A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
- Conditions
- T2DObesityChronic Kidney DiseaseType 2 DiabetesOverweight
- Interventions
- Drug: Placebo
- Registration Number
- NCT05536804
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered SC Tirzepatide Tirzepatide Tirzepatide administered subcutaneously (SC)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Change from Baseline in Kidney Oxygenation in Participants with T2D (BOLD MRI) Baseline, Week 52 Percent Change from Baseline in Renal Sinus Fat Content (MRI) 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 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 Change from Baseline in Glomerular Filtration Rate (GFR) Iohexol Clearance in Milliliter/Minute/Square Meter (ml/min/m²) Baseline, Week 52 Percent Change from Baseline in Renal Fat Content (MRI Proton Density Fat Fraction) Baseline, Week 52
Trial Locations
- Locations (27)
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Kidney Associates of Colorado
🇺🇸Denver, Colorado, United States
American Health Network of Indiana, LLC - Avon
🇺🇸Avon, Indiana, United States
American Health Network of Indiana, LLC - Greenfield
🇺🇸Greenfield, Indiana, United States
Indiana University Health University Hospital
🇺🇸Indianapolis, Indiana, United States
American Health Network of Indiana, LLC - Muncie
🇺🇸Muncie, Indiana, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
🇺🇸Troy, Michigan, United States
University of Washington Medical Center - Montlake
🇺🇸Seattle, Washington, United States
Providence Medical Research Center - Spokane
🇺🇸Spokane, Washington, United States
Zentrum für klinische Studien Dr Hanusch Gmbh
🇦🇹Vienna, Wien, Austria
Klinik Landstraße
🇦🇹Wien, Austria
Klinik Hietzing
🇦🇹Wien, Austria
LMC Clinical Research Inc. (Barrie)
🇨🇦Barrie, Ontario, Canada
LMC Clinical Research Inc. (Thornhill)
🇨🇦Concord, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Fadia El Boreky Medicine
🇨🇦Waterloo, Ontario, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire -T
🇨🇦Sherbrooke, Quebec, Canada
Aarhus Universitetshospital, Skejby
🇩🇰Aarhus, Midtjylland, Denmark
Health Pharma Professional Research S.A. de C.V:
🇲🇽Ciudad de México, Distrito Federal, Mexico
Grupo Medico Camino Sc
🇲🇽Mexico City, Distrito Federal, Mexico
Caimed Investigacion En Salud S.A. de C.V.
🇲🇽Mexico City, Distrito Federal, Mexico
Investigación Nefrológica
🇲🇽Cuernavaca, Morelos, Mexico
Centro de Investigación y Gastroenterología
🇲🇽Cuauhtémoc, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
🇲🇽Mexico, Mexico
Amsterdam UMC, locatie VUmc
🇳🇱Amsterdam, Noord-Holland, Netherlands
Ziekenhuisgroep Twente, locatie Almelo
🇳🇱Almelo, Overijssel, Netherlands