A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease.
Starting soon · Phase 3 · Has a placebo group
Conditions studied: Chronic Kidney Disease
In brief
This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled multicenter study to investigate outcomes with elecoglipron compared with placebo in participants with CKD with and without T2DM who are on background SGLT2i (dapagliflozin) as GDMT and other SoC treatments for CKD.
Key facts
- Study ID
- NCT07753993
- Run by
- AstraZeneca
- People needed
- 7000
- Starts
- 2026-08-28
- Expected to finish
- 2030-10-04
- Last updated by the study team
- 2026-08-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults with confirmed CKD; UACR ≥30 mg/g and eGFR ≥20 mL/min/1.73 m² within specified ranges.
- On stable, patient maximum tolerated, labeled daily dose of ACEI or ARB for ≥4 weeks at least 28 days before screening.
You may not qualify if…
- BMI <23 kg/m² at screening
- History of type 1 diabetes mellitus
- HbA1c ≥10% (86 mmol/mol) at screening
- 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 hypoglycemia unawareness
- Acute coronary syndrome, major cardiac procedure, stroke, or TIA within 3 months prior to screening
- 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
- History/family history (first degree) of medullary thyroid cancer or MEN2
Where it is running
- Research Site — Surprise, Arizona, United States
- Research Site — Chula Vista, California, United States
- Research Site — Waterbury, Connecticut, United States
- Research Site — Chicago, Illinois, United States
- Research Site — Topeka, Kansas, United States
- Research Site — Beltsville, Maryland, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Troy, Michigan, United States
- Research Site — Edina, Minnesota, United States
- Research Site — Saint Paul, Minnesota, United States
- Research Site — Eatontown, New Jersey, United States
- Research Site — Albany, New York, United States
- Research Site — Buffalo, New York, United States
- Research Site — Mineola, New York, United States
- Research Site — Morehead City, North Carolina, United States
- Research Site — Shelby, North Carolina, United States
- Research Site — Statesville, North Carolina, United States
- Research Site — Wilmington, North Carolina, United States
- Research Site — Wilmington, North Carolina, United States
- Research Site — Maumee, Ohio, United States
- Research Site — Rapid City, South Dakota, United States
- Research Site — Knoxville, Tennessee, United States
- Research Site — Morristown, Tennessee, United States
- Research Site — Arlington, Texas, United States
- Research Site — Sheffield, Alabama, United States
Full record on ClinicalTrials.gov
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