A Study to Investigate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus

This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of oral elecoglipron in adults with obesity or overweight, with or without type 2 diabetes mellitus. Participants will be randomized to receive elecoglipron or placebo in accordance with the study protocol. Efficacy and safety will be assessed throughout the study.

Inclusion criteria

• Adult participant aged 18 years or older at the time of informed consent.
• Body mass index (BMI) at screening of:
• 28 kg/m^2 or higher, or
• 24 kg/m^2 to less than 28 kg/m^2 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)
• History of at least 1 self-reported unsuccessful dietary effort to lose body weight.
• Participants with type 2 diabetes mellitus, if enrolled, and have HbA1c from 6.5% to less than 10.0% at screening.

Exclusion criteria

• Any of the following medical history, laboratory values, or complications related to diabetes:
• 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.
• History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis.
• History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2.