A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; CKD; Overweight or Obesity
• Intervention / Treatment: Drug: Placebo; Drug: Retatrutide

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6S 0C6
      • Centricity Research Brampton Endocrinology
    • Burlington, Ontario, Canada, L7M 1K9
      • Circulate Cardiac & Vascular Centre
    • North York, Ontario, Canada, M6B 3H7
      • North York Diagnostic and Cardiac Centre
    • Stouffville, Ontario, Canada, L4A 1H2
      • Stouffville Medical Research Institute Inc.
    • Toronto, Ontario, Canada, M9V 4B4
      • Dr. Anil K. Gupta Medicine Professional Corporation
    • Waterloo, Ontario, Canada, N2J 1C4
      • Fadia El Boreky Medicine
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2G8
      • Viacar Recherche Clinique
    • Joliette, Quebec, Canada, J6E 6A9
      • Diex Recherche Joliette
    • Montreal, Quebec, Canada, H4N 2W2
      • 9109-0126 Quebec Inc.
• Italy
  • Bergamo, Italy, 24127
    • Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
  • Milan, Italy, 20132
    • Ospedale San Raffaele
  • Milano
    • Milan, Milano, Italy, 20138
      • Centro Cardiologico Monzino
  • Tuscany
    • Pisa, Tuscany, Italy, 56126
      • Azienda Ospedaliera Universitaria Pisana
• Spain
  • Seville, Spain, 41003
    • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
  • Valenciana, Comunitat
    • Valencia, Valenciana, Comunitat, Spain, 46010
      • Hospital Clinico de Valencia
    • Valencia, Valenciana, Comunitat, Spain, 46017
      • Hospital Universitario Doctor Peset
• United Kingdom
  • Nottingham, United Kingdom, NG5 1PB
    • City Hospital, Nottingham University Hospitals NHS Trust
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
      • Addenbrooke's Hospital
  • Durham County
    • Stockton-on-Tees, Durham County, United Kingdom, TS19 8PE
      • FutureMeds Teesside - Middlefield Centre
  • England
    • London, England, United Kingdom, E1 1BB
      • Royal London Hospital
    • Newcastle, England, United Kingdom
      • Futuremeds-Newcastle
  • Greater Manchester
    • Salford, Greater Manchester, United Kingdom, M6 8HD
      • Vascular Research Team
  • London, City of
    • London, London, City of, United Kingdom, N18 1QX
      • North Middlesex Hospital
• United States
  • Arizona
    • Chandler, Arizona, United States, 85225
      • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
    • Mesa, Arizona, United States, 85206
      • Care Access - 801 South Power Road, Mesa
    • Scottsdale, Arizona, United States, 85260
      • Headlands Research - Scottsdale
    • Tempe, Arizona, United States, 85283
      • Medical Advancement Centers of Arizona
  • California
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research, Inc.
    • Montclair, California, United States, 91763
      • Catalina Research Institute, LLC
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
  • Florida
    • Brandon, Florida, United States, 33511
      • Teradan Clinical Trials, LLC
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials - Ravenswood
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health University Hospital
  • Mississippi
    • Fayette, Mississippi, United States, 39069
      • Prime Health and Wellness/SKYCRNG
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Palm Research Center Tenaya
  • New York
    • Mineola, New York, United States, 11501
      • NYU Langone Hospital - Long Island
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Texas
    • Houston, Texas, United States, 77079
      • Endocrine Ips, Pllc
    • Houston, Texas, United States, 77024
      • Victorium Clinical Research - Houston
    • Webster, Texas, United States, 77598
      • Tranquility Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive LY3437943	Drug: Placebo; Administered SC
Experimental: Retatrutide; Participants will receive multiple doses of retatrutide subcutaneously (SC)	Drug: Retatrutide; Administered SC; Other Names: LY3437943

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Glomerular Filtration Rate (mGFR)	The GFR in milliliter/minute per1.73 square meter (mL/min/1.73 m²) using iohexol clearance (mGFR-measured glomerular filtration rate)	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Urine Albumin-to-Creatinine Ratio (UACR)	Baseline, Week 24
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 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 Renal Cortex Volume (MRI)	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 Renal Mean Arterial Flow as Assessed by Magnetic Resonance Imaging (MRI), Corrected by Hematocrit	Baseline, Week 24
Change from Baseline in Change in 24-hour (hr) Urinary Electrolytes (milligrams/24hr (mg/24h))	Baseline, Week 24

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

Helpful Links

• A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Actual): October 1, 2025
• Study Completion (Actual): October 21, 2025

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus, Type 2; retatrutide
• Other Study ID Numbers: 18725; J1I-MC-GZBU (Other Identifier: Eli Lilly and Company); 2023-504583-42-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes