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)

Condition studied

Participants Living with Obesity or Overweight with at least 1 comorbidity with or without Type 2 Diabetes Mellitus

Investigational medicinal product(s)

Eligibility

Primary endpoint

Percent change from baseline to Week 72 in body weight

Endpoint detail

Absolute change from baseline to Week 72 in body weight, Achieved ≥ 5% body weight loss from baseline at Week 72, Achieved ≥ 10% body weight loss from baseline at Week 72, Achieved ≥ 15% body weight loss from baseline at Week 72, Percent change from baseline to Week 72 in body weight in participants with BMI ≥ 27 kg/m2 at baseline, Absolute change from baseline to Week 72 in waist circumference (cm), Change from baseline to Week 72 in hemoglobin A1c (HbA1c) (%), Achieved normoglycemia (HbA1c < 5.7% [39 mmol/mol]) at Week 72 in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline Study 2 only: • Achieved HbA1c < 7.0% (53 mmol/mol) at Week 72 in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline Study 2 only: • Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 72 in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline, Change from baseline to Week 72 in systolic blood pressure (mmHg)