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A Study to Investigate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus
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.
ClinicalTrials.gov IDNCT07775404
PhasePHASE3
Enrollment351
SponsorAstraZeneca
Age18 Years and older
SexALL
Conditions studied
Obesity, Overweight
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.
Interventions
- Drug: Elecoglipron — Elecoglipron film coated tablet once daily
- Drug: Placebo — Placebo matching elecoglipron film-coated tablet once daily
Primary outcomes
- Percent change from baseline to Week 52 in body weight (Week 52)
- Participants achieving at least 5% body weight loss at Week 52 (Week 52)
Eligibility information
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.
Study locations
- Research Site, Baotou, 014040 China
- Research Site, Beijing, 100044 China
- Research Site, Beijing, 100050 China
- Research Site, Beijing, 102218 China
- Research Site, Changde, 415000 China
- Research Site, Changsha, 410015 China
- Research Site, Changzhou, 213000 China
- Research Site, Chengdu, 611130 China
- Research Site, Hefei, 230601 China
- Research Site, Huangshi, 435000 China
Showing 10 of 49 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-05.