Clinical trial NCT05536804: A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Overweight
Obesity
Chronic Kidney Disease
Type 2 Diabetes
T2D
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-09-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from Baseline in Kidney Oxygenation in Participants With or Without T2D
timeFrame: Baseline, Week 52
Secondary outcomes:
measure: Change from Baseline in Kidney Oxygenation in Participants with T2D (BOLD MRI)
timeFrame: Baseline, Week 52
measure: Change from Baseline in Kidney Oxygenation in Participants without T2D (BOLD MRI)
timeFrame: Baseline, Week 52
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 52
measure: Percent Change from Baseline in Renal Sinus Fat Content (MRI)
timeFrame: Baseline, Week 52
measure: Percent Change from Baseline in Renal Fat Content (MRI Proton Density Fat Fraction)
timeFrame: Baseline, Week 52
measure: Percent Change from Baseline in Renal Blood Flow (Phase-Contrast MRI)
timeFrame: Baseline, Week 52
measure: Change from Baseline in Apparent Diffusion Coefficient (ADC) MRI
timeFrame: Baseline, Week 52
measure: Change from Baseline in Glomerular Filtration Rate (GFR) Iohexol Clearance in Milliliter/Minute/Square Meter (ml/min/m²)
timeFrame: Baseline, Week 52
measure: Change from Baseline in 24-hour Urinary Albumin Excretion (UAE) in Milligram/24 Hours (mg/24h)
timeFrame: Baseline, Week 52
measure: Percent Change from Baseline in Urine Albumin-to-Creatine Ratio (UACR)
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Denver
country: United States
facility: Kidney Associates of Colorado
state: Colorado
city: Avon
country: United States
facility: American Health Network of Indiana, LLC - Avon
state: Indiana
city: Greenfield
country: United States
facility: American Health Network of Indiana, LLC - Greenfield
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: Muncie
country: United States
facility: American Health Network of Indiana, LLC - Muncie
state: Indiana
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Seattle
country: United States
facility: University of Washington Medical Center - Montlake
state: Washington
city: Spokane
country: United States
facility: Providence Medical Research Center - Spokane
state: Washington
city: Vienna
country: Austria
facility: Zentrum für klinische Studien Dr Hanusch Gmbh
state: Wien
city: Wien
country: Austria
facility: Klinik Landstraße
city: Wien
country: Austria
facility: Klinik Hietzing
city: Barrie
country: Canada
facility: LMC Clinical Research Inc. (Barrie)
state: Ontario
city: Concord
country: Canada
facility: LMC Clinical Research Inc. (Thornhill)
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Waterloo
country: Canada
facility: Fadia El Boreky Medicine
state: Ontario
city: Sherbrooke
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire -T
state: Quebec
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby
state: Midtjylland
city: Ciudad de México
country: Mexico
facility: Health Pharma Professional Research S.A. de C.V:
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Grupo Medico Camino Sc
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Caimed Investigacion En Salud S.A. de C.V.
state: Distrito Federal
city: Cuernavaca
country: Mexico
facility: Investigación Nefrológica
state: Morelos
city: Cuauhtémoc
country: Mexico
facility: Centro de Investigación y Gastroenterología
city: Mexico
country: Mexico
facility: Instituto Nacional de Cardiologia Ignacio Chavez
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie VUmc
state: Noord-Holland
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente, locatie Almelo
state: Overijssel
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: