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We believe these data underscore the potential of CagriSema to address unmet medical needs in obesity and support long-term disease management." The NDA is based on results from REDEFINE 1, a 68-week, phase 3, randomized, double-blind, placebo-and active-controlled trial that evaluated the efficacy and safety of once-weekly CagriSema compared to semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone, or placebo, all as an adjunct to lifestyle intervention in 3,417 adults with obesity (BMI 30 kg/m 2 ) or overweight (BMI 27 kg/m 2 ) with one or more obesity-related complications and without diabetes, and REDEFINE 2, a double-blind, randomized, placebo-controlled, 68-week, phase 3 trial that evaluated the efficacy and safety of once-weekly CagriSema versus placebo, as an adjunct to lifestyle intervention in 1,206 adults with type 2 diabetes and either obesity (BMI 30 kg/m 2 ) or overweight (BMI 27 kg/m 2 )
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It affects skeletal muscle (impaired glucose uptake), the liver (impaired glycogen synthesis), and paradoxically, the ovaries (which remain sensitive to insulin's androgen-stimulating effects)
