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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)


Outcome Timeframe Baseline, Week 24

NCTID NCT05936151

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2023-07-20

Completion Date 2025-11

Enrollment Target 120

Interventions

DRUG Retatrutide

DRUG Placebo

Locations Recruiting

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa

United States, Arizona, Chandler


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


Catalina Research Institute, LLC

United States, California, Montclair


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