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

November 24, 2025 updated by: Eli Lilly and Company

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: clinical_inquiry_hub@lilly.com

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline, Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in Urine Albumin-to-Creatinine Ratio (UACR)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Creatinine-Corrected Fractional Urinary Sodium Excretion (FENa)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Filtration Fraction Estimated from Measured Glomerular Filtration Rate (mGFR)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in in Mean Arterial Flow (MAF)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Renal Artery Resistive Index (RARI)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Renal Blood Flow Velocity Peak Systolic Velocity (PSV) and End-diastolic Velocity (ESV)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Global Renal Perfusion (MRI)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Total Renal Parenchyma Volume (MRI)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Renal Cortex Volume (MRI)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Renal Cortex T1 (ms) (MRI)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Medulla T1 (ms) (MRI)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Renal Cortex R2 (BOLD MRI)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Medulla R2
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Body Weight
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in 24-hr Urinary Albumin Excretion (UAE)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Renal Mean Arterial Flow as Assessed by Magnetic Resonance Imaging (MRI), Corrected by Hematocrit
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Change in 24-hour (hr) Urinary Electrolytes (milligrams/24hr (mg/24h))
Time Frame: Baseline, Week 24
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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