Clinical trial

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

Recruiting now · Phase 3 · 3 countries · Registry ID NCT07775404

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity, Overweight

Full registry criteria

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.

Treatments and study arms

Elecoglipron

Drug

Elecoglipron film coated tablet once daily

Placebo

Drug

Placebo matching elecoglipron film-coated tablet once daily

Primary outcomes

Percent change from baseline to Week 52 in body weightWeek 52

Percent change from baseline to Week 52 in body weight.

Participants achieving at least 5% body weight loss at Week 52Week 52

Achieved at least 5% body weight loss from baseline at Week 52.

Study locations

49 locations were listed when this page was built. The first 40 are shown.

Research Site🇨🇳 Baotou, China