Not yet recruitingPhase 4

QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy

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

Lead sponsor

Huijie Zhang

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

Estimated enrollment

820

Study population

Chronic kidney disease, Type 2 diabetes

Eligibility highlights

•BMI ≥24•HbA1c ≤11%•eGFR ≥30•UACR ≥100

Primary endpoint

•Urine Albumin-to-Creatinine Ratio (UACR)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07775846

Org study IDB2026-375R

Timeline

Milestones

Study first posted2026-08-20actual

Last update posted2026-08-20actual

Study start2026-09-01estimated

Primary completion2029-02-28estimated

Study completion2029-06-30estimated

Assets

Investigational agents

Mazdutide

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age ≥18 years, with a confirmed diagnosis of type 2 diabetes mellitus (T2DM).

•Receiving a standard dose of an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) therapy for at least 4 consecutive weeks prior to screening, with the dose expected to remain stable throughout the study period.

•Body Mass Index (BMI) ≥ 24.0 kg/m2.

•Mean urine albumin-to-creatinine ratio (UACR) ≥ 100 mg/g and < 5000 mg/g, calculated from first morning void urine samples collected over 3 consecutive days.

•Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥ 30 mL/min/1.73m2 and ≤ 90 mL/min/1.73m2.

•Serum potassium level ≤ 4.8 mmol/L.

•Glycated hemoglobin (HbA1c) < 11%.

•Voluntarily understood and signed the written Informed Consent Form (ICF).

Exclusion criteria

•Definite diagnosis of non-diabetic kidney disease (e.g., IgA nephropathy, polycystic kidney disease, lupus nephritis, etc).

•Personal or family history of medullary thyroid carcinoma (MTC), or a diagnosis of multiple endocrine neoplasia syndrome type 2 (MEN 2).

•History of severe acute or chronic pancreatitis.

•History of diabetic ketoacidosis (DKA).

•Symptomatic hypotension during the screening period, or a resting systolic blood pressure (SBP) < 110 mmHg.

•Refractory hypertension, defined as a resting SBP > 170 mmHg despite the concurrent use of three antihypertensive medications.

•History of severe dehydration, severe diarrhea, or acute volume depletion within 30 days prior to screening.

•History of acute kidney injury (AKI) within 30 days prior to screening.

•Use of traditional Chinese medicines with potential proteinuria-lowering effects (e.g., Keluoxin capsules, Huangkui capsules, or Shenyan Kangfu tablets) within 30 days prior to screening.

•Use of potassium-sparing diuretics (e.g., triamterene or amiloride) or mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone, or finerenone) within 2 months prior to screening.

•Use of GLP-1 receptor agonists, GLP-1/GIP dual receptor agonists, or GLP-1/glucagon (GCG) dual receptor agonists within 6 months prior to screening.

•Current use of strong CYP3A4 inhibitors (e.g., itraconazole or clarithromycin) or CYP3A4 inducers that may significantly interfere with finerenone metabolism.

•Myocardial infarction, unstable angina, stroke, or hospitalization due to heart failure (NYHA Class III-IV) within 3 months prior to screening.

•Active urogenital tract infection, or a history of urogenital tract infection associated with the prior use of SGLT2 inhibitors.

•Women who are pregnant, planning to become pregnant, or lactating.

•Inability to complete the 6-month follow-up due to general health conditions or geographic relocation.

•Any other condition that, in the opinion of the investigator, renders the participant unsuitable for participation in the study.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Renal / kidney

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Body Weight and Body Mass Index (BMI)

Time frame:Baseline and Month 6

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c) and Fasting Plasma Glucose (FPG)

Time frame:Baseline and Month 6

change from baseline, improvement

Renal / kidney

6 endpoints

Primary/protocol endpoint

Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Month 6

Time frame:Baseline and Month 6

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving UACR Reductions of ≥30% and ≥50%

Time frame:Baseline and Month 6

threshold achievement, improvement

Secondary/protocol endpoint

Regression Rate of Albuminuria Stages

Time frame:Baseline and Month 6

descriptive

Secondary/protocol endpoint

Relative Change From Baseline in UACR at Day 30

Time frame:Baseline and Day 30

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

Time frame:Baseline and Month 6

change from baseline, improvement

Secondary/protocol endpoint

Incidence of Acute Kidney Injury (AKI)

Time frame:Through Month 6

event count, event

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline and Month 6

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Incidence of Adverse Events of Special Interest (AESIs)

Time frame:Through Month 6

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change From Baseline in Serum Potassium Levels

Time frame:Baseline and Month 6

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.