A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus, Type 2 Diabetes With Chronic Kidney Disease

In brief

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron, compared with placebo in adults with type 2 diabetes mellitus (T2DM) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).

Key facts

Study ID

NCT07662135

Run by

AstraZeneca

People needed

900

Starts

2026-07-06

Expected to finish

2028-07-13

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 for at least 90 days prior to screening
• On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s)
• HbA1c value:
• On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
• SGLT2i-naive ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol)
• Impaired renal function
• 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 — Kaohsiung City, Taiwan (enrolling)
• Research Site — Taichung, Taiwan (enrolling)
• Research Site — Zhubei, Taiwan (enrolling)
• Research Site — Nagoya, Japan (enrolling)
• Research Site — Taipei, Taiwan (enrolling)
• Research Site — Blackpool, United Kingdom (enrolling)
• Research Site — Lauderdale Lakes, Florida, United States
• Research Site — Fleming Island, Florida, United States
• Research Site — Concord, California, United States
• Research Site — Orlando, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Braintree, Massachusetts, United States
• Research Site — New Bedford, Massachusetts, United States
• Research Site — Worcester, Massachusetts, United States
• Research Site — Ocoee, Florida, United States
• Research Site — Victorville, California, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — The Bronx, New York, United States
• Research Site — Kinston, North Carolina, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Miami Lakes, Florida, United States

Full record on ClinicalTrials.gov

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