Novo said Tuesday that its next-generation obesity drug, CagriSema, showed an average 25% weight loss in adult women in a new analysis conducted after a late-stage trial.
The Danish company said further work was needed to confirm the hypotheses of two post-study analyses. Still, the findings are the latest evidence that the experimental injection can enhance weight loss and other benefits offered by Novo’s GLP-1 drug semaglutide, the active ingredient in its blockbuster obesity vaccine, Wegovy, and its diabetes counterpart, Ozempic.
CagriSema, a combination of semaglutide and another drug called cagrilintide that targets the amylin pathway, is expected to launch early next year. Novo and Eli Lilly, leaders in obesity drugs, have built new treatments around amylin, which involves a hormone released in the pancreas alongside insulin that helps regulate hunger and satiety, in the hope that it will give them a new revenue stream beyond existing GLP-1.
In an analysis of about 2,300 obese or overweight women, CagriSema resulted in a 25% weight loss on average at 68 weeks, compared to 3% with placebo. The results are based on an ideal scenario in which all patients followed treatment without interruption.
A second analysis of about 1,900 women categorized by their menopausal status found that weight loss reached 26.7%, 24.8% and 23.1% in premenopausal, perimenopausal and postmenopausal women, respectively, at 68 weeks, if all patients continued to take the drug. This compares to about 2% in the postmenopausal groups who received a placebo.
In both analyses, CagriSema was associated with a reduction in abdominal fat, based on waist circumference, in women overall and at all stages of menopause, Novo added.
The results suggest that women may experience slightly greater weight loss with CagriSema than a broader population of obese men and women saw in the phase 3 trial.
Initial study results showed that CagriSema helped adults lose 22.7% of their weight on average at 68 weeks, compared to 2.3% in the placebo group. However, the majority of patients in the trial – about 67% of about 3,400 – were women.
Weight gain is very common among women during menopause. Declining estrogen levels can contribute to a slowed metabolism, making it easier for women to gain weight and harder to maintain muscle mass. After menopause, estrogen usually remains low and does not return to previous levels.
In the United States, more than 86 million women are 40 and older, according to the U.S. Census Bureau, years during which perimenopause, menopause, and postmenopause occur.
“Many obese or overweight women experience weight gain as they progress through menopause, and it is important to explore investigational products such as CagriSema throughout the reproductive lifespan,” said Michelle Skinner Moore, Novo’s interim head of clinical development, medical and regulatory affairs.
Wall Street doesn’t seem particularly enthusiastic about CagriSema, whose previous late-stage clinical trial results disappointed investors because the drug showed lower weight-loss effectiveness than their expectations. Novo, however, maintains that CagriSema is effective and sufficiently differentiated from its other drugs to generate significant demand.
Analysts expect CagriSema to generate $11.84 billion in sales for obesity specifically in 2028, according to a consensus estimate compiled by FactSet.
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