A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes Mellitus
AstraZeneca · NCT07662213
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 1200
- US sites recruiting
- 13
- Study start
- July 6, 2026
- Record last updated
- October 22, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering medication(s).
Being studied: Elecoglipron; Semaglutide
Conditions: Type 2 Diabetes Mellitus
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Research Site
Phoenix, AZ 85016
Research Site
Encinitas, CA 92024
Research Site
Pomona, CA 91768
Research Site
Sacramento, CA 95821
Research Site
Lake City, FL 32055
Research Site
Leesburg, FL 34748
Research Site
Ames, IA 50010
Research Site
Rockville, MD 20852
Research Site
Henderson, NV 89052
Research Site
Morehead City, NC 28557
Research Site
Wilmington, NC 28403
Research Site
Houston, TX 77004
Research Site
Sugar Land, TX 77478
Study contacts (from the official record)
- AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com
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