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PubMed: 33965067 Phase 2a: Weight Loss Efficacy Study (NCT03224429) Study Title: "Efficacy and Safety of Cagrilintide for Weight Management in Adults With Overweight or Obesity" Status: Completed Phase: Phase 2a Enrollment: 706 participants Study Period: 2018-2020 Location: Multi-country (US, Europe) Design: Randomized, double-blind, placebo-controlled Duration: 26 weeks Intervention: Cagrilintide 0.6/1.2/2.4/4.5 mg weekly Population: BMI 30 or 27 with comorbidity, no diabetes Key Results (26 Weeks): Mean Weight Loss: 10.8% at 4.5 mg (highest dose) 8.6% at 2.4 mg 6.0% at 1.2 mg 4.3% at 0.6 mg 3.0% with placebo 10% Weight Loss: 51% (4.5 mg) vs
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FDA evaluated emideltide free base and emideltide acetate for possible inclusion on the section 503A Bulks List
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