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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)

J Orthomolecular Medicine

He does not just care about the players for what they do in the water

For context, the Phase 2 study (Jastreboff 2023, NEJM) reported about 17.5 percent mean weight reduction at 24 weeks on 12 mg