The purpose of this study is to evaluate the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adult participants living with obesity or overweight with or without T2DM.
Adult participant aged 18 years or older at the time of informed consent.
28 kg/m² or higher, or
24 kg/m² to less than 28 kg/m² with at least 1 weight-related comorbidity.
Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)
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.
Have had more than one episode of severe hypoglycemia within 180 days prior to the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
Parallel
Elecoglipron
DrugElecoglipron film coated tablet once daily
Placebo
DrugPlacebo matching elecoglipron film-coated tablet once daily
Percent change from baseline to Week 52 in body weight
Percent change from baseline to Week 52 in body weight.
Participants achieving at least 5% body weight loss at Week 52
Achieved at least 5% body weight loss from baseline at Week 52.
Participants achieving at least 10% body weight loss at Week 52
Achieved at least 10% body weight loss from baseline at Week 52.
Change in waist circumference from baseline to Week 52
Absolute change from baseline to Week 52 in waist circumference(cm).
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