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

Status: Active_not_recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
California
Valley Clinical Trials, Inc.
Northridge
Colorado
University of Colorado Anschutz Medical Campus
Aurora
Kidney Associates of Colorado
Denver
Indiana
American Health Network of Indiana, LLC - Avon
Avon
American Health Network of Indiana, LLC - Greenfield
Greenfield
Indiana University Health University Hospital
Indianapolis
American Health Network of Indiana, LLC - Muncie
Muncie
Michigan
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy
Washington
University of Washington Medical Center - Montlake
Seattle
Providence Medical Research Center - Spokane
Spokane
Other Locations
Austria
Klinik Hietzing
Vienna
Klinik Landstraße
Vienna
Zentrum für klinische Studien Dr Hanusch Gmbh
Vienna
Canada
LMC Clinical Research Inc. (Barrie)
Barrie
LMC Clinical Research Inc. (Thornhill)
Concord
Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire -T
Sherbrooke
Toronto General Hospital
Toronto
Fadia El Boreky Medicine
Waterloo
Denmark
Aarhus Universitetshospital, Skejby
Aarhus
Mexico
Centro de Investigación y Gastroenterología
Cuauhtémoc
Investigación Nefrológica
Cuernavaca
Instituto Nacional de Cardiologia Ignacio Chavez
México
Caimed Investigacion En Salud S.A. de C.V.
Mexico City
Grupo Medico Camino Sc
Mexico City
Health Pharma Professional Research S.A. de C.V:
Mexico City
Netherlands
Ziekenhuisgroep Twente, locatie Almelo
Almelo
Amsterdam UMC, locatie VUmc
Amsterdam
Time Frame
Start Date: 2023-02-08
Completion Date: 2026-10
Participants
Target number of participants: 140
Treatments
Experimental: Tirzepatide
Tirzepatide administered subcutaneously (SC)
Placebo_comparator: Placebo
Placebo administered SC
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov