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Overweight or ObesityPhase 2NCT05936151

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 2 study testing Retatrutide in people with Overweight or Obesity and CKD, run by Eli Lilly and Company at 42 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overweight or Obesity, CKD, Type 2 Diabetes
What is being tested?
Retatrutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
146 participants
Where
42 sitesin 5 countries
Study dates
20 Jul 2023to 21 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

42 sites in 5 countries.

42 sites in 5 countries

United States19 sites

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Teradan Clinical Trials, LLC

    Brandon, Florida, 33511

  • Hope Clinical Research, Inc.

    Canoga Park, California, 91303

  • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa

    Chandler, Arizona, 85225

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois, 60640

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Prime Health and Wellness/SKYCRNG

    Fayette, Mississippi, 39069

  • Victorium Clinical Research - Houston

    Houston, Texas, 77024

  • Endocrine Ips, Pllc

    Houston, Texas, 77079

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202

  • Palm Research Center Tenaya

    Las Vegas, Nevada, 89128

  • Care Access - 801 South Power Road, Mesa

    Mesa, Arizona, 85206

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274

  • Headlands Research - Scottsdale

    Scottsdale, Arizona, 85260

  • Medical Advancement Centers of Arizona

    Tempe, Arizona, 85283

  • Tranquility Research

    Webster, Texas, 77598

Other trials in United States

Canada9 sites

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6

  • Circulate Cardiac & Vascular Centre

    Burlington, Ontario, L7M 1K9

  • Viacar Recherche Clinique

    Greenfield Park, Quebec, J4V 2G8

  • Diex Recherche Joliette

    Joliette, Quebec, J6E 6A9

  • 9109-0126 Quebec Inc.

    Montreal, Quebec, H4N 2W2

  • North York Diagnostic and Cardiac Centre

    North York, Ontario, M6B 3H7

  • Stouffville Medical Research Institute Inc.

    Stouffville, Ontario, L4A 1H2

  • Dr. Anil K. Gupta Medicine Professional Corporation

    Toronto, Ontario, M9V 4B4

  • Fadia El Boreky Medicine

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

United Kingdom7 sites

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire, CB2 2QQ

  • Royal London Hospital

    London, England, E1 1BB

  • North Middlesex Hospital

    London, London, City of, N18 1QX

  • Futuremeds-Newcastle

    Newcastle, England

  • City Hospital, Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • Vascular Research Team

    Salford, Greater Manchester, M6 8HD

  • FutureMeds Teesside - Middlefield Centre

    Stockton-on-Tees, Durham County, TS19 8PE

Other trials in United Kingdom

Italy4 sites

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127

  • Centro Cardiologico Monzino

    Milan, Milano, 20138

  • Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, Tuscany, 56126

Other trials in Italy

Spain3 sites

  • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

    Seville, 41003

  • Hospital Clinico de Valencia

    Valencia, Valenciana, Comunitat, 46010

  • Hospital Universitario Doctor Peset

    Valencia, Valenciana, Comunitat, 46017

Other trials in Spain

About this study

Official 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

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.

Being tested
Retatrutide, Placebo
Medical subject headings
Overweight, Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RetatrutideDrug

    Also called LY3437943

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT05936151
Study groupRoleWhat they receive
RetatrutideExperimentalParticipants will receive multiple doses of retatrutide subcutaneously (SC)
Receives: Drug: Retatrutide
PlaceboPlacebo comparatorParticipants will receive LY3437943
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline, Week 24

Secondary outcomes (17)

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

  14. Change from Baseline in Medulla R2

    Measured: Baseline, Week 24

  15. Change from Baseline in Body Weight

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

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

    Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study start20 Jul 2023
  3. Primary completion1 Oct 2025
  4. Study completion21 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05936151
Sponsor's protocol ID
18725
Other IDs
J1I-MC-GZBU, 2023-504583-42-00, 2023
Status last verified
Nov 2025
First submitted
30 Jun 2023
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Heerspink HJL, van Raalte DH, Bjornstad P, Bunck MC, Wu P, Tunali I, Milicevic Z, Koeneman L. Rationale, design and baseline characteristics of the TRANSCEND-CKD trial of retatrutide in patients with chronic kidney disease. Nephrol Dial Transplant. 2026 May 29;41(6):1058-1068. doi: 10.1093/ndt/gfaf230.

    PubMed 41160422

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Retatrutide in people with Overweight or Obesity and CKD, run by Eli Lilly and Company at 42 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Canada, United Kingdom, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Glomerular Filtration Rate (mGFR) (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05936151, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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