Can a Four-Drug cocktail shield kidneys in diabetes?

NCT ID NCT07775846

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial is testing whether adding two newer medications—finerenone and mazdutide—to a standard two-drug regimen can better protect the kidneys in people with type 2 diabetes and early kidney disease. About 820 adults will be randomly assigned to one of four treatment groups, all receiving a standard ACE inhibitor or ARB, with different combinations of the study drugs. The main goal is to see if the extra drugs reduce urine protein levels, a key marker of kidney damage, more than the standard treatment alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of empagliflozin, finerenone, and mazdutide, added to standard ACE inhibitor or ARB therapy
What this could lead to
If successful, this could establish a more effective drug combination to slow kidney damage in people with type 2 diabetes, potentially reducing the risk of kidney failure.
What could go wrong
The trial is still testing the approach, and results may not confirm added benefit. There are also risks of side effects from combining multiple drugs, such as low blood pressure, high potassium, or gastrointestinal issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 820 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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Contacts and locations

Locations

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 201508, China

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