On Tuesday, Novo Nordisk stated that in a new analysis conducted after the completion of a late-stage trial, its new generation weight loss drug CagriSema resulted in an average weight loss of 25% among adult women.
The Danish company stated that the hypotheses proposed after analyzing the two studies still require further work to confirm. Nevertheless, these results are still the latest evidence indicating that this experimental injectable drug may be superior to Novo Nordisk’s GLP-1 drug, semaglutide, in terms of weight loss and other benefits. Semaglutide is the active ingredient in its blockbuster weight loss injection Wegovy and the corresponding diabetes drug Ozempic.
CagriSema consists of semaglutide and another drug called cagrilintide, which targets the amyloid protein pathway, and is expected to be launched at the beginning of next year. The two leading companies in the weight loss drug sector, Novo Nordisk and Eli Lilly, are both developing new therapies around amyloid proteins. Amyloid proteins are involved in a hormone that is released in the pancreas along with insulin and helps regulate feelings of hunger and fullness; both companies hope that this will bring them new sources of revenue in addition to their existing GLP-1 drugs.
In an analysis involving approximately 2,300 obese or overweight women, CagriSema resulted in an average weight loss of 25% among participants after 68 weeks, compared to only 3% in the placebo group. These results are based on an ideal scenario where all patients continued treatment without interruption.
The second analysis grouped approximately 1,900 women according to their menopausal status. The results showed that, with all patients continuing to take the medication, the weight loss percentages at 68 weeks were 26.7% for pre-menopausal women, 24.8% for perimenopausal women, and 23.1% for post-menopausal women, respectively. In contrast, the weight loss percentage in the placebo group was around 2% across all menopausal stages.
Novo Nordisk added that in these two analyses, based on waist circumference data, CagriSema is associated with a reduction in abdominal fat in women overall as well as in women at various menopausal stages.
These results indicate that the weight loss achieved by women after using CagriSema may be slightly higher than that observed in the broader population of obese individuals, which included both men and women in this three-phase trial.
Preliminary results of this study show that CagriSema helped adult participants lose an average of 22.7% of their weight after 68 weeks, while the placebo group lost only 2.3%. However, the majority of patients in the trial—about 67% of the approximately 3,400 people—were women.
It is very common for women to experience weight gain during menopause. The decrease in estrogen levels can slow down metabolism, making it easier for women to gain weight and more difficult to maintain muscle mass. After menopause, estrogen levels usually remain low and do not return to their previous levels.
According to data from the U.S. Census Bureau, there are over 86 million women in the United States who are 40 years of age or older, and the perimenopausal, menopausal, and postmenopausal stages typically occur within this age group.
Michelle Skinner Moore, the interim head of clinical development, medical affairs, and regulatory affairs at Novo Nordisk, stated: "Many obese or overweight women experience weight gain during menopause, therefore, it is very important to explore research products such as CagriSema throughout a woman's reproductive life cycle."
Wall Street does not seem to have shown particularly high enthusiasm for CagriSema. Previously, the results of this drug in later clinical trials disappointed investors, as its weight loss efficacy was below their expectations. However, Novo Nordisk insists that CagriSema is effective and has sufficient differentiation from the company's other drugs to attract considerable demand.
According to the consensus forecast compiled by FactSet, analysts expect that the sales of CagriSema in the indication of obesity alone will reach $11.84 billion by 2028.
