Novo Nordisk announced on October 20, 2026, that its investigational obesity treatment CagriSema was associated with average weight loss of 25.0% after 68 weeks in an analysis of women from the phase 3 REDEFINE 1 trial. The CagriSema results assume patients remained on treatment and used no other weight-loss therapies; they come from exploratory analyses, not new standalone trials.
Key Takeaways
- Average weight loss among women was 25.0% with CagriSema versus 3.0% with placebo under treatment-adherence assumptions.
- A separate exploratory analysis found weight loss across premenopausal, perimenopausal and postmenopausal groups.
- CagriSema remains unapproved in the United States, with an FDA decision expected in the fourth quarter of 2026.
Table of Contents
- CagriSema results add detail to the REDEFINE 1 trial
- Menopause findings carry important research limits
- Safety findings and the pending FDA decision
- Conclusion
CagriSema results add detail to the REDEFINE 1 trial
The findings were presented at The Menopause Society’s 2026 Annual Meeting in San Diego. Novo Nordisk’s announcement of the REDEFINE 1 analyses described two post hoc assessments, meaning researchers examined the data after the trial rather than conducting separate prospective studies.
The first analysis covered all 2,309 women enrolled in REDEFINE 1. At week 68, estimated average weight loss was 25.0% with CagriSema, compared with 19.0% with semaglutide alone, 13.4% with cagrilintide alone and 3.0% with placebo.
CagriSema combines 2.4 mg of semaglutide, a GLP-1 receptor agonist, with 2.4 mg of cagrilintide, a long-acting amylin analog, in a once-weekly injection. The comparison with each component provides context for the combination’s results, rather than measuring its effect against placebo alone.
The underlying 68-week trial enrolled 3,417 adults with obesity or overweight and at least one associated condition, without type 2 diabetes. The women-only findings should not be read as results for the entire trial population.
| Item | Details |
|---|---|
| Premenopausal women | Estimated weight loss at week 68: 26.7% with CagriSema versus 2.1% with placebo. |
| Perimenopausal women | Estimated weight loss at week 68: 24.8% with CagriSema versus 1.7% with placebo. |
| Postmenopausal women | Estimated weight loss at week 68: 23.1% with CagriSema versus 2.6% with placebo. |
Menopause findings carry important research limits
The second analysis evaluated 1,902 women receiving CagriSema or placebo by menopausal status. Estimated weight loss was greater with CagriSema in each of the three reproductive-stage groups shown below.
However, menopausal status was assigned after the fact using age, medical history and recorded symptoms. It was not based on prospectively collected reproductive staging or biochemical confirmation. Women using hormone therapy were evaluated separately.
Both analyses used an efficacy estimand: an estimate of outcomes in an idealized scenario in which all patients stayed on treatment and took no other weight-loss therapies. These figures therefore should not be treated as average outcomes regardless of treatment discontinuation.
Novo described the exploratory analyses as hypothesis-generating. Maria D. Hurtado Andrade, the analyses’ lead author and an assistant professor at Mayo Clinic Alix School of Medicine, said the numerical differences between groups warrant further research into how reproductive aging may influence weight-loss outcomes.
Safety findings and the pending FDA decision
Across the overall REDEFINE 1 trial, adverse events led 5.9% of CagriSema participants to discontinue treatment, compared with 3.5% receiving placebo. Gastrointestinal adverse events occurred in 79.6% and 39.9%, respectively, and were mostly transient and mild to moderate in severity.
Novo filed a New Drug Application for CagriSema for weight management with the U.S. Food and Drug Administration in December 2025. The company expects a decision in the fourth quarter of 2026. CagriSema is not approved for U.S. use, and its safety and efficacy have not been established.
Conclusion
The analyses provide additional evidence on CagriSema’s effects in women, but their retrospective design and treatment-adherence assumptions limit what can be concluded. The next identified regulatory milestone is the FDA decision Novo expects in the fourth quarter of 2026.
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