A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
- Conditions
- Overweight or ObesityType 2 DiabetesCKD
- Interventions
- Drug: Placebo
- Registration Number
- NCT05936151
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 146
-
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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive LY3437943 Retatrutide Retatrutide Participants will receive multiple doses of retatrutide subcutaneously (SC)
- Primary Outcome Measures
Name Time Method Change from Baseline in Glomerular Filtration Rate (mGFR) Baseline, Week 24 The GFR in milliliter/minute per1.73 square meter (mL/min/1.73 m²) using iohexol clearance (mGFR-measured glomerular filtration rate)
- Secondary Outcome Measures
Name Time Method Change from Baseline in Medulla T1 (ms) (MRI) Baseline, Week 24 Change from Baseline in Urine Albumin-to-Creatinine Ratio (UACR) Baseline, Week 24 Change from Baseline in Creatinine-Corrected Fractional Urinary Sodium Excretion (FENa) Baseline, Week 24 Change from Baseline in Filtration Fraction Estimated from Measured Glomerular Filtration Rate (mGFR) Baseline, Week 24 Change from Baseline in Renal Mean Arterial Flow as Assessed by Magnetic Resonance Imaging (MRI), Corrected by Hematocrit Baseline, Week 24 Change from Baseline in in Mean Arterial Flow (MAF) Baseline, Week 24 Change from Baseline in Renal Artery Resistive Index (RARI) Baseline, Week 24 Change from Baseline in Renal Blood Flow Velocity Peak Systolic Velocity (PSV) and End-diastolic Velocity (ESV) Baseline, Week 24 Change from Baseline in Global Renal Perfusion (MRI) Baseline, Week 24 Change from Baseline in Total Renal Parenchyma Volume (MRI) Baseline, Week 24 Change from Baseline in Renal Cortex Volume (MRI) Baseline, Week 24 Change from Baseline in Renal Cortex T1 (ms) (MRI) Baseline, Week 24 Change from Baseline in Renal Cortex R2 (BOLD MRI) Baseline, Week 24 Change from Baseline in Body Weight Baseline, Week 24 Change from Baseline in Medulla R2 Baseline, Week 24 Change from Baseline in 24-hr Urinary Albumin Excretion (UAE) Baseline, Week 24 Change from Baseline in Change in 24-hour (hr) Urinary Electrolytes (milligrams/24hr (mg/24h)) Baseline, Week 24
Trial Locations
- Locations (42)
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
🇺🇸Chandler, Arizona, United States
Care Access - 801 South Power Road, Mesa
🇺🇸Mesa, Arizona, United States
Headlands Research - Scottsdale
🇺🇸Scottsdale, Arizona, United States
Medical Advancement Centers of Arizona
🇺🇸Tempe, Arizona, United States
Hope Clinical Research, Inc.
🇺🇸Canoga Park, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Teradan Clinical Trials, LLC
🇺🇸Brandon, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
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