen, which is why a stage by stage view is worth testing in a trial built for it.

Safety and the wider REDEFINE 1 record

The tolerability data in the release come from the full trial, not from the women alone, so they say nothing new about this subgroup. Across REDEFINE 1, gastrointestinal adverse events affected 79.6 percent of people on CagriSema and 39.9 percent on placebo. Nausea was reported by 55 percent against 12.6 percent, constipation by 30.7 percent against 11.6 percent, and vomiting by 26.1 percent against 4.1 percent. Novo describes these events as mostly transient and mild to moderate. Discontinuation because of adverse events was 5.9 percent on the combination and 3.5 percent on placebo. Those are the numbers regulators already hold. A subgroup readout of this kind cannot add a safety signal or remove one, because it reuses data that were collected and filed before the meeting.

Seen through our board, this is a molecule with a large phase 3 programme behind it rather than a single trial. CagriSema pairs cagrilintide, a long acting amylin analog, with semaglutide in one weekly injection, and it is the most advanced amylin and GLP 1 combination we track. Novo is also testing it in type 2 diabetes under the REIMAGINE programme. Readers following the class can compare it with Novo's earlier amycretin result, a single molecule that hits both receptors. They can also browse every amylin molecule on the board by stage. The new look at CagriSema weight loss in women adds detail to that record. It does not test a new dose, a new population outside the trial, or a new comparator, and so it leaves the competitive picture where it was.

What the data mean for the CagriSema FDA decision

Novo filed its New Drug Application for weight management with the FDA in December 2025 and says a decision is expected in the fourth quarter of 2026. That is the checkpoint that matters for the stage of this molecule, and nothing presented in San Diego changes the filing. Regulators judge the prespecified endpoints of the pivotal trials. Post hoc subgroups can shape how a drug is discussed with doctors after approval, but they rarely change the outcome of a review. The CagriSema FDA decision will rest on the full REDEFINE data set, its benefit and risk balance, and manufacturing review. Until then, CagriSema remains unapproved in the US, and Novo states plainly in its release on the women's analyses that its safety and efficacy are not established.

This is why we log the event as a readout with a flat signal rather than as a forward move. The figures are consistent with the trial's main result and give clinicians a first look at women by life stage. They also come with every caveat that applies to analyses designed after the data were in: no prospective staging, no multiplicity control, and a best case estimand. Our method treats such readouts as context, and our note on why stage moves differ explains how we weigh them. A genuine test of whether menopause stage changes the response would need prospective staging and enough women in each group. Nothing in the release says Novo plans such a study.

Conclusion

The new figures on CagriSema weight loss in women are large and consistent with the parent trial, but they come from analyses built after the fact, under a best case estimand, with menopause stage inferred rather than measured. They add context, not proof, and the molecule stays filed. The next checkpoint is the FDA decision Novo expects in the fourth quarter of 2026. This story is research news, not medical advice.