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NOT YET RECRUITING
NCT07775846
PHASE4

QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy

Sponsor: Huijie Zhang

View on ClinicalTrials.gov

Summary

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).

Official title: QUAdruple Therapy With RASi, Empagliflozin, Finerenone, and Mazdutide in Type 2 Diabetes and Early Treatment of Nephropathy(QUARTET-DKD)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

820

Start Date

2026-09-01

Completion Date

2029-06-30

Last Updated

2026-08-20

Healthy Volunteers

No

Interventions

DRUG

empagliflozin

Oral tablet, administered at a fixed dose of 10 mg once daily for 6 months.

DRUG

Finerenone

Oral tablet, taken once daily for 6 months. Initial dose is 10 mg or 20 mg once daily adjusted based on baseline eGFR (20 mg for eGFR \>= 60 mL/min/1.73m²; 10 mg for eGFR 30-60 mL/min/1.73m²). Subsequent dose adjustments are guided by serum potassium levels and renal function.

DRUG

Mazdutide

Once-weekly subcutaneous injection for 6 months, following a mandatory dose-escalation schedule: initiated at 2 mg once weekly for 4 weeks, up-titrated to 4 mg once weekly for 4 weeks (if tolerated), and further increased to 6 mg once weekly as the target maintenance dose.

DRUG

Finerenone Placebo

Oral tablet matching active finerenone in appearance and scheduling, without active ingredients, taken once daily for 6 months.

DRUG

Mazdutide Placebo

Once-weekly subcutaneous injection matching active mazdutide in appearance and scheduling, without active ingredients, for 6 months.

DRUG

Angiotensin Receptor Blocker (ARB)

Standard background therapy, titrated to a stable dose for at least 4 weeks prior to enrollment and maintained throughout the 6-month study period.

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China