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NCT07775846 · ClinicalTrials.gov record · last posted 2026-08-20

QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy

StatusNot Yet Recruiting
PhasePhase 4
Started2026-09-01
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from the ClinicalTrials.gov record
This study employs a prospective, randomized, double-blind, parallel-controlled design, aiming to enroll adult participants with type 2 diabetic kidney disease (DKD) who meet the eligibility criteria. With an angiotensin receptor blocker (ARB) as the background therapy, all participants will be randomized in a 1:1:1:1 ratio into four treatment groups: Group 1 (G1): ARB + empagliflozin + finerenone placebo + mazdutide placebo; Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide placebo; Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone placebo; Group 4 (G4): ARB + empagliflozin + mazdutide + finerenone. The primary comparisons include G2 vs. G1, G3 vs. G1, G4 vs. G2, and G4 vs. G3, designed to evaluate the superiority of triple therapy over dual therapy, and quadruple therapy over triple therapy, in reducing the urine albumin-to-creatinine ratio (UACR).
Trial Details
NCT Number NCT07775846
Lead Sponsor Huijie Zhang
Conditions Type 2 Diabetic Kidney Disease
Enrollment 820 participants
Start Date 2026-09-01
Primary Completion 2029-02-28 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-20