Clinical trial NCT05936151: A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
Official title: A Phase 2b, Double-Blind Study to Investigate the Effect of Retatrutide on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Overweight or Obesity
CKD
Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-07-07
Enrollment: 146
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: The main purpose of this study is to investigate the effect of retatrutide on renal function in participants with overweight or obesity and chronic kidney disease (CKD), with or without Type 2 Diabetes (T2D). The study will last around 31 weeks.


Eligibility criteria: Inclusion Criteria:

* Have a body mass index (BMI) ≥27 kilogram/square meter (kg/m²)
* Have either

  * no T2D with an HbA1c \< 6.5% or
  * have T2D with an HbA1c ≤ 9.5% and treated with diet and exercise only or with stable doses of up to 3 oral antihyperglycemic medications, with or without basal insulin for at least 90 days before screening.
* Have been diagnosed with chronic kidney disease (CKD).

Exclusion Criteria:

* Have a self-reported change in body weight \>5 kilogram (kg) (11 pounds) within 90 days before screening.
* Have used in 90 days before the screening any of the following antihyperglycemic class: Dipeptidyl Peptidase IV (DPP4) inhibitors, amylin analogs, glucagon-like peptide-RA (GLP-RA), gastric inhibitory polypeptide (GIP)/GIP-1 RA, and short acting or rapid acting insulins or U500 Insulin
* Have a prior or planned surgical treatment for obesity
* Have Type 1 Diabetes (T1D)
* Have acute or chronic hepatitis
* Have a history of malignant disease within 5 years before screening.

Primary outcomes:
measure: Change from Baseline in Glomerular Filtration Rate (mGFR)
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change from Baseline in Urine Albumin-to-Creatinine Ratio (UACR)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Creatinine-Corrected Fractional Urinary Sodium Excretion (FENa)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Filtration Fraction Estimated from Measured Glomerular Filtration Rate (mGFR)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Renal Mean Arterial Flow as Assessed by Magnetic Resonance Imaging (MRI), Corrected by Hematocrit
timeFrame: Baseline, Week 24
measure: Change from Baseline in in Mean Arterial Flow (MAF)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Renal Artery Resistive Index (RARI)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Renal Blood Flow Velocity Peak Systolic Velocity (PSV) and End-diastolic Velocity (ESV)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Global Renal Perfusion (MRI)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Total Renal Parenchyma Volume (MRI)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Renal Cortex Volume (MRI)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Renal Cortex T1 (ms) (MRI)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Medulla T1 (ms) (MRI)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Renal Cortex R2 (BOLD MRI)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Medulla R2
timeFrame: Baseline, Week 24
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 24
measure: Change from Baseline in 24-hr Urinary Albumin Excretion (UAE)
timeFrame: Baseline, Week 24
measure: Change from Baseline in Change in 24-hour (hr) Urinary Electrolytes (milligrams/24hr (mg/24h))
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Chandler
country: United States
facility: The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
state: Arizona
city: Mesa
country: United States
facility: Care Access - 801 South Power Road, Mesa
state: Arizona
city: Scottsdale
country: United States
facility: Headlands Research - Scottsdale
state: Arizona
city: Tempe
country: United States
facility: Medical Advancement Centers of Arizona
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc.
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Brandon
country: United States
facility: Teradan Clinical Trials, LLC
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Ravenswood
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: Fayette
country: United States
facility: Prime Health and Wellness/SKYCRNG
state: Mississippi
city: Las Vegas
country: United States
facility: Palm Research Center Tenaya
state: Nevada
city: Mineola
country: United States
facility: NYU Langone Hospital - Long Island
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: Victorium Clinical Research - Houston
state: Texas
city: Houston
country: United States
facility: Endocrine Ips, Pllc
state: Texas
city: Webster
country: United States
facility: Tranquility Research
state: Texas
city: Brampton
country: Canada
facility: Centricity Research Brampton Endocrinology
state: Ontario
city: Burlington
country: Canada
facility: Circulate Cardiac & Vascular Centre
state: Ontario
city: North York
country: Canada
facility: North York Diagnostic and Cardiac Centre
state: Ontario
city: Stouffville
country: Canada
facility: Stouffville Medical Research Institute Inc.
state: Ontario
city: Toronto
country: Canada
facility: Dr. Anil K. Gupta Medicine Professional Corporation
state: Ontario
city: Waterloo
country: Canada
facility: Fadia El Boreky Medicine
state: Ontario
city: Greenfield Park
country: Canada
facility: Viacar Recherche Clinique
state: Quebec
city: Joliette
country: Canada
facility: Diex Recherche Joliette
state: Quebec
city: Montreal
country: Canada
facility: 9109-0126 Quebec Inc.
state: Quebec
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
state: Milano
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
state: Toscana
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia
state: Valenciana, Comunitat
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
state: Valenciana, Comunitat
city: Sevilla
country: Spain
facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambridgeshire
city: Stockton-on-Tees
country: United Kingdom
facility: FutureMeds Teesside - Middlefield Centre
state: Durham County
city: London
country: United Kingdom
facility: Royal London Hospital
state: England
city: Newcastle
country: United Kingdom
facility: Futuremeds-Newcastle
state: England
city: Salford
country: United Kingdom
facility: Vascular Research Team
state: Greater Manchester
city: London
country: United Kingdom
facility: North Middlesex Hospital
state: London, City Of
city: Nottingham
country: United Kingdom
facility: City Hospital, Nottingham University Hospitals NHS Trust
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: