Clinical trial
A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
Active, not recruiting · Phase 2 · 6 countries · Registry ID NCT05536804
Active, not recruitingPhase 2Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionOverweight, Obesity, Chronic Kidney Disease, Type 2 Diabetes, T2D
Full registry 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) ≥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
Treatments and study arms
Tirzepatide
Drug
Administered SC
Placebo
Drug
Administered SC
Primary outcomes
Percent Change from Baseline in Renal Sinus Fat Content (MRI)Baseline, Week 52
Study locations
27 locations were listed when this page was built. The first 40 are shown.
Klinik Hietzing🇦🇹 Vienna, Austria
Klinik Landstraße🇦🇹 Vienna, Austria
Zentrum für klinische Studien Dr Hanusch Gmbh🇦🇹 Vienna, Austria
LMC Clinical Research Inc. (Barrie)🇨🇦 Barrie, Canada
LMC Clinical Research Inc. (Thornhill)🇨🇦 Concord, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire -T🇨🇦 Sherbrooke, Canada
Toronto General Hospital🇨🇦 Toronto, Canada
Fadia El Boreky Medicine🇨🇦 Waterloo, Canada
Aarhus Universitetshospital, Skejby🇩🇰 Aarhus, Denmark
Centro de Investigación y Gastroenterología🇲🇽 Cuauhtémoc, Mexico
Investigación Nefrológica🇲🇽 Cuernavaca, Mexico
Caimed Investigacion En Salud S.A. de C.V.🇲🇽 Mexico City, Mexico
Grupo Medico Camino Sc🇲🇽 Mexico City, Mexico
Health Pharma Professional Research S.A. de C.V:🇲🇽 Mexico City, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez🇲🇽 México, Mexico
Ziekenhuisgroep Twente, locatie Almelo🇳🇱 Almelo, Netherlands
Amsterdam UMC, locatie VUmc🇳🇱 Amsterdam, Netherlands
University of Colorado Anschutz Medical Campus🇺🇸 Aurora, Colorado, United States
American Health Network of Indiana, LLC - Avon🇺🇸 Avon, Indiana, United States
Kidney Associates of Colorado🇺🇸 Denver, Colorado, 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
Valley Clinical Trials, Inc.🇺🇸 Northridge, California, United States
University of Washington Medical Center - Montlake🇺🇸 Seattle, Washington, United States
Providence Medical Research Center - Spokane🇺🇸 Spokane, Washington, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division🇺🇸 Troy, Michigan, United States