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

April 15, 2024 updated by: Eli Lilly and Company

Tirzepatide Study of Renal Function in People With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes: Focus on Kidney Hypoxia in Relation to Fatty Kidney Disease Using Multiparametric Magnetic Resonance Imaging

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Austria
      • Wien, Austria, 1030
        • Recruiting
        • Klinik Landstraße
        • Principal Investigator:
          • Bernhard Ludvik
      • Wien, Austria, 1130
        • Recruiting
        • Klinik Hietzing
        • Principal Investigator:
          • Thomas Stulnig
    • Wien
      • Vienna, Wien, Austria, 1060
        • Recruiting
        • Zentrum für klinische Studien Dr Hanusch Gmbh
        • Principal Investigator:
          • Ursula Hanusch
  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4N 7L3
        • Recruiting
        • LMC Clinical Research Inc. (Barrie)
        • Principal Investigator:
          • Hani Alasaad
      • Concord, Ontario, Canada, L4K 4M2
        • Recruiting
        • LMC Clinical Research Inc. (Thornhill)
        • Principal Investigator:
          • Robert Schlosser
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Toronto General Hospital
        • Principal Investigator:
          • David Cherney
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitair -T
        • Principal Investigator:
          • Andre Carpentier
  • Denmark
    • Hovedstaden
      • Herlev, Hovedstaden, Denmark, 2730
        • Recruiting
        • Steno Diabetes Center - Copenhagen
        • Principal Investigator:
          • Peter Rossing
    • Midtjyllan
      • Aarhus, Midtjyllan, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital, Skejby
        • Principal Investigator:
          • Soren Tang Knudsen
  • Mexico
      • Cuauhtémoc, Mexico, 06700
        • Recruiting
        • Centro de Investigación y Gastroenterología
        • Principal Investigator:
          • Alma Ladron de Guevara Cetina
      • Mexico, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cardiologia Ignacio Chavez
        • Principal Investigator:
          • Jose Salvador Lopez Gil
    • Distrito F
      • Mexico City, Distrito F, Mexico, 14080
        • Not yet recruiting
        • Instituto Nacional de Enfermedades Respiratorias
        • Principal Investigator:
          • Jesús Arturo Rivero Martínez
    • Distrito Federal
      • Ciudad de México, Distrito Federal, Mexico, 03100
        • Recruiting
        • Health Pharma Professional Research S.A. de C.V:
        • Principal Investigator:
          • Angela María Cordoba
      • Mexico City, Distrito Federal, Mexico, 03310
        • Recruiting
        • Grupo Medico Camino Sc
        • Principal Investigator:
          • Jorge Rojas Serrano
      • Mexico City, Distrito Federal, Mexico, 14080
        • Not yet recruiting
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
        • Principal Investigator:
          • Ricardo Correa-Rotter
      • Mexico City, Distrito Federal, Mexico, 06760
        • Recruiting
        • CAIMED México
        • Principal Investigator:
          • Laura Castro Castrezana
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62330
        • Recruiting
        • AGNI Research and Assessment S.C.
        • Principal Investigator:
          • Abel Causor Torres
  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • Recruiting
        • Amsterdam UMC, Locatie VUMC
        • Principal Investigator:
          • Daniel van Raalte
    • Overijssel
      • Almelo, Overijssel, Netherlands, 7609 PP
        • Recruiting
        • Ziekenhuisgroep Twente, locatie Almelo
        • Principal Investigator:
          • Goos Laverman
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Principal Investigator:
          • Petter Bjornstad, MD
      • Denver, Colorado, United States, 80210
        • Recruiting
        • Kidney Associates of Colorado
        • Principal Investigator:
          • Maria Gabriela Velez
    • Indiana
      • Avon, Indiana, United States, 46123
        • Recruiting
        • American Health Network of IN, LLC
        • Principal Investigator:
          • Eric Hewitt
      • Greenfield, Indiana, United States, 46140
        • Recruiting
        • American Health Network of IN, LLC
        • Principal Investigator:
          • Andrew Daluga
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health University Hospital
        • Principal Investigator:
          • Allon Friedman
      • Muncie, Indiana, United States, 47304
        • Recruiting
        • American Health Network of IN, LLC
        • Principal Investigator:
          • Jonathan David Condit
    • Michigan
      • Troy, Michigan, United States, 48098
        • Recruiting
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
        • Principal Investigator:
          • Neil J. Fraser
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Principal Investigator:
          • Nayan Arora
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Medical Research Center - Spokane
        • Principal Investigator:
          • Katherine Tuttle, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered SC
Drug: Placebo
Administered SC
Experimental: Tirzepatide
Tirzepatide administered subcutaneously (SC)
Drug: Tirzepatide
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Kidney Oxygenation in Participants With or Without T2D
Time Frame: Baseline, Week 52
Blood oxygenation-level dependent magnetic resonance imaging (BOLD MRI)
Baseline, Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Kidney Oxygenation in Participants with T2D (BOLD MRI)
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Kidney Oxygenation in Participants without T2D (BOLD MRI)
Time Frame: Baseline, Week 52
Baseline, Week 52
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 52
Baseline, Week 52
Percent Change from Baseline in Renal Sinus Fat Content (MRI)
Time Frame: Baseline, Week 52
Baseline, Week 52
Percent Change from Baseline in Renal Fat Content (MRI Proton Density Fat Fraction)
Time Frame: Baseline, Week 52
Baseline, Week 52
Percent Change from Baseline in Renal Blood Flow (Phase-Contrast MRI)
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Apparent Diffusion Coefficient (ADC) MRI
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Glomerular Filtration Rate (GFR) Iohexol Clearance in Milliliter/Minute/Square Meter (ml/min/m²)
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in 24-hour Urinary Albumin Excretion (UAE) in Milligram/24 Hours (mg/24h)
Time Frame: Baseline, Week 52
Baseline, Week 52
Percent Change from Baseline in Urine Albumin-to-Creatine Ratio (UACR)
Time Frame: Baseline, Week 52
Baseline, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2023

Primary Completion (Estimated)

January 29, 2026

Study Completion (Estimated)

February 26, 2026

Study Registration Dates

First Submitted

September 9, 2022

First Submitted That Met QC Criteria

September 9, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17217
  • I8F-MC-GPIG (Other Identifier: Eli Lilly and Company)
  • 2021-005273-47 (EudraCT Number)
  • 2023-506082-60-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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