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

Last updated: April 16, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes And Hypertension

Obesity

Diabetes Prevention

Treatment

Placebo

Tirzepatide

Clinical Study ID

NCT05536804
17217
I8F-MC-GPIG
2021-005273-47
2023-506082-60-00
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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) >30milligram/gram (mg/g)

  • Have been receiving an angiotensin-converting enzyme (ACE) or angiotensin IIreceptor blockers (ARB) that is considered the maximal appropriate dose by theinvestigator for treatment of chronic kidney disease or hypertension (unless theparticipant 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

Exclusion Criteria:

All participants:

  • Have a self-reported change in body weight >5 kilogram (kg) within 90 days prior toscreening.

  • Have a prior or planned surgical treatment for obesity

  • Have or plan to have endoscopic and/or device-based therapy for obesity or have haddevice removal within the last 180 days

  • Have eGFR <25 mL/min/1.73m² calculated by using creatinine-based chronic kidneydisease epidemiology collaboration (CKD-EPI) equations, as determined by centrallaboratory at screening.

  • Have a history of unstable or rapidly progressing renal disease according toinvestigator judgment

  • Have a known clinically significant gastric emptying abnormality (for example,severe diabetic gastroparesis or gastric outlet obstruction) or chronically takedrugs 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 ornon-proliferative diabetic retinopathy that requires acute treatment.

  • Have been diagnosed with type 1 diabetes (T1D) or have history of ketoacidosis orhyperosmolar state/coma

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 08, 2023
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Zentrum für klinische Studien Dr Hanusch Gmbh

    Vienna, Wien 1060
    Austria

    Active - Recruiting

  • Karl Landsteiner Institute for Metabolic Disease and Nephrology

    Wien, 1130
    Austria

    Active - Recruiting

  • Klinik Hietzing

    Wien, 1130
    Austria

    Active - Recruiting

  • Klinik Landstraße

    Wien, 1030
    Austria

    Active - Recruiting

  • Krankenhaus Hietzing

    Wien, 1130
    Austria

    Active - Recruiting

  • LMC Clinical Research Inc. (Barrie)

    Barrie, Ontario L4N 7L3
    Canada

    Active - Recruiting

  • LMC Clinical Research Inc. (Thornhill)

    Concord, Ontario L4K 4M2
    Canada

    Active - Recruiting

  • Renal Physiology Laboratory

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

  • Fadia El Boreky Medicine

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Centre de recherche du CHUS

    Sherbrooke, Quebec J1H 5N4
    Canada

    Active - Recruiting

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

    Sherbrooke, Quebec J1H 5N4
    Canada

    Active - Recruiting

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

    Sherbrooke, Quebec J1H 5N4
    Canada

    Active - Recruiting

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de lEstrie-CHUS)

    Sherbrooke, Quebec J1H 5N4
    Canada

    Active - Recruiting

  • Steno Diabetes Center

    Gentofte, Hovedstaden 2820
    Denmark

    Site Not Available

  • Steno Diabetes Center - Copenhagen

    Herlev, Hovedstaden 2730
    Denmark

    Site Not Available

  • Aarhus Universitetshospital, Skejby

    Aarhus, Midtjylland 8200
    Denmark

    Active - Recruiting

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

    Ciudad de México, Distrito Federal 03100
    Mexico

    Active - Recruiting

  • CAIMED México

    Mexico City, Distrito Federal 06760
    Mexico

    Active - Recruiting

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

    Mexico City, Distrito Federal 06760
    Mexico

    Active - Recruiting

  • Grupo Medico Camino Sc

    Mexico City, Distrito Federal 03310
    Mexico

    Active - Recruiting

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, Distrito Federal 14080
    Mexico

    Site Not Available

  • Instituto Nacional de Enfermedades Respiratorias

    Mexico City, Distrito Federal 14080
    Mexico

    Site Not Available

  • AGNI Research and Assessment S.C.

    Cuernavaca, Morelos 62330
    Mexico

    Active - Recruiting

  • Investigación Nefrológica

    Cuernavaca, Morelos 62448
    Mexico

    Site Not Available

  • Centro de Investigación y Gastroenterología

    Cuauhtémoc, 06700
    Mexico

    Active - Recruiting

  • Instituto Nacional de Cardiologia Ignacio Chavez

    Mexico, 14080
    Mexico

    Active - Recruiting

  • Amsterdam UMC, locatie VUmc

    Amsterdam, Noord-Holland 1081 HV
    Netherlands

    Active - Recruiting

  • Ziekenhuisgroep Twente, locatie Almelo

    Almelo, Overijssel 7609 PP
    Netherlands

    Active - Recruiting

  • Valley Clinical Trials, Inc.

    Northridge, California 91325
    United States

    Active - Recruiting

  • Clinical Translational Research Center (CTRC)

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Kidney Associates of Colorado

    Denver, Colorado 80210
    United States

    Active - Recruiting

  • American Health Network of IN, LLC

    Avon, Indiana 46123
    United States

    Active - Recruiting

  • American Health Network of Indiana, LLC - Avon

    Avon, Indiana 46123
    United States

    Active - Recruiting

  • American Health Network of IN, LLC

    Greenfield, Indiana 46140
    United States

    Site Not Available

  • American Health Network of Indiana, LLC - Greenfield

    Greenfield, Indiana 46140
    United States

    Active - Recruiting

  • Indiana University Health University Hospital

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • American Health Network of IN, LLC

    Muncie, Indiana 47304
    United States

    Site Not Available

  • American Health Network of Indiana, LLC - Muncie

    Muncie, Indiana 47304
    United States

    Active - Recruiting

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan 48098
    United States

    Active - Recruiting

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Active - Recruiting

  • University of Washington Medical Center - Montlake

    Seattle, Washington 98195
    United States

    Active - Recruiting

  • Providence Medical Research Center - Spokane

    Spokane, Washington 99204
    United States

    Active - Recruiting

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