Novo Nordisk said an analysis of women in its CagriSema obesity trial estimated 25% weight loss after 68 weeks, offering fresh evidence as U.S. regulators consider the experimental injection.
The figure comes from an analysis of 2,309 women with obesity or overweight. It assumes participants stayed on their assigned treatment and used no other weight-loss medicine, so it describes a continuous-treatment scenario rather than outcomes across all participants.
Of those women, 1,441 were assigned to CagriSema, 199 to semaglutide, 208 to cagrilintide and 461 to placebo. Under the same assumption, Novo estimated weight loss of 19% for the semaglutide group and 3% for the placebo group.
The earlier REDEFINE 1 trial randomized 3,417 adults across four treatment groups. For those assigned to CagriSema, estimated weight loss was 22.7% under the continuous-treatment assumption. A separate analysis that counted outcomes regardless of whether participants stopped treatment or used another weight-loss drug put the figure at 20.4%.
Another analysis examined 1,902 women grouped by menopause status, including CagriSema and placebo recipients. Among those assigned to CagriSema, estimated weight loss was 26.7% for premenopausal women, 24.8% for perimenopausal women and 23.1% for postmenopausal women. Women using hormone therapy were assessed separately.
Researchers reconstructed the menopause categories after the trial from participants’ ages, medical histories and recorded symptoms, without prospective staging or biochemical confirmation. The exploratory analyses did not formally test whether treatment effects differed by sex or menopause group, so the figures do not establish that one group benefited more than another.
CagriSema combines Wegovy’s active ingredient, semaglutide, with the amylin analogue cagrilintide in a weekly injection. In the full trial, adverse events led 5.9% of CagriSema recipients to stop treatment, compared with 3.5% of placebo recipients. Gastrointestinal problems were the most common adverse events.
Novo applied for U.S. approval in December 2025. CagriSema is not approved in the United States, and the company expects a Food and Drug Administration decision in the fourth quarter of 2026.
