CKD, Overweight or Obesity, Type 2 Diabetes
Conditions
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.
Interventions
DRUGPlacebo
Administered SC
DRUGRetatrutide
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Phase 2b
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 Urine Albumin-to-Creatinine Ratio (UACR) | Baseline, Week 24 |
| Change from Baseline in Renal Cortex T1 (ms) (MRI) | Baseline, Week 24 |
| Change from Baseline in Medulla T1 (ms) (MRI) | Baseline, Week 24 |
| Change from Baseline in Renal Cortex R2 (BOLD MRI) | Baseline, Week 24 |
| Change from Baseline in Medulla R2 | Baseline, Week 24 |
| Change from Baseline in Body Weight | 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 |
| Change from Baseline in Renal Cortex Volume (MRI) | Baseline, Week 24 |
Countries
Canada, Italy, Spain, United Kingdom, United States
Outcome results
None listed