CClinicalTrials.gg
CompletedNCT05536804TREASURE-CKDUpdated Sep 11, 2026

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

A Phase 2 interventional study of Tirzepatide and Placebo in Overweight, Obesity and Chronic Kidney Disease, sponsored by Eli Lilly and Company. Completed at 27 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Overweight
  • Obesity
  • Chronic Kidney Disease
  • Type 2 Diabetes
  • T2D
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.

This study's enrollment of 134 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
134 participants (actual)

Study arms

  • Experimental
    Tirzepatide

    Tirzepatide administered subcutaneously (SC)

    Drug: Tirzepatide

  • Placebo comparator
    Placebo

    Placebo administered SC

    Drug: Placebo

Interventions

  • DrugTirzepatide

    Administered SC

  • DrugPlacebo

    Administered SC

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline, Week 52

Secondary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 52

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

    Time frame: Baseline, Week 52

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

    Time frame: Baseline, Week 52

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

    Time frame: Baseline, Week 52

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

    Time frame: Baseline, Week 52

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

    Time frame: Baseline, Week 52

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

    Time frame: Baseline, Week 52

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

    Time frame: Baseline, Week 52

07

Study locations

27 sites
  • Valley Clinical Trials, Inc.
    Northridge, California 91325, United States
  • University of Colorado Anschutz Medical Campus
    Aurora, Colorado 80045, United States
  • Kidney Associates of Colorado
    Denver, Colorado 80210, United States
  • American Health Network of Indiana, LLC - Avon
    Avon, Indiana 46123, United States
  • American Health Network of Indiana, LLC - Greenfield
    Greenfield, Indiana 46140, United States
  • Indiana University Health University Hospital
    Indianapolis, Indiana 46202, United States
  • American Health Network of Indiana, LLC - Muncie
    Muncie, Indiana 47304, United States
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
    Troy, Michigan 48098, United States
  • University of Washington Medical Center - Montlake
    Seattle, Washington 98195, United States
  • Providence Medical Research Center - Spokane
    Spokane, Washington 99204, United States
  • Klinik Landstraße
    Vienna, 1030, Austria
  • Zentrum für klinische Studien Dr Hanusch Gmbh
    Vienna, 1060, Austria
  • Klinik Hietzing
    Vienna, 1130, Austria
  • LMC Clinical Research Inc. (Barrie)
    Barrie, L4N 7L3, Canada
  • LMC Clinical Research Inc. (Thornhill)
    Concord, L4K 4M2, Canada
  • Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire -T
    Sherbrooke, J1H 5N4, Canada
  • Toronto General Hospital
    Toronto, M5G 2C4, Canada
  • Fadia El Boreky Medicine
    Waterloo, N2J 1C4, Canada
  • Aarhus Universitetshospital, Skejby
    Aarhus, 8200, Denmark
  • Centro de Investigación y Gastroenterología
    Cuauhtémoc, 06700, Mexico
  • Investigación Nefrológica
    Cuernavaca, 62448, Mexico
  • Health Pharma Professional Research S.A. de C.V:
    Mexico City, 03100, Mexico
  • Grupo Medico Camino Sc
    Mexico City, 03310, Mexico
  • Caimed Investigacion En Salud S.A. de C.V.
    Mexico City, 06760, Mexico
  • Instituto Nacional de Cardiologia Ignacio Chavez
    México, 14080, Mexico
  • Ziekenhuisgroep Twente, locatie Almelo
    Almelo, 7609 PP, Netherlands
  • Amsterdam UMC, locatie VUmc
    Amsterdam, 1081 HV, Netherlands
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05536804
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Sep 13, 2022
Start date
Feb 8, 2023
Primary completion
Jul 6, 2026
Completion
Jul 30, 2026
Last update
Sep 11, 2026

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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