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

NCT05536804 | Active Not Recruiting Phase 2 FDA Drug

• 4 other identifiers: 17217I8F-MC-GPIG2021-005273-472023-506082-60-00
• Study Type: interventional
• Target: 140
• Locations: 6 countries
• Sites: 27

Brief 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.

Conditions

Overweight; Obesity; Chronic Kidney Disease; Type 2 Diabetes; T2D

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Kidney Oxygenation in Participants With or Without T2D

  Blood oxygenation-level dependent magnetic resonance imaging (BOLD MRI)

  Baseline, Week 52

Secondary Outcomes (10)

• Change from Baseline in Kidney Oxygenation in Participants with T2D (BOLD MRI)

  Baseline, Week 52

• Change from Baseline in Kidney Oxygenation in Participants without T2D (BOLD MRI)

  Baseline, Week 52

• Percent Change from Baseline in Body Weight

  Baseline, Week 52

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

  Baseline, Week 52

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

  Baseline, Week 52

Study Arms (2)

Tirzepatide

EXPERIMENTAL

Tirzepatide administered subcutaneously (SC)

Drug: Tirzepatide

Placebo

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Interventions

Tirzepatide DRUG

Administered SC

Tirzepatide

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (27)

Valley Clinical Trials, Inc.

Northridge, California, 91325, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Kidney Associates of Colorado

Denver, Colorado, 80210, United States

Location

American Health Network of Indiana, LLC - Avon

Avon, Indiana, 46123, United States

Location

American Health Network of Indiana, LLC - Greenfield

Greenfield, Indiana, 46140, United States

Location

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

American Health Network of Indiana, LLC - Muncie

Muncie, Indiana, 47304, United States

Location

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, 48098, United States

Location

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

Location

Providence Medical Research Center - Spokane

Spokane, Washington, 99204, United States

Location

Klinik Landstraße

Vienna, 1030, Austria

Location

Zentrum für klinische Studien Dr Hanusch Gmbh

Vienna, 1060, Austria

Location

Klinik Hietzing

Vienna, 1130, Austria

Location

LMC Clinical Research Inc. (Barrie)

Barrie, L4N 7L3, Canada

Location

LMC Clinical Research Inc. (Thornhill)

Concord, L4K 4M2, Canada

Location

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

Sherbrooke, J1H 5N4, Canada

Location

Toronto General Hospital

Toronto, M5G 2C4, Canada

Location

Fadia El Boreky Medicine

Waterloo, N2J 1C4, Canada

Location

Aarhus Universitetshospital, Skejby

Aarhus, 8200, Denmark

Location

Centro de Investigación y Gastroenterología

Cuauhtémoc, 06700, Mexico

Location

Investigación Nefrológica

Cuernavaca, 62448, Mexico

Location

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

Mexico City, 03100, Mexico

Location

Grupo Medico Camino Sc

Mexico City, 03310, Mexico

Location

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

Mexico City, 06760, Mexico

Location

Instituto Nacional de Cardiologia Ignacio Chavez

México, 14080, Mexico

Location

Ziekenhuisgroep Twente, locatie Almelo

Almelo, 7609 PP, Netherlands

Location

Amsterdam UMC, locatie VUmc

Amsterdam, 1081 HV, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 40512543 DERIVED

• 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.

  PMID: 39963952 DERIVED

Related Links

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

MeSH Terms

Conditions

Overweight; Obesity; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 13, 2022
• Study Start: February 8, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

DK (1); ME (6); AU (3); NL (2); US (10); CA (5)