Back to resultsA Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes (TREASURE-CKD)
Primary Purpose
Overweight, Obesity, Chronic Kidney Disease
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tirzepatide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overweight
Eligibility Criteria
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) ≥30 to ≤60 ml/min/1.73 m² or eGFR ≥30 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 ≥7.0% to ≤10.5% 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 <30 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
Sites / Locations
- University of Colorado Anschutz Medical CampusRecruiting
- Kidney Associates of ColoradoRecruiting
- American Health Network of IN, LLCRecruiting
- American Health Network of IN, LLCRecruiting
- Indiana University Health University HospitalRecruiting
- American Health Network of IN, LLCRecruiting
- Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionRecruiting
- University of Washington Medical CenterRecruiting
- Providence Medical Research Center - SpokaneRecruiting
- Zentrum für klinische Studien Dr Hanusch GmbhRecruiting
- Klinik LandstraßeRecruiting
- LMC Clinical Research Inc. (Barrie)Recruiting
- LMC Clinical Research Inc. (Thornhill)Recruiting
- Toronto General HospitalRecruiting
- Centre de recherche du CHUSRecruiting
- Steno Diabetes Center - CopenhagenRecruiting
- Aarhus Universitetshospital, SkejbyRecruiting
- Health Pharma Professional Research S.A. de C.V:Recruiting
- Grupo Medico Camino ScRecruiting
- CAIMED MéxicoRecruiting
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Instituto Nacional de Enfermedades Respiratorias
- AGNI Research and Assessment S.C.Recruiting
- Centro de Investigación y GastroenterologíaRecruiting
- Instituto Nacional de Cardiologia Ignacio ChavezRecruiting
- Amsterdam UMC, locatie VUmcRecruiting
- Ziekenhuisgroep Twente, locatie AlmeloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tirzepatide
Placebo
Arm Description
Tirzepatide administered subcutaneously (SC)
Placebo administered SC
Outcomes
Primary Outcome Measures
Change from Baseline in Kidney Oxygenation in Participants With or Without T2D
Blood oxygenation-level dependent magnetic resonance imaging (BOLD MRI)
Secondary Outcome Measures
Change from Baseline in Kidney Oxygenation in Participants with T2D (BOLD MRI)
Change from Baseline in Kidney Oxygenation in Participants without T2D (BOLD MRI)
Percent Change from Baseline in Body Weight
Percent Change from Baseline in Renal Sinus Fat Content (MRI)
Percent Change from Baseline in Renal Fat Content (MRI Proton Density Fat Fraction)
Percent Change from Baseline in Renal Blood Flow (Phase-Contrast MRI)
Change from Baseline in Apparent Diffusion Coefficient (ADC) MRI
Change from Baseline in Glomerular Filtration Rate (GFR) Iohexol Clearance in Milliliter/Minute/Square Meter (ml/min/m²)
Change from Baseline in 24-hour Urinary Albumin Excretion (UAE) in Milligram/24 Hours (mg/24h)
Percent Change from Baseline in Urine Albumin-to-Creatine Ratio (UACR)
Full Information
NCT ID
NCT05536804
First Posted
September 9, 2022
Last Updated
October 16, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT05536804
Brief Title
A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
Acronym
TREASURE-CKD
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
January 29, 2026 (Anticipated)
Study Completion Date
February 26, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Chronic Kidney Disease, Type 2 Diabetes, T2D
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tirzepatide
Arm Type
Experimental
Arm Description
Tirzepatide administered subcutaneously (SC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change from Baseline in Kidney Oxygenation in Participants With or Without T2D
Description
Blood oxygenation-level dependent magnetic resonance imaging (BOLD MRI)
Time Frame
Baseline, Week 52
Secondary Outcome Measure Information:
Title
Change from Baseline in Kidney Oxygenation in Participants with T2D (BOLD MRI)
Time Frame
Baseline, Week 52
Title
Change from Baseline in Kidney Oxygenation in Participants without T2D (BOLD MRI)
Time Frame
Baseline, Week 52
Title
Percent Change from Baseline in Body Weight
Time Frame
Baseline, Week 52
Title
Percent Change from Baseline in Renal Sinus Fat Content (MRI)
Time Frame
Baseline, Week 52
Title
Percent Change from Baseline in Renal Fat Content (MRI Proton Density Fat Fraction)
Time Frame
Baseline, Week 52
Title
Percent Change from Baseline in Renal Blood Flow (Phase-Contrast MRI)
Time Frame
Baseline, Week 52
Title
Change from Baseline in Apparent Diffusion Coefficient (ADC) MRI
Time Frame
Baseline, Week 52
Title
Change from Baseline in Glomerular Filtration Rate (GFR) Iohexol Clearance in Milliliter/Minute/Square Meter (ml/min/m²)
Time Frame
Baseline, Week 52
Title
Change from Baseline in 24-hour Urinary Albumin Excretion (UAE) in Milligram/24 Hours (mg/24h)
Time Frame
Baseline, Week 52
Title
Percent Change from Baseline in Urine Albumin-to-Creatine Ratio (UACR)
Time Frame
Baseline, Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) ≥30 to ≤60 ml/min/1.73 m² or eGFR ≥30 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 ≥7.0% to ≤10.5% 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 <30 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petter Bjornstad, MD
Facility Name
Kidney Associates of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Gabriela Velez
Facility Name
American Health Network of IN, LLC
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
317-718-5479
First Name & Middle Initial & Last Name & Degree
Eric Hewitt
Facility Name
American Health Network of IN, LLC
City
Greenfield
State/Province
Indiana
ZIP/Postal Code
46140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Daluga
Facility Name
Indiana University Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allon Allon Friedman
Facility Name
American Health Network of IN, LLC
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan David Condit
Facility Name
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
248-312-0025
First Name & Middle Initial & Last Name & Degree
Neil J. Fraser
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nayan Arora
Facility Name
Providence Medical Research Center - Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Tuttle, MD
Facility Name
Zentrum für klinische Studien Dr Hanusch Gmbh
City
Vienna
State/Province
Wien
ZIP/Postal Code
1060
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
Phone
0436505150091
First Name & Middle Initial & Last Name & Degree
Ursula Hanusch
Facility Name
Klinik Landstraße
City
Wien
ZIP/Postal Code
1030
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhard Ludvik
Facility Name
LMC Clinical Research Inc. (Barrie)
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4N 7L3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
7057370830
First Name & Middle Initial & Last Name & Degree
Hani Alasaad
Facility Name
LMC Clinical Research Inc. (Thornhill)
City
Concord
State/Province
Ontario
ZIP/Postal Code
L4K 4M2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
9057638660
First Name & Middle Initial & Last Name & Degree
Robert Schlosser
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Cherney
Facility Name
Centre de recherche du CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Carpentier
Facility Name
Steno Diabetes Center - Copenhagen
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
Phone
4530913383
First Name & Middle Initial & Last Name & Degree
Peter Rossing
Facility Name
Aarhus Universitetshospital, Skejby
City
Aarhus
State/Province
Midtjyllan
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soren Tang Knudsen
Facility Name
Health Pharma Professional Research S.A. de C.V:
City
Ciudad de México
State/Province
Distrito Federal
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
525575864856
First Name & Middle Initial & Last Name & Degree
Angela María Cordoba
Facility Name
Grupo Medico Camino Sc
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
03310
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
5541689873
First Name & Middle Initial & Last Name & Degree
Jorge Rojas Serrano
Facility Name
CAIMED México
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06760
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
5565834651
First Name & Middle Initial & Last Name & Degree
Laura Castro Castrezana
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
525579597066
First Name & Middle Initial & Last Name & Degree
Ricardo Correa-Rotter
Facility Name
Instituto Nacional de Enfermedades Respiratorias
City
Mexico City
State/Province
Distrito F
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
525513293141
First Name & Middle Initial & Last Name & Degree
Jesús Arturo Rivero Martínez
Facility Name
AGNI Research and Assessment S.C.
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62330
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
7772156078
First Name & Middle Initial & Last Name & Degree
Abel Causor Torres
Facility Name
Centro de Investigación y Gastroenterología
City
Cuauhtémoc
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
5510546591
First Name & Middle Initial & Last Name & Degree
Alma LAURA Ladron de Guevara Cetina
Facility Name
Instituto Nacional de Cardiologia Ignacio Chavez
City
Mexico
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
525535661465
First Name & Middle Initial & Last Name & Degree
Jose Salvador Lopez Gil
Facility Name
Amsterdam UMC, locatie VUmc
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
Phone
0204440534
First Name & Middle Initial & Last Name & Degree
Daniel van Raalte
Facility Name
Ziekenhuisgroep Twente, locatie Almelo
City
Almelo
State/Province
Overijssel
ZIP/Postal Code
7609 PP
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
Phone
0887084351
First Name & Middle Initial & Last Name & Degree
Goos Laverman
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
http://vivli.org/
Links:
URL
https://trials.lilly.com/en-US/trial/360461
Description
A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes (TREASURE-CKD)
Learn more about this trial
A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
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