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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Elecoglipron
  • Placebo

Treatment groups

7,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators