QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy

What Was Tested

In this phase 4 trial, researchers set out to test Mazdutide.

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.

It had four arms (groups): Group 1 (G1): ARB + empagliflozin + finerenone placebo + mazdutide placebo (experimental), Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide placebo (experimental), Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone placebo (experimental) and Group 4 (G4): ARB + empagliflozin + mazdutide + finerenone (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 820 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥18 years, with a confirmed diagnosis of type 2 diabetes mellitus (T2DM). Body Mass Index (BMI) ≥ 24.0 kg/m2. Voluntarily understood and signed the written Informed Consent Form (ICF).

The full record lists 8 inclusion and 17 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Mazdutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Mazdutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Mazdutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-09-01 with completion listed for 2029-02-28.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Month 6 (time frame: Baseline and Month 6).

It also tracked 10 secondary outcomes, for example Regression Rate of Albuminuria Stages, Relative Change From Baseline in UACR at Day 30, Change From Baseline in Estimated Glomerular Filtration Rate (eGFR), Change From Baseline in Body Weight and Body Mass Index (BMI), Change From Baseline in Hemoglobin A1c (HbA1c) and Fasting Plasma Glucose (FPG) and Change From Baseline in Systolic Blood Pressure (SBP).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Mazdutide in 820 people.

With 820 participants it is a large trial for this field.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Mazdutide compound page, all human trials.