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).
Legal age of consent and at least 18 years old
Study 1 -
BMI ≥ 30 kg/m2 or
Hypertension
Study 1 - Established diagnosis of T1DM or T2DM.
T1DM
HbA1c ≥ 10% (86 mmol/mol) at the screening visit
Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema.
Parallel
Elecoglipron
DrugElecoglipron film-coated tablet once daily
Placebo
DrugPlacebo matching elecoglipron film-coated tablet once daily
Percent body weight loss
Percent change from baseline to Week 72 in body weight
Absolute body weight loss
Absolute change from baseline to Week 72 in body weight (kg)
Total body weight loss of at least 5%, 10%, and 15%
* 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 body weight loss in participants with body mass index (BMI) ≥ 27 kg/m2 at baseline
Percent change from baseline to Week 72 in body weight
Waist circumference reduction
Absolute change from baseline to Week 72 in waist circumference (cm)
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