Can Elecoglipron help adults with type 2 diabetes compared with an existing medicine called semaglutide?

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 Phase 3 interventional trial compares Elecoglipron to oral semaglutide in adults with type 2 diabetes and elevated cardiovascular risk. Participants must have inadequately controlled diabetes on lifestyle changes or existing glucose-lowering therapies, and meet specific HbA1c and cardiovascular risk criteria. The study will assess efficacy, safety, and tolerability to determine if Elecoglipron offers similar or better outcomes compared with semaglutide. It is conducted at three sites in the United States and is sponsored by AstraZeneca. Eligible participants will undergo randomization and receive close monitoring over the study period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
* T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication(s)
* HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
* Increased risk of cardiovascular (CV) events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic cerebrovascular disease, or heart failure (NYHA II-III); or ≥2 CV risk factors
* Body mass index (BMI) of ≥ 23 kg/m2 at screening
* Stable body weight (self-reported or documented) for 90 days prior to screening

Exclusion Criteria:

* Type 1 Diabetes Mellitus (T1DM), secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
* 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 screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
* Clinically significant condition affecting the upper Gastrointestinal (GI) tract or chronic use of any medication that affects gastric motility or gastric emptying
* History of acute or chronic pancreatitis
* Severe congestive heart failure (NYHA IV)
* History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

Where it's running

• Research Site
  Phoenix, Arizona, United States Recruiting
• Research Site
  Encinitas, California, United States Recruiting
• Research Site
  Pomona, California, United States Recruiting
• Research Site
  Sacramento, California, United States Recruiting
• Research Site
  Lake City, Florida, United States Recruiting
• Research Site
  Leesburg, Florida, United States Recruiting

+160 more sites. See ClinicalTrials.gov for the full list.

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.