Elecoglipron in adults who are overweight or obese with or without type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of oral elecoglipron in adults with obesity or overweight, with or without type 2 diabetes. Participants are assigned to elecoglipron or placebo and followed to assess weight change and safety in addition to lifestyle guidance. The study includes adults with BMI 28 or higher (or 24–<28 with a weight-related condition) who have not achieved weight loss with prior efforts. Diabetes status is allowed if HbA1c is between 6.5% and 10% at screening. Primary analyses compare weight loss between treatment and placebo over the planned period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Beijing, China Recruiting
• Research Site
  Beijing, China Recruiting
• Research Site
  Changde, China Recruiting
• Research Site
  Changsha, China Recruiting
• Research Site
  Changzhou, China Recruiting
• Research Site
  Chengdu, China Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.