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.
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.
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.
Parallel
Elecoglipron
DrugElicoglipron tablet
Placebo
DrugPlacebo 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
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
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
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
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of all-cause mortality
Time to death from any cause
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