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The NDA is based on results from REDEFINE 1, a 68-week, phase 3, randomised, 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/m2) or overweight (BMI 27 kg/m2) with one or more obesity-related complications and without diabetes, and REDEFINE 2, a double-blind, randomised, 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/m2) or overweight (BMI 27 kg/m2)
Improved metabolic health from treatment may actually enhance sexual function over time for many patients, though the initial adjustment period can be challenging
Edge activators cause lipid vesicles bilayer membrane to become less stable, become more deformable, and facilitate vesicles passage through the skins micropores while avoiding the stratum corneum barrier, which is the primary barrier and rate-limiting step for drug diffusion through the skin (163, 164)
