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

Recruiting now · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

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).

Key facts

Study ID: NCT07662213
Run by: AstraZeneca
People needed: 1200
Starts: 2026-07-06
Expected to finish: 2028-05-23
Last updated by the study team: 2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Research Site — Kamakura-shi, Japan (enrolling)
Research Site — Soham, United Kingdom (enrolling)
Research Site — Penzance, United Kingdom (enrolling)
Research Site — Nagoya, Japan (enrolling)
Research Site — East Toowoomba, Australia (enrolling)
Research Site — Vancouver, British Columbia, Canada (enrolling)
Research Site — Toronto, Ontario, Canada (enrolling)
Research Site — Naka, Japan (enrolling)
Research Site — Yate, United Kingdom (enrolling)
Research Site — Garden Grove, California, United States
Research Site — Crystal River, Florida, United States
Research Site — Bridgeport, Connecticut, United States
Research Site — Hollywood, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Encinitas, California, United States
Research Site — Phoenix, Arizona, United States
Research Site — Sacramento, California, United States
Research Site — Evansville, Indiana, United States
Research Site — Melrose Park, Illinois, United States
Research Site — Pomona, California, United States
Research Site — Ames, Iowa, United States
Research Site — Wichita, Kansas, United States
Research Site — Bowling Green, Kentucky, United States
Research Site — Rockville, Maryland, United States
Research Site — Covina, California, United States

Full record on ClinicalTrials.gov

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