New Tuesday said the next generation obesity drug, CagriSema, showed a 25% average weight loss among adult women in a new analysis conducted after a late-stage trial.
The Danish company said further work is needed to confirm the hypothesis from the two post-study analyses. Still, these results are the latest evidence that experimental injections can improve body weight and other benefits offered by Novo’s GLP-1 drug semaglutide, the active ingredient in the obesity blockbuster taken by Wegovy and its diabetes partner Ozempic.
CagriSema, a combination of semaglutide and another drug called cagrilintide that targets the amylin pathway, is expected to be launched early next year. Obesity drug leaders Novo and Eli Lilly have developed a new treatment around amylin, which includes a hormone released in the pancreas along with insulin that helps regulate hunger and satiety, hoping to provide new revenue beyond existing GLP-1.
In an analysis of approximately 2,300 obese or overweight women, CagriSema resulted in an average weight loss of 25% in 68 weeks compared to 3% with placebo. These results are based on an ideal scenario where all patients remain in care without interruption.
A second analysis of approximately 1,900 women assigned to menopausal status found that weight loss was 26.7%, 24.8%, and 23.1% in premenopausal, perimenopausal, and postmenopausal women, respectively, at 68 weeks, if all patients continued to use the drug. That compares to about 2% between the menopause group and the placebo.
Between the two analyses, CagriSema was associated with a reduction in abdominal fat, based on waist circumference, among women overall and in the menopause stage, Novo added.
The results show that women may experience slightly more weight loss on CagriSema than the larger population of obese men and women in the phase 3 trial.
Preliminary results from the study showed that CagriSema helped adults lose 22.7% of their weight on average in 68 weeks compared to 2.3% in the placebo group. However, the majority of patients in the trial – about 67% of the approximately 3,400 – were women.
Weight gain is very common for women during menopause. Falling estrogen levels can contribute to a slowdown in metabolism, making it easier for women to gain weight and harder to maintain muscle mass. After menopause, estrogen generally remains low and does not return to previous levels.
More than 86 million women in the US age 40 and older, according to the US Census Bureau, are the years when 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 during their reproductive years,” said Michelle Skinner Moore, Novo’s interim head of clinical development, medical and regulatory affairs.
Wall Street hasn’t seemed too excited about CagriSema, whose late-stage clinical trial results previously disappointed investors as the drug showed weight-loss efficacy below expectations. Novo, however, maintains that CagriSema is effective and differentiated enough from other drugs to attract significant demand.
Analysts expect CagriSema to generate $11.84 billion in obesity-specific sales by 2028, according to consensus estimates compiled by FactSet.