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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

NCT07662213

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Type 2 Diabetes Mellitus

Interventions: Elecoglipron, Semaglutide

Countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, China, Germany

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (201)

Birmingham, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tempe, Arizona, United States
Covina, California, United States
Encinitas, California, United States
Garden Grove, California, United States
Loma Linda, California, United States
Long Beach, California, United States
Pomona, California, United States
Sacramento, California, United States
Bridgeport, Connecticut, United States
Crystal River, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Leesburg, Florida, United States
Orlando, Florida, United States
Lilburn, Georgia, United States
Idaho Falls, Idaho, United States
Melrose Park, Illinois, United States
Evansville, Indiana, United States
Ames, Iowa, United States
Wichita, Kansas, United States
Bowling Green, Kentucky, United States
Rockville, Maryland, United States
Southfield, Michigan, United States
Minneapolis, Minnesota, United States
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
Omaha, Nebraska, United States
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