New obesity drug linked to 25% weight loss among menopausal women

Novo Nordisk's CagriSema was associated with substantial weight loss among women in a phase 3 trial analysis. The exploratory findings span menopause stages but do not guarantee outcomes in routine practice.Danish drugmaker Novo Nordisk’s experimental obesity drug CagriSema has been associated with an average weight loss of 25% among women with overweight or obesity, according to a new analysis of a late-stage clinical trial.The findings raise the prospect of a more potent treatment in markets where injectable semaglutide and tirzepatide have gained ground, including in India.The fixed-dose drug combines GLP-1-based therapy semaglutide, the active ingredient in weight-loss drugs Ozempic and Wegovy, with cagrilintide, which mimics the appetite-regulating hormone amylin. Administered as a once-weekly injection, the combination targets two different pathways involved in appetite and food intake.The findings come from a post-hoc analysis of the phase 3 REDEFINE 1 trial, which enrolled more than 3,400 adults with overweight or obesity. Among 2,309 women analysed, those receiving CagriSema lost an average of 25% of their body weight after 68 weeks, compared with 3% among women given a placebo. WEIGHT LOSS ACROSS MENOPAUSEA separate analysis examined the drug’s effects across different stages of menopause, when hormonal changes can contribute to weight gain and increased abdominal fat.Average weight loss was 26.7% among premenopausal women, 24.8% among perimenopausal women and 23.1% among postmenopausal women. The findings suggest that substantial weight reduction may be possible across these stages. However, the results came from analyses conducted after the trial, and Novo has cautioned that they are exploratory and require further investigation.The figures also represent outcomes under a trial efficacy measure that assumes participants remained on treatment, rather than a guarantee of the weight loss patients can expect in routine clinical practice.HOW IT COMPARESCagriSema combines two mechanisms: semaglutide activates the GLP-1 receptor, which helps regulate appetite and blood sugar, while cagrilintide acts on the amylin pathway to influence satiety and food intake.Semaglutide, available as an injection and in oral formulations for different approved uses, works through the GLP-1 pathway alone. Tirzepatide, marketed in India under brands including Mounjaro and Yurpeak, acts on both GLP-1 and GIP receptors, another pathway involved in appetite regulation and glucose control.In the overall REDEFINE 1 trial, CagriSema produced an average weight loss of 22.7% after 68 weeks, below Novo’s 25% target. This compares with weight reductions of around 15% with semaglutide 2.4 mg in major obesity trials and around 20% with higher-dose tirzepatide in its pivotal trial.These are, however, cross-trial comparisons, not direct evidence that one drug is superior.In a separate head-to-head phase 3 trial, meanwhile, CagriSema produced 23% weight loss after 84 weeks but failed to demonstrate that it was non-inferior to tirzepatide 15 mg.CagriSema is currently only investigational and is not yet an available or approved treatment option anywhere in the world.- Ends