Type 2 Diabetes Clinical Trial
Official title:
A Phase 2b, Double-Blind Study to Investigate the Effect of LY3437943 on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
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 lasts around 31 weeks.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | November 25, 2025 |
| Est. primary completion date | November 25, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | LMC Diabetes & Endocrinology | Brampton | Ontario |
| Canada | Circulate Cardiac & Vascular Centre | Burlington | Ontario |
| Canada | Viacar Recherche Clinique | Greenfield Park | Quebec |
| Canada | 9109-0126 Quebec Inc. | Montreal | Quebec |
| Canada | North York Diagnostic and Cardiac Centre | North York | Ontario |
| Canada | Diex Recherche Joliette | Saint-Charles-Borromée | Quebec |
| Canada | Stouffville Medical Centre | Stouffville | Ontario |
| Canada | Dr. Anil K. Gupta Medicine Professional Corporation | Toronto | Ontario |
| Canada | Fadia El Boreky Medicine | Waterloo | Ontario |
| Italy | Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII | Bergamo | |
| Italy | Centro Cardiologico Monzino | Milan | Milano |
| Italy | Ospedale San Raffaele | Milano | |
| Italy | Azienda Ospedaliera Universitaria Pisana | Pisa | Toscana |
| Spain | Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE) | Sevilla | |
| Spain | Hospital Clinico de Valencia | Valencia | Valenciana |
| Spain | Hospital Universitario Doctor Peset | Valencia | Valenciana, Comunitat |
| United Kingdom | Addenbrooke's Hospital | Cambridge | Cambridgeshire |
| United Kingdom | North Middlesex Hospital | London | London, City Of |
| United Kingdom | Royal London Hospital | London | England |
| United Kingdom | City Hospital, Nottingham University Hospitals | Nottingham | |
| United Kingdom | Vascular Research Team | Salford | Greater Manchester |
| United States | University of Colorado Anschutz Medical Campus | Aurora | Colorado |
| United States | Hope Clinical Research, Inc. | Canoga Park | California |
| United States | Great Lakes Clinical Trials - Ravenswood | Chicago | Illinois |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Endocrine Ips, Pllc | Houston | Texas |
| United States | Victorium Clinical Research - Houston | Houston | Texas |
| United States | Palm Research Center Tenaya | Las Vegas | Nevada |
| United States | The Institute for Liver Health dba Arizona Clinical Trials | Mesa | Arizona |
| United States | NYU Langone Hospital - Long Island | Mineola | New York |
| United States | Catalina Research Institute, LLC | Montclair | California |
| United States | Suncoast Clinical Research, Inc. | New Port Richey | Florida |
| United States | Peninsula Research Associates | Rolling Hills Estates | California |
| United States | Headlands Research - Scottsdale | Scottsdale | Arizona |
| United States | Medical Advancement Centers of Arizona | Tempe | Arizona |
| United States | Tranquility Research | Webster | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Canada, Italy, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline in Glomerular Filtration Rate (GFR) | The GFR in milliliter/minute/square meter (mL/min/m²) using iohexol clearance (mGFR-measured glomerular filtration rate) | Baseline, Week 24 | |
| Secondary | Change from Baseline in Urine Albumin-to-Creatinine Ratio (UACR) | Baseline, Week 24 | ||
| Secondary | Change from Baseline in Creatinine-Corrected Fractional Urinary Sodium Excretion (FENa) | Baseline, Week 24 | ||
| Secondary | Change from Baseline in Filtration Fraction Estimated from Measured Glomerular Filtration Rate (mGFR) | Baseline, Week 24 | ||
| Secondary | Change from Baseline in Renal Mean Arterial Flow as Assessed by Magnetic Resonance Imaging (MRI), Corrected by Hematocrit | Baseline, Week 24 | ||
| Secondary | Change from Baseline in in Mean Arterial Flow (MAF) | Baseline, Week 24 | ||
| Secondary | Change from Baseline in Renal Artery Resistive Index (RARI) | Baseline, Week 24 | ||
| Secondary | Change from Baseline in Renal Blood Flow Velocity Peak Systolic Velocity (PSV) and End-diastolic Velocity (ESV) | Baseline, Week 24 | ||
| Secondary | Change from Baseline in Global Renal Perfusion (MRI) | Baseline, Week 24 | ||
| Secondary | Change from Baseline in Total Renal Parenchyma Volume (MRI) | Baseline, Week 24 | ||
| Secondary | Change from Baseline in Renal Cortex Volume (MRI) | Baseline, Week 24 | ||
| Secondary | Change from Baseline in Renal Cortex T1 (ms) (MRI) | Baseline, Week 24 | ||
| Secondary | Change from Baseline in Medulla T1 (ms) (MRI) | Baseline, Week 24 | ||
| Secondary | Change from Baseline in Renal Cortex R2 (BOLD MRI) | Baseline, Week 24 | ||
| Secondary | Change from Baseline in Medulla R2 | Baseline, Week 24 | ||
| Secondary | Change from Baseline in Body Weight | Baseline, Week 24 | ||
| Secondary | Change from Baseline in 24-hr Urinary Albumin Excretion (UAE) | Baseline, Week 24 | ||
| Secondary | Change from Baseline in Change in 24-hour (hr) Urinary Electrolytes (milligrams/24hr (mg/24h)) | Baseline, Week 24 |
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