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
3 other identifiers
interventional
146
5 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2023
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2023
CompletedFirst Posted
Study publicly available on registry
July 7, 2023
CompletedStudy Start
First participant enrolled
July 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2025
CompletedNovember 25, 2025
November 1, 2025
2.2 years
June 30, 2023
November 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
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 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
- +12 more secondary outcomes
Study Arms (2)
Retatrutide
EXPERIMENTALParticipants will receive multiple doses of retatrutide subcutaneously (SC)
Placebo
PLACEBO COMPARATORParticipants will receive LY3437943
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, 85225, United States
Care Access - 801 South Power Road, Mesa
Mesa, Arizona, 85206, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260, United States
Medical Advancement Centers of Arizona
Tempe, Arizona, 85283, United States
Hope Clinical Research, Inc.
Canoga Park, California, 91303, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Teradan Clinical Trials, LLC
Brandon, Florida, 33511, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640, United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202, United States
Prime Health and Wellness/SKYCRNG
Fayette, Mississippi, 39069, United States
Palm Research Center Tenaya
Las Vegas, Nevada, 89128, United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Victorium Clinical Research - Houston
Houston, Texas, 77024, United States
Endocrine Ips, Pllc
Houston, Texas, 77079, United States
Tranquility Research
Webster, Texas, 77598, United States
Centricity Research Brampton Endocrinology
Brampton, Ontario, L6S 0C6, Canada
Circulate Cardiac & Vascular Centre
Burlington, Ontario, L7M 1K9, Canada
North York Diagnostic and Cardiac Centre
North York, Ontario, M6B 3H7, Canada
Stouffville Medical Research Institute Inc.
Stouffville, Ontario, L4A 1H2, Canada
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, Ontario, M9V 4B4, Canada
Fadia El Boreky Medicine
Waterloo, Ontario, N2J 1C4, Canada
Viacar Recherche Clinique
Greenfield Park, Quebec, J4V 2G8, Canada
Diex Recherche Joliette
Joliette, Quebec, J6E 6A9, Canada
9109-0126 Quebec Inc.
Montreal, Quebec, H4N 2W2, Canada
Centro Cardiologico Monzino
Milan, Milano, 20138, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Tuscany, 56126, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, 46010, Spain
Hospital Universitario Doctor Peset
Valencia, Valenciana, Comunitat, 46017, Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Seville, 41003, Spain
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
FutureMeds Teesside - Middlefield Centre
Stockton-on-Tees, Durham County, TS19 8PE, United Kingdom
Royal London Hospital
London, England, E1 1BB, United Kingdom
Futuremeds-Newcastle
Newcastle, England, United Kingdom
Vascular Research Team
Salford, Greater Manchester, M6 8HD, United Kingdom
North Middlesex Hospital
London, London, City of, N18 1QX, United Kingdom
City Hospital, Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Phase 2b
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2023
First Posted
July 7, 2023
Study Start
July 20, 2023
Primary Completion
October 1, 2025
Study Completion
October 21, 2025
Last Updated
November 25, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.