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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05536804

Collaborator

(none)

140

Enrollment

Locations

Arms

36.8

Anticipated Duration (Months)

5.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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 1 year.

Condition or Disease	Intervention/Treatment	Phase
Overweight Obesity Chronic Kidney Disease Type 2 Diabetes T2D	Drug: Tirzepatide Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 14, 2022

Anticipated Primary Completion Date :

Oct 10, 2025

Anticipated Study Completion Date :

Nov 7, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Tirzepatide

Tirzepatide administered subcutaneously (SC)

Drug: Tirzepatide

Administered SC

Placebo Comparator: Placebo

Placebo administered SC

Drug: Placebo

Administered SC

Outcome Measures

Primary Outcome Measures

Change from Baseline in Kidney Oxygenation in Participants With or Without T2D [Baseline, Week 52]
Blood oxygenation-level dependent magnetic resonance imaging (BOLD MRI)

Secondary Outcome Measures

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]
Percent Change from Baseline in Renal Blood Flow (Phase-Contrast MRI) [Baseline, Week 52]
Change from Baseline in Apparent Diffusion Coefficient (ADC) MRI [Baseline, Week 52]
Change from Baseline in Glomerular Filtration Rate (GFR) Iohexol Clearance in Milliliter/Minute/Square Meter (ml/min/m²) [Baseline, Week 52]
Change from Baseline in 24-hour Urinary Albumin Excretion (UAE) in Milligram/24 Hours (mg/24h) [Baseline, Week 52]
Percent Change from Baseline in Urine Albumin-to-Creatine Ratio (UACR) [Baseline, Week 52]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valley Clinical Trials, Inc.	Northridge	California	United States	91325
2	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045
3	American Health Network of Indiana, LLC - Avon	Avon	Indiana	United States	46123
4	American Health Network of Indiana, LLC - Greenfield	Greenfield	Indiana	United States	46140
5	Indiana University Health University Hospital	Indianapolis	Indiana	United States	46202
6	American Health Network of Indiana, LLC - Muncie	Muncie	Indiana	United States	47304
7	Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan	United States	48098
8	University of Washington Medical Center	Seattle	Washington	United States	98195
9	Providence Medical Research Center - Spokane	Spokane	Washington	United States	99204
10	Zentrum für klinische Studien Dr Hanusch Gmbh	Vienna	Wien	Austria	1060
11	Klinik Landstraße	Wien		Austria	1030
12	Krankenhaus Hietzing	Wien		Austria	1130
13	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4
14	Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de lEstrie-CHUS)	Sherbrooke	Quebec	Canada	J1H 5N4
15	Steno Diabetes Center	Gentofte	Hovedstaden	Denmark	2820
16	Aarhus Universitetshospital, Skejby	Aarhus	Midtjylland	Denmark	8200
17	Health Pharma Professional Research S.A. de C.V:	Ciudad de México	Distrito Federal	Mexico	03100
18	Grupo Medico Camino Sc	Mexico City	Distrito Federal	Mexico	03310
19	CAIMED México	Mexico City	Distrito Federal	Mexico	06760
20	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico City	Distrito F	Mexico	14080
21	Instituto Nacional de Enfermedades Respiratorias	Mexico City	Distrito F	Mexico	14080
22	AGNI Research and Assessment S.C.	Cuernavaca	Morelos	Mexico	62330
23	Centro de Investigación y Gastroenterología	Cuauhtémoc		Mexico	06700
24	Instituto Nacional de Cardiologia Ignacio Chavez	Mexico		Mexico	14080
25	Amsterdam UMC, locatie VUmc	Amsterdam	Noord-Holland	Netherlands	1081 HV
26	Ziekenhuisgroep Twente, locatie Almelo	Almelo	Overijssel	Netherlands	7609 PP

Sponsors and Collaborators

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