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OverweightPhase 2TREASURE-CKDNCT05536804

A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

A Phase 2 study testing Tirzepatide in people with Overweight and Obesity, run by Eli Lilly and Company at 27 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

We are doing this study to learn more about how tirzepatide may help fight chronic kidney disease in people with obesity with or without type 2 diabetes (T2D). The study will last about 56 weeks and include up to 12 visits. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overweight, Obesity, Chronic Kidney Disease
What is being tested?
Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
134 participants
Where
27 sitesin 6 countries
Study dates
8 Feb 2023to 30 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

27 sites in 6 countries.

27 sites in 6 countries

United States10 sites

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • American Health Network of Indiana, LLC - Avon

    Avon, Indiana, 46123

  • Kidney Associates of Colorado

    Denver, Colorado, 80210

  • American Health Network of Indiana, LLC - Greenfield

    Greenfield, Indiana, 46140

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202

  • American Health Network of Indiana, LLC - Muncie

    Muncie, Indiana, 47304

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

  • Providence Medical Research Center - Spokane

    Spokane, Washington, 99204

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

Other trials in United States

Mexico6 sites

  • Centro de Investigación y Gastroenterología

    Cuauhtémoc, 06700

  • Investigación Nefrológica

    Cuernavaca, 62448

  • Instituto Nacional de Cardiologia Ignacio Chavez

    México, 14080

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

    Mexico City, 03100

  • Grupo Medico Camino Sc

    Mexico City, 03310

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

    Mexico City, 06760

Other trials in Mexico

Canada5 sites

  • LMC Clinical Research Inc. (Barrie)

    Barrie, L4N 7L3

  • LMC Clinical Research Inc. (Thornhill)

    Concord, L4K 4M2

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

    Sherbrooke, J1H 5N4

  • Toronto General Hospital

    Toronto, M5G 2C4

  • Fadia El Boreky Medicine

    Waterloo, N2J 1C4

Other trials in Canada

Austria3 sites

  • Klinik Landstraße

    Vienna, 1030

  • Zentrum für klinische Studien Dr Hanusch Gmbh

    Vienna, 1060

  • Klinik Hietzing

    Vienna, 1130

Other trials in Austria

Netherlands2 sites

  • Ziekenhuisgroep Twente, locatie Almelo

    Almelo, 7609 PP

  • Amsterdam UMC, locatie VUmc

    Amsterdam, 1081 HV

Other trials in Netherlands

Denmark1 site

  • Aarhus Universitetshospital, Skejby

    Aarhus, 8200

Other trials in Denmark

About this study

Official title: Tirzepatide Study of Renal Function in People With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes: Focus on Kidney Hypoxia in Relation to Fatty Kidney Disease Using Multiparametric Magnetic Resonance Imaging

We are doing this study to learn more about how tirzepatide may help fight chronic kidney disease in people with obesity with or without type 2 diabetes (T2D).

The study will last about 56 weeks and include up to 12 visits.

Being tested
Tirzepatide, Placebo
Medical subject headings
Overweight, Obesity, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT05536804
Study groupRoleWhat they receive
TirzepatideExperimentalTirzepatide administered subcutaneously (SC)
Receives: Drug: Tirzepatide
PlaceboPlacebo comparatorPlacebo administered SC
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change from Baseline in Renal Sinus Fat Content (MRI)

    Measured: Baseline, Week 52

Secondary outcomes (8)

  1. Percent Change from Baseline in Body Weight

    Measured: Baseline, Week 52

  2. Percent Change from Baseline in Renal Fat Content (MRI Proton Density Fat Fraction)

    Measured: Baseline, Week 52

  3. Percent Change from Baseline in Renal Blood Flow (Phase-Contrast MRI)

    Measured: Baseline, Week 52

  4. Change from Baseline in Apparent Diffusion Coefficient (ADC) MRI

    Measured: Baseline, Week 52

  5. Change from Baseline in Glomerular Filtration Rate (GFR) Iohexol Clearance in Milliliter/Minute/Square Meter (ml/min/m²)

    Measured: Baseline, Week 52

  6. Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)

    Measured: Baseline, Week 52

  7. Change from Baseline in 24-hour Urinary Albumin Excretion (UAE) in Milligram/24 Hours (mg/24h)

    Measured: Baseline, Week 52

  8. Percent Change from Baseline in Urine Albumin-to-Creatine Ratio (UACR) in Participants With Baseline ≥30 mg/g

    Measured: Baseline, Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2022
  2. Study start8 Feb 2023
  3. Primary completion6 Jul 2026
  4. Study completion30 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05536804
Sponsor's protocol ID
17217
Other IDs
I8F-MC-GPIG, 2021-005273-47, 2023-506082-60-00, 2023
Acronym
TREASURE-CKD
Status last verified
Sep 2026
First submitted
9 Sep 2022
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Heerspink HJL, Friedman AN, Bjornstad P, van Raalte DH, Cherney D, Cao D, Garcia-Perez LE, Stefanski A, Turfanda I, Bunck MC, Benabbad I, Griffin R, Piras de Oliveira C. Kidney Parameters with Tirzepatide in Obesity with or without Type 2 Diabetes. J Am Soc Nephrol. 2025 Nov 1;36(11):2190-2200. doi: 10.1681/ASN.0000000764. Epub 2025 Jun 13.

    PubMed 40512543

  • Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

    PubMed 39963952

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tirzepatide in people with Overweight and Obesity, run by Eli Lilly and Company at 27 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Mexico, Canada, Austria, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change from Baseline in Renal Sinus Fat Content (MRI) (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05536804, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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