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 · NCT07662213 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial 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 take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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 is running

60 locations listed across 30 US states.

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 - Covina, California, United States
Research Site - Encinitas, California, United States
Research Site - Garden Grove, California, United States
Research Site - Loma Linda, California, United States
Research Site - Long Beach, California, United States
Research Site - Pomona, California, United States
Research Site - Sacramento, California, United States
Research Site - Bridgeport, Connecticut, United States
Research Site - Crystal River, Florida, United States
Research Site - Hollywood, Florida, United States
Research Site - Jacksonville, Florida, United States
Research Site - Lake City, Florida, United States
Research Site - Leesburg, Florida, United States
Research Site - Orlando, Florida, United States
Research Site - Lilburn, Georgia, United States
Research Site - Idaho Falls, Idaho, United States
Research Site - Melrose Park, Illinois, United States
Research Site - Evansville, Indiana, 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 - Southfield, Michigan, United States
Research Site - Minneapolis, Minnesota, United States
Research Site - Jefferson City, Missouri, United States
Research Site - Kansas City, Missouri, United States
Research Site - Omaha, Nebraska, United States
Research Site - Henderson, Nevada, United States
Research Site - Las Vegas, Nevada, United States
Research Site - Albuquerque, New Mexico, United States
Research Site - Durham, North Carolina, United States
Research Site - Morehead City, North Carolina, United States
Research Site - Raleigh, North Carolina, United States
Research Site - Statesville, North Carolina, United States
Research Site - Wilmington, North Carolina, United States
Research Site - Columbus, Ohio, United States
Research Site - Oklahoma City, Oklahoma, United States
Research Site - Feasterville-Trevose, Pennsylvania, United States
Research Site - Philadelphia, Pennsylvania, United States
Research Site - Myrtle Beach, South Carolina, United States
Research Site - North Charleston, South Carolina, United States
Research Site - Memphis, Tennessee, United States
Research Site - Morristown, Tennessee, United States
Research Site - Dallas, Texas, United States
Research Site - Houston, Texas, United States
Research Site - Houston, Texas, United States
Research Site - Houston, Texas, United States
Research Site - Katy, Texas, United States
Research Site - San Antonio, Texas, United States
Research Site - San Antonio, Texas, United States
Research Site - Sugar Land, Texas, United States
Research Site - Weslaco, Texas, United States
Research Site - Bountiful, Utah, United States
Research Site - Salt Lake City, Utah, United States
Research Site - Leesburg, Virginia, United States
Research Site - Norfolk, Virginia, United States

Showing 60 of 209 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →