A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (Embold)
AstraZeneca
Summary
This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).
Description
This is a Phase III, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 2 doses of elecoglipron compared with placebo, given once daily as oral tablets. This protocol covers two independent pivotal studies in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 25 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Prediabetes, Dyslipidemia, CV disease and/or Obstructive sleep apnea) without T2DM (Study 1) and as well as those who are living with obesity or o…