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OpenTrials
Completed

NCT Number: NCT05936151

A Study of Retatrutide (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 last around 31 weeks.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centricity Research Brampton Endocrinology, Brampton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retatrutide

Drug

Administered SC

Other names: LY3437943

Placebo

Drug

Administered SC

Primary outcomes

  1. Change from Baseline in Glomerular Filtration Rate (mGFR)

    Time frame: 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 outcomes

  1. Change from Baseline in Urine Albumin-to-Creatinine Ratio (UACR)

    Time frame: Baseline, Week 24

  2. Change from Baseline in Creatinine-Corrected Fractional Urinary Sodium Excretion (FENa)

    Time frame: Baseline, Week 24

  3. Change from Baseline in Filtration Fraction Estimated from Measured Glomerular Filtration Rate (mGFR)

    Time frame: Baseline, Week 24

  4. Change from Baseline in Renal Mean Arterial Flow as Assessed by Magnetic Resonance Imaging (MRI), Corrected by Hematocrit

    Time frame: Baseline, Week 24

  5. Change from Baseline in in Mean Arterial Flow (MAF)

    Time frame: Baseline, Week 24

  6. Change from Baseline in Renal Artery Resistive Index (RARI)

    Time frame: Baseline, Week 24

  7. Change from Baseline in Renal Blood Flow Velocity Peak Systolic Velocity (PSV) and End-diastolic Velocity (ESV)

    Time frame: Baseline, Week 24

  8. Change from Baseline in Global Renal Perfusion (MRI)

    Time frame: Baseline, Week 24

  9. Change from Baseline in Total Renal Parenchyma Volume (MRI)

    Time frame: Baseline, Week 24

  10. Change from Baseline in Renal Cortex Volume (MRI)

    Time frame: Baseline, Week 24

  11. Change from Baseline in Renal Cortex T1 (ms) (MRI)

    Time frame: Baseline, Week 24

  12. Change from Baseline in Medulla T1 (ms) (MRI)

    Time frame: Baseline, Week 24

  13. Change from Baseline in Renal Cortex R2 (BOLD MRI)

    Time frame: Baseline, Week 24

  14. Change from Baseline in Medulla R2

    Time frame: Baseline, Week 24

  15. Change from Baseline in Body Weight

    Time frame: Baseline, Week 24

  16. Change from Baseline in 24-hr Urinary Albumin Excretion (UAE)

    Time frame: Baseline, Week 24

  17. Change from Baseline in Change in 24-hour (hr) Urinary Electrolytes (milligrams/24hr (mg/24h))

    Time frame: Baseline, Week 24

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2023
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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