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

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05536804
• Other study ID #: 17217
• Secondary ID: I8F-MC-GPIG2021-
• Status: Recruiting
• Phase: Phase 2
• Start date: February 8, 2023
• Est. completion date: February 26, 2026

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: February 26, 2026
• Est. primary completion date: January 29, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Obesity
• Overweight
• Renal Insufficiency, Chronic
• T2D
• Type 2 Diabetes

Intervention

Drug:
• Tirzepatide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Austria	Zentrum für klinische Studien Dr Hanusch Gmbh	Vienna	Wien
Austria	Klinik Hietzing	Wien
Austria	Klinik Landstraße	Wien
Canada	LMC Clinical Research Inc. (Barrie)	Barrie	Ontario
Canada	LMC Clinical Research Inc. (Thornhill)	Concord	Ontario
Canada	Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitair -T	Sherbrooke	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Denmark	Aarhus Universitetshospital, Skejby	Aarhus	Midtjyllan
Denmark	Steno Diabetes Center - Copenhagen	Herlev	Hovedstaden
Mexico	Health Pharma Professional Research S.A. de C.V:	Ciudad de México	Distrito Federal
Mexico	Centro de Investigación y Gastroenterología	Cuauhtémoc
Mexico	AGNI Research and Assessment S.C.	Cuernavaca	Morelos
Mexico	Investigación Nefrológica	Cuernavaca	Morelos
Mexico	Instituto Nacional de Cardiologia Ignacio Chavez	Mexico
Mexico	CAIMED México	Mexico City	Distrito Federal
Mexico	Grupo Medico Camino Sc	Mexico City	Distrito Federal
Netherlands	Ziekenhuisgroep Twente, locatie Almelo	Almelo	Overijssel
Netherlands	Amsterdam UMC, locatie VUmc	Amsterdam	Noord-Holland
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	American Health Network of IN, LLC	Avon	Indiana
United States	Kidney Associates of Colorado	Denver	Colorado
United States	American Health Network of IN, LLC	Greenfield	Indiana
United States	Indiana University Health University Hospital	Indianapolis	Indiana
United States	American Health Network of IN, LLC	Muncie	Indiana
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Providence Medical Research Center - Spokane	Spokane	Washington
United States	Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Denmark,  Mexico,  Netherlands, 

Outcome

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

External Links

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