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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
Description
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.
Trial 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.
Study Info
Organization
Eli Lilly and Company
Primary Outcome
Change from Baseline in Glomerular Filtration Rate (mGFR)
Interventions
Locations Recruiting
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
United States, Arizona, Chandler
Care Access - 801 South Power Road, Mesa
United States, Arizona, Mesa
Headlands Research - Scottsdale
United States, Arizona, Scottsdale
Medical Advancement Centers of Arizona
United States, Arizona, Tempe
Hope Clinical Research, Inc.
United States, California, Canoga Park
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