A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease.

NCT07753993 · tracked via the Priya Life Science UK tracker

Sponsor

AstraZeneca

Phase

Phase 3

Started

2026-08-21

Last updated

2026-09-09

Condition(s) studied

Chronic Kidney Disease

Investigational drug(s) / intervention(s)

ElecoglipronPlacebo

Elecoglipron: Elicoglipron tablet

Placebo: Placebo tablet

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or all-cause mortality — Event-driven, trial is estimated to be up to 4.5 years
Time to the first occurrence of any component of this composite: * ≥ 50% sustained decline in eGFR * ESKD defined as sustained eGFR \< 10 mL/min/1.73 m2, or Chronic dialysis treatment, or Receiving a renal transplant * All-cause mortality

Trial sites (715)

Facility	City	Region	Status
Research Site	Huntsville	Alabama	Not Yet Recruiting
Research Site	Montgomery	Alabama	Not Yet Recruiting
Research Site	Sheffield	Alabama	Not Yet Recruiting
Research Site	Peoria	Arizona	Not Yet Recruiting
Research Site	Phoenix	Arizona	Not Yet Recruiting
Research Site	Surprise	Arizona	Not Yet Recruiting
Research Site	Little Rock	Arkansas	Withdrawn
Research Site	Chula Vista	California	Not Yet Recruiting
Research Site	Concord	California	Not Yet Recruiting
Research Site	Daly City	California	Not Yet Recruiting
Research Site	Fremont	California	Not Yet Recruiting
Research Site	Huntington Beach	California	Not Yet Recruiting
Research Site	Huntington Park	California	Not Yet Recruiting
Research Site	Lomita	California	Not Yet Recruiting
Research Site	National City	California	Not Yet Recruiting
Research Site	Northridge	California	Not Yet Recruiting
Research Site	Northridge	California	Not Yet Recruiting
Research Site	Rolling Hills Estates	California	Withdrawn
Research Site	San Diego	California	Not Yet Recruiting
Research Site	San Francisco	California	Withdrawn
Research Site	San Mateo	California	Not Yet Recruiting
Research Site	Tarzana	California	Not Yet Recruiting
Research Site	Arvada	Colorado	Not Yet Recruiting
Research Site	Denver	Colorado	Not Yet Recruiting
Research Site	Hartford	Connecticut	Not Yet Recruiting
Research Site	Middlebury	Connecticut	Not Yet Recruiting
Research Site	Waterbury	Connecticut	Not Yet Recruiting
Research Site	Boca Raton	Florida	Not Yet Recruiting
Research Site	Boynton Beach	Florida	Not Yet Recruiting
Research Site	Cutler Bay	Florida	Not Yet Recruiting
Research Site	Fort Lauderdale	Florida	Not Yet Recruiting
Research Site	Hollywood	Florida	Not Yet Recruiting
Research Site	Jacksonville Beach	Florida	Not Yet Recruiting
Research Site	Jensen Beach	Florida	Not Yet Recruiting
Research Site	Lauderdale Lakes	Florida	Not Yet Recruiting
Research Site	Longwood	Florida	Not Yet Recruiting
Research Site	Melbourne	Florida	Not Yet Recruiting
Research Site	Miami	Florida	Not Yet Recruiting
Research Site	Miami	Florida	Not Yet Recruiting
Research Site	Ocoee	Florida	Not Yet Recruiting

+ 675 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07753993 on ClinicalTrials.gov ↗ ← All trials in the UK