A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
NCT ID: NCT05536804
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
140 participants
INTERVENTIONAL
2023-02-08
2026-10-31
Brief Summary
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The study will last about 56 weeks and include up to 12 visits.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tirzepatide
Tirzepatide administered subcutaneously (SC)
Tirzepatide
Administered SC
Placebo
Placebo administered SC
Placebo
Administered SC
Interventions
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Tirzepatide
Administered SC
Placebo
Administered SC
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Valley Clinical Trials, Inc.
Northridge, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Kidney Associates of Colorado
Denver, Colorado, United States
American Health Network of Indiana, LLC - Avon
Avon, Indiana, United States
American Health Network of Indiana, LLC - Greenfield
Greenfield, Indiana, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
American Health Network of Indiana, LLC - Muncie
Muncie, Indiana, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
Providence Medical Research Center - Spokane
Spokane, Washington, United States
Klinik Landstraße
Vienna, , Austria
Zentrum für klinische Studien Dr Hanusch Gmbh
Vienna, , Austria
Klinik Hietzing
Vienna, , Austria
LMC Clinical Research Inc. (Barrie)
Barrie, , Canada
LMC Clinical Research Inc. (Thornhill)
Concord, , Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire -T
Sherbrooke, , Canada
Toronto General Hospital
Toronto, , Canada
Fadia El Boreky Medicine
Waterloo, , Canada
Aarhus Universitetshospital, Skejby
Aarhus, , Denmark
Centro de Investigación y Gastroenterología
Cuauhtémoc, , Mexico
Investigación Nefrológica
Cuernavaca, , Mexico
Health Pharma Professional Research S.A. de C.V:
Mexico City, , Mexico
Grupo Medico Camino Sc
Mexico City, , Mexico
Caimed Investigacion En Salud S.A. de C.V.
Mexico City, , Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
México, , Mexico
Ziekenhuisgroep Twente, locatie Almelo
Almelo, , Netherlands
Amsterdam UMC, locatie VUmc
Amsterdam, , Netherlands
Countries
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References
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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 Jun 13. doi: 10.1681/ASN.0000000764. Online ahead of print. No abstract available.
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.
Related Links
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A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes (TREASURE-CKD)
Other Identifiers
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I8F-MC-GPIG
Identifier Type: OTHER
Identifier Source: secondary_id
2021-005273-47
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506082-60-00
Identifier Type: OTHER
Identifier Source: secondary_id
17217
Identifier Type: -
Identifier Source: org_study_id
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