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Could a diabetes drug protect kidneys in obesity? new trial investigates

NCT ID NCT05536804

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This Phase 2 trial tests whether tirzepatide, a drug already used for diabetes and weight loss, can improve kidney health in 140 people with obesity and chronic kidney disease (with or without type 2 diabetes). Researchers will use MRI scans to measure changes in kidney fat and blood flow over about 56 weeks. The goal is to see if tirzepatide can reduce kidney fat and improve function, potentially offering a new way to manage kidney disease in this population.

What this could mean

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

Active substance
Tirzepatide
What this could lead to
If successful, this could point toward a new treatment option for chronic kidney disease in people with obesity, potentially slowing kidney decline.
What could go wrong
This is an early Phase 2 trial with only 140 participants, so results may not apply to everyone. The main focus is on MRI changes, not long-term kidney outcomes, and tirzepatide may cause side effects like nausea or vomiting.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

134 people

The number who actually took part.

Started

Feb 2023

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: All participants with or without diabetes: * Have a Body Mass Index (BMI) ≥27 kilogram/square meter (kg/m²) at screening * Diagnosed with chronic kidney disease (CKD) * Has an estimated glomerular filtration rate (eGFR) ≥25 to ≤60 ml/min/1.73 m² or eGFR ≥25 to ≤75 ml/min/1.73 m² if urine albumin-to-creatinine ratio (UACR) \>30 milligram/gram (mg/g) * Have been receiving an angiotensin-converting enzyme (ACE) or angiotensin II receptor blockers (ARB) that is considered the maximal appropriate dose by the investigator for treatment of chronic kidney disease or hypertension (unless the participant has low blood pressure or hypotension) Participants without diabetes: * Have Hemoglobin A1c (HbA1c) \<6.5% at screening Participants with Type 2 diabetes: * Have been diagnosed at least 180 days prior to screening * Have HbA1c ≤9.5% at screening Exclusion Criteria: All participants: * Have a self-reported change in body weight \>5 kilogram (kg) within 90 days prior to screening. * Have a prior or planned surgical treatment for obesity * Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 180 days * Have eGFR \<25 mL/min/1.73m² calculated by using creatinine-based chronic kidney disease epidemiology collaboration (CKD-EPI) equations, as determined by central laboratory at screening. * Have a history of unstable or rapidly progressing renal disease according to investigator judgment * Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility) * Have had a history of chronic or acute pancreatitis Participants with T2D: * Have history of proliferative diabetic retinopathy or diabetic macular edema or non-proliferative diabetic retinopathy that requires acute treatment. * Have been diagnosed with type 1 diabetes (T1D) or have history of ketoacidosis or hyperosmolar state/coma

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome Obesity obesity disorder Overweight type 2 diabetes mellitus

As listed by the trial registrant

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

Chronic kidney disease Obesity Overweight T2D Type 2 diabetes

Contacts and locations

Locations

  • Aarhus Universitetshospital, Skejby

    Aarhus, 8200, Denmark

  • American Health Network of Indiana, LLC - Avon

    Avon, Indiana, 46123, United States

  • American Health Network of Indiana, LLC - Greenfield

    Greenfield, Indiana, 46140, United States

  • American Health Network of Indiana, LLC - Muncie

    Muncie, Indiana, 47304, United States

  • Amsterdam UMC, locatie VUmc

    Amsterdam, 1081 HV, Netherlands

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098, United States

  • Caimed Investigacion En Salud S.A. de C.V.

    Mexico City, 06760, Mexico

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire -T

    Sherbrooke, J1H 5N4, Canada

  • Centro de Investigación y Gastroenterología

    Cuauhtémoc, 06700, Mexico

  • Fadia El Boreky Medicine

    Waterloo, N2J 1C4, Canada

  • Grupo Medico Camino Sc

    Mexico City, 03310, Mexico

  • Health Pharma Professional Research S.A. de C.V:

    Mexico City, 03100, Mexico

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202, United States

  • Instituto Nacional de Cardiologia Ignacio Chavez

    México, 14080, Mexico

  • Investigación Nefrológica

    Cuernavaca, 62448, Mexico

  • Kidney Associates of Colorado

    Denver, Colorado, 80210, United States

  • Klinik Hietzing

    Vienna, 1130, Austria

  • Klinik Landstraße

    Vienna, 1030, Austria

  • LMC Clinical Research Inc. (Barrie)

    Barrie, L4N 7L3, Canada

  • LMC Clinical Research Inc. (Thornhill)

    Concord, L4K 4M2, Canada

  • Providence Medical Research Center - Spokane

    Spokane, Washington, 99204, United States

  • Toronto General Hospital

    Toronto, M5G 2C4, Canada

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195, United States

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325, United States

  • Zentrum für klinische Studien Dr Hanusch Gmbh

    Vienna, 1060, Austria

  • Ziekenhuisgroep Twente, locatie Almelo

    Almelo, 7609 PP, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.