A Study to Investigate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus
About this study
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.
- Condition
- Obesity, Overweight
- Tested
- Elecoglipron, Placebo
- Sponsor
- AstraZeneca
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 9
- Minimum age: 18 years
- Study condition: Obesity, Overweight
- 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 6
- Any of the following medical history, laboratory values, or complications related to diabetes:
- 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.
Where
49 sites, 48 recruiting
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Changde, China
Research Site
Changsha, China
Research Site
Changzhou, China
Research Site
Chengdu, China
and 43 more sites on ClinicalTrials.gov
Contact
-
AstraZeneca Clinical Study Information Center
1-877-240-9479 information.center@astrazeneca.com
Potential match only. Final eligibility is determined by the study team.