Elecoglipron for weight management in adults with obesity or overweight 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 global, Phase 3 program consisting of two independent, pivotal, randomized, double-blind, placebo-controlled studies. Participants are adults with obesity (BMI ≥30) or overweight (BMI ≥25) with at least one weight-related comorbidity, enrolled to receive either elecoglipron at two doses or placebo, alongside lifestyle guidance. Study 1 targets those without type 2 diabetes, while Study 2 includes participants with type 2 diabetes; both use a 72-week primary endpoint measuring percent change in body weight from baseline. Approximately 4,500 participants are planned (3,000 in Study 1 and 1,500 in Study 2) across multiple global centers. Primary safety and efficacy outcomes focus on weight loss and adverse events in a parallel-group design.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Legal age of consent and at least 18 years old
* Study 1 -

  * BMI ≥ 30 kg/m2 or
  * 25 kg/m2 ≤ BMI \< 30 kg/m2 with at least one of the following weight-related comorbidities:
  * Hypertension
  * Prediabetes
  * Dyslipidemia
  * Cardiovascular disease
  * Obstructive sleep apnea.
* Study 2 - BMI ≥ 25 kg/m2 and T2DM defined as below:

  * Established diagnosis of T2DM
  * Without established diagnosis of T2DM and HbA1c ≥ 6.5% (48 mmol/mol) at the screening visit
* Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)
* History of at least one self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria

* Study 1 - Established diagnosis of T1DM or T2DM.
* Study 2 - 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
  Birmingham, Alabama, United States Recruiting
• Research Site
  Dothan, Alabama, United States Recruiting
• Research Site
  Chandler, Arizona, United States Recruiting
• Research Site
  Little Rock, Arkansas, United States Recruiting
• Research Site
  Lynwood, California, United States Recruiting
• Research Site
  Rolling Hills Estates, California, United States Recruiting

+275 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Prof. Melanie Davies, MBChB — Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester
• 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.