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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-08

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obesity Chronic Kidney Disease Type 2 Diabetes T2D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tirzepatide

Tirzepatide administered subcutaneously (SC)

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Placebo

Placebo administered SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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Tirzepatide

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Kidney Associates of Colorado

Denver, Colorado, United States

Site Status

American Health Network of Indiana, LLC - Avon

Avon, Indiana, United States

Site Status

American Health Network of Indiana, LLC - Greenfield

Greenfield, Indiana, United States

Site Status

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Site Status

American Health Network of Indiana, LLC - Muncie

Muncie, Indiana, United States

Site Status

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

Site Status

University of Washington Medical Center - Montlake

Seattle, Washington, United States

Site Status

Providence Medical Research Center - Spokane

Spokane, Washington, United States

Site Status

Klinik Landstraße

Vienna, , Austria

Site Status

Zentrum für klinische Studien Dr Hanusch Gmbh

Vienna, , Austria

Site Status

Klinik Hietzing

Vienna, , Austria

Site Status

LMC Clinical Research Inc. (Barrie)

Barrie, , Canada

Site Status

LMC Clinical Research Inc. (Thornhill)

Concord, , Canada

Site Status

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

Sherbrooke, , Canada

Site Status

Toronto General Hospital

Toronto, , Canada

Site Status

Fadia El Boreky Medicine

Waterloo, , Canada

Site Status

Aarhus Universitetshospital, Skejby

Aarhus, , Denmark

Site Status

Centro de Investigación y Gastroenterología

Cuauhtémoc, , Mexico

Site Status

Investigación Nefrológica

Cuernavaca, , Mexico

Site Status

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

Mexico City, , Mexico

Site Status

Grupo Medico Camino Sc

Mexico City, , Mexico

Site Status

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

Mexico City, , Mexico

Site Status

Instituto Nacional de Cardiologia Ignacio Chavez

México, , Mexico

Site Status

Ziekenhuisgroep Twente, locatie Almelo

Almelo, , Netherlands

Site Status

Amsterdam UMC, locatie VUmc

Amsterdam, , Netherlands

Site Status

Countries

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United States Austria Canada Denmark Mexico Netherlands

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.

Reference Type DERIVED
PMID: 40512543 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39963952 (View on PubMed)

Related Links

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https://trials.lilly.com/en-US/trial/360461

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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