Novo's CagriSema Shows 25% Weight Loss in Women in Post-Trial Analysis

CagriSema combines semaglutide, the active ingredient in Novo's Wegovy and Ozempic, with cagrilintide, which targets the amylin pathway. The Danish company expects to launch the drug early next year. Novo and Eli Lilly have built new obesity treatments around amylin, a hormone released in the pancreas alongside insulin that helps regulate hunger and fullness, hoping to create a new revenue stream beyond existing GLP-1 drugs.

In an analysis of roughly 2,300 women with obesity or who were overweight, CagriSema caused 25% weight loss on average at 68 weeks, compared with 3% with placebo. The results are based on an ideal scenario in which all patients stayed on treatment without interruptions. Novo said further work is needed to confirm the hypotheses of the two post-study analyses.

A second analysis of around 1,900 women assigned by menopausal status found weight loss of 26.7%, 24.8% and 23.1% in premenopausal, perimenopausal and postmenopausal women, respectively, at 68 weeks if all patients remained on the drug. That compared with approximately 2% across menopause groups with placebo. Across both analyses, CagriSema was linked to reductions in abdominal fat, based on waist circumference, among women overall and across menopause stages, Novo said.

The results suggest women may experience slightly more weight loss on CagriSema than a broader population of both men and women with obesity saw in the phase 3 trial. Initial results from the study showed CagriSema helped adults lose 22.7% of their weight on average at 68 weeks versus 2.3% in the placebo group. However, about 67% of roughly 3,400 patients in the trial were women.

Weight gain is common for women during menopause. Declining estrogen levels can contribute to a slowdown in metabolism, making it easier for women to gain weight and harder to maintain muscle mass. More than 86 million women in the U.S. are 40 and older, according to the U.S. Census Bureau, the years in which perimenopause, menopause and postmenopause occur.

"Many women with obesity or overweight experience weight gain as they move through menopause, and it is important to explore investigational products such as CagriSema across the reproductive lifespan," said Michelle Skinner Moore, Novo's interim head of clinical development, medical and regulatory affairs.

Wall Street has not appeared particularly excited about CagriSema, whose previous late-stage trial results disappointed investors because the drug showed weight-loss efficacy below their expectations. Novo maintains CagriSema is effective and differentiated enough from its other drugs to draw 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.

Editor's Summary

Novo Nordisk reported that CagriSema led to 25% average weight loss in adult women at 68 weeks in a post-trial analysis, with smaller placebo effects and consistent reductions across menopausal stages. The drug is expected to launch early next year, though Novo said more work is needed to confirm the hypotheses. Analysts expect CagriSema to generate $11.84 billion in obesity sales in 2028.