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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Overweight, Obesity, Chronic Kidney Disease, Type 2 Diabetes, T2D

In brief

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.

Key facts

Study ID

NCT05536804

Run by

Eli Lilly and Company

People needed

140

Starts

2023-02-08

Expected to finish

2026-10-01

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Klinik Landstraße — Vienna, Austria
• Zentrum für klinische Studien Dr Hanusch Gmbh — Vienna, Austria
• Klinik Hietzing — 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
• Health Pharma Professional Research S.A. de C.V: — Mexico City, Mexico
• Grupo Medico Camino Sc — Mexico City, Mexico
• Caimed Investigacion En Salud S.A. de C.V. — Mexico City, Mexico
• Instituto Nacional de Cardiologia Ignacio Chavez — México, Mexico

Full record on ClinicalTrials.gov

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