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NCT07775404
A Study to Investigate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus
Conditions: Obesity, Overweight
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 351
Sponsor: AstraZeneca
Location: Research Site Baotou
Summary
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.
Eligibility 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.
Source: ClinicalTrials.gov (NCT07775404). StuddyBuddy aggregates publicly available trial information.