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

What this 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).

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• Research Site, Birmingham, Alabama, United States
• Research Site, Mesa, Arizona, United States
• Research Site, Phoenix, Arizona, United States
• Research Site, Tempe, Arizona, United States
• Research Site, Encinitas, California, United States
• Research Site, Garden Grove, California, United States
• Research Site, Lincoln, California, United States
• Research Site, Loma Linda, California, United States
• Research Site, Pomona, California, United States
• Research Site, Crystal River, Florida, United States
• Research Site, Hollywood, Florida, United States
• Research Site, Jacksonville, Florida, United States

+ 146 more sites.

Who to contact

AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07662213.