This document details a Phase 3a, 68-week, multicenter, double-blind, placebo-controlled, and active-controlled clinical trial (REDEFINE 1) investigating the efficacy and safety of cagrilintide–semaglutide (CagriSema) for weight loss in adults who are overweight or obese. The study randomized over 3400 participants into groups receiving the combination therapy, semaglutide alone, cagrilintide alone, or placebo, alongside lifestyle interventions. Results demonstrated significant and clinically relevant body-weight reductions with CagriSema compared to placebo, with most adverse events being mild-to-moderate gastrointestinal issues. The findings suggest CagriSema is a highly effective treatment for weight management, improving not only body weight but also related health markers, though further research is warranted on specific aspects like lean soft-tissue mass reduction and application in exclusively overweight individuals.
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