A Phase 3 interventional study of Elecoglipron and Placebo in Chronic Kidney Disease, sponsored by AstraZeneca. Recruiting at 715 sites in 37 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
Elecoglipron tablet once daily
Drug: Elecoglipron
Placebo matching Elecoglipron tablet once daily
Drug: Placebo
Elicoglipron tablet
Placebo tablet
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
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
Time frame: Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or CV and renal death
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 * CV and renal death
Time frame: Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of composite of all-cause mortality, MI, or stroke
Time to the first occurrence of any component of this composite: * All-cause mortality * MI * Stroke
Time frame: Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of MACE (CV death, MI, or stroke)
Time to the first occurrence of any component of this composite: * CV and renal death * MI * Stroke
Time frame: Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of all-cause mortality
Time to death from any cause
Time frame: Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death
Time to death from CV cause
Time frame: Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the pure renal composite of ≥ 50% sustained decline in eGFR, ESKD, or renal death
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 * Renal death
Time frame: Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HF hospitalizations
Time to the first occurrence of any component of this composite: * CV death * HF hospitalizations (hHF)
Time frame: Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite endpoint of CV death, MI, stroke, or HF hospitalizations
Time to first occurrence of any component of this composite: * CV death * MI * Stroke * HF hospitalizations (hHF)
Time frame: Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of all-cause hospitalization
Time to hospitalization for any cause
Time frame: Event-driven, trial is estimated to be up to 4.5 years
Showing the first 100 of 715 sites across 37 countries.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Sap
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