A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.

Key facts

Study ID

NCT07662044

Run by

AstraZeneca

People needed

800

Starts

2026-07-06

Expected to finish

2028-07-14

Last updated by the study team

2026-08-04

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
• HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
• 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, 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 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 (New York Heart Association IV)
• History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

Where it is running

• Research Site — Taichung, Taiwan (enrolling)
• Research Site — Taichung, Taiwan (enrolling)
• Research Site — Kaohsiung City, Taiwan (enrolling)
• Research Site — Shinjuku-ku, Japan (enrolling)
• Research Site — Walnut Creek, California, United States
• Research Site — Englewood, Colorado, United States
• Research Site — Lomita, California, United States
• Research Site — Orlando, Florida, United States
• Research Site — San Diego, California, United States
• Research Site — Conyers, Georgia, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Hinesville, Georgia, United States
• Research Site — El Dorado, Kansas, United States
• Research Site — Newton, Kansas, United States
• Research Site — Bowie, Maryland, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Mandeville, Louisiana, United States
• Research Site — Southfield, Michigan, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Anderson, South Carolina, United States
• Research Site — Knoxville, Tennessee, United States
• Research Site — Fort Worth, Texas, United States
• Research Site — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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