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

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (EMBOLD-Asia)

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.

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.