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ObesityPhase 3TRIUMPH-4NCT05931367

A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee

A Phase 3 study testing Retatrutide in people with Obesity and Overweight, run by Eli Lilly and Company at 49 sites in 6 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 evaluate the safety and efficacy of retatrutide once-weekly in participants who have obesity or are overweight and have osteoarthritis (OA) of the knee. The study will lasts about 77 weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Overweight, Osteo Arthritis Knee
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
445 participants
Where
49 sitesin 6 countries
Study dates
1 Aug 2023to 14 Nov 2025
Phase
Phase 3
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/kg/m² at screening.
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
  • Have index knee pain for >12 weeks prior to screening, and presence of index knee pain for >15 days over the previous month.
  • Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening.
  • Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.

Who cannot join

  • Have had steroid joint injections within 90 days of screening.
  • Have had other joint injections and procedures within 6 months of screening.
  • Have joint disease other than osteoarthritis.
  • Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days prior to screening.
  • Have been taking weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
  • Have a prior or planned surgical treatment for obesity.
  • Have diabetes mellitus.

Trial locations and contacts

49 sites in 6 countries.

49 sites in 6 countries

United States13 sites

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Northwestern University

    Chicago, Illinois, 60611

  • Mercy Family Clinic

    Dallas, Texas, 75211

  • Suncoast Research Group

    Miami, Florida, 33135

  • Arizona Research Center

    Phoenix, Arizona, 85053

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Clinvest Research LLC

    Springfield, Missouri, 65807

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

Other trials in United States

Canada10 sites

  • Viable Clinical Research

    Bridgewater, Nova Scotia, B4V 3N2

  • C-health Research

    Calgary, Alberta, T2V 4J2

  • Wharton Medical Clinic

    Hamilton, Ontario, L8L 5G8

  • Alpha Recherche Clinique

    Québec, G2J 0C4

  • ALPHA Recherche Clinique

    Québec, G3K 2P8

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario, N7T 4X3

  • Viable Clinical Research

    Scarborough Village, Ontario, M1P 2T7

  • Eastern Health - General Hospital

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Stouffville Medical Research Institute Inc.

    Stouffville, Ontario, L4A 1H2

  • Canadian Phase Onward

    Toronto, Ontario, M3J 0K2

Other trials in Canada

Australia8 sites

  • Paratus Clinical Research Western Sydney

    Blacktown, New South Wales, 2148

  • Emeritus Research

    Botany, New South Wales, 2019

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Core Research Group

    Brisbane, Queensland, 4064

  • Paratus Clinical Research Canberra

    Bruce, Australian Capital Territory, 2617

  • Emeritus Research

    Camberwell, Victoria, 3124

  • Barwon Health

    Geelong, Victoria, 3220

  • CDH Research Institute

    Maroochydore, Queensland, 4558

Other trials in Australia

Spain8 sites

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

  • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval")

    Ferrol, A Coruña, 15405

  • Hospital Quirón Málaga

    Málaga, Andalusia, 29004

  • Hospital Universitario Infanta Sofía

    San Sebastián de los Reyes, Madrid, 28702

  • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

    Seville, 41003

  • Hospital General Universitario de Valencia

    Valencia, Valenciana, 46014

Other trials in Spain

Mexico7 sites

  • Investigacion y Biomedicina de Chihuahua

    Chihuahua City, 31000

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

    Ciudad Madero, Tamaulipas, 89440

  • Consultorio Médico

    Guadalajara, Jalisco, 44210

  • Kohler and Milstein Research S.A. de C.V.

    Mérida, Yucatán, 97070

  • IMED Internal Medicine Clin Trials

    Monterrey, Nuevo León, 64020

  • Clínica García Flores SC

    Monterrey, Nuevo León, 64610

  • Unidad Médica para la Salud Integral

    San Nicolás de los Garza, Nuevo León, 66465

Other trials in Mexico

United Kingdom3 sites

  • Panthera Biopartners - North London

    Enfield, London, EN3 4GS

  • Leicester General Hospital

    Leicester, Leicestershire, LE5 4PW

  • Panthera Biopartners - Sheffield

    Sheffield, S2 5FX

Other trials in United Kingdom

About this study

Official title: A Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial

The main purpose of this study is to evaluate the safety and efficacy of retatrutide once-weekly in participants who have obesity or are overweight and have osteoarthritis (OA) of the knee. The study will lasts about 77 weeks.

Being tested
Retatrutide, Placebo
Medical subject headings
Obesity, Overweight

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 NCT05931367
Study groupRoleWhat they receive
Retatrutide Dose 1ExperimentalParticipants will receive retatrutide subcutaneously (SC).
Receives: Drug: Retatrutide
Retatrutide Dose 2ExperimentalParticipants will receive retatrutide SC.
Receives: Drug: Retatrutide
PlaceboPlacebo comparatorParticipants will receive placebo.
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 the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score

    Measured: Baseline, Week 68

  2. Percent Change from Baseline in Body Weight

    Measured: Baseline, Week 68

Secondary outcomes (11)

  1. Change from Baseline in the WOMAC Physical Function Subscale Score

    Measured: Baseline, Week 68

  2. Change from Baseline in Waist Circumference

    Measured: Baseline, Week 68

  3. Percent Change from Baseline in Total Cholesterol

    Measured: Baseline, Week 68

  4. Percent Change from Baseline in Triglycerides

    Measured: Baseline, Week 68

  5. Change from Baseline in Body Mass Index (BMI)

    Measured: Baseline, Week 68

  6. Change from Baseline in Systolic Blood Pressure (SBP)

    Measured: Baseline, Week 68

  7. Change from Baseline in Diastolic Blood Pressure (DBP)

    Measured: Baseline, Week 68

  8. Percent Change from Baseline in Fasting Insulin

    Measured: Baseline, Week 68

  9. Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score

    Measured: Baseline, Week 68

  10. Change from Baseline in Average Pain Intensity Numeric Rating Score (API-NRS) Score

    Measured: Baseline, Week 68

  11. Change from Baseline in Worst Pain Intensity Numeric Rating Score (WPI-NRS) Score

    Measured: Baseline, Week 68

Timeline

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

  1. First posted5 Jul 2023
  2. Study start1 Aug 2023
  3. Primary completion14 Nov 2025
  4. Study completion14 Nov 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
445 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05931367
Sponsor's protocol ID
18583
Other IDs
J1I-MC-GZBN, 2023-503660-17-00, 2023
Acronym
TRIUMPH-4
Status last verified
Jan 2026
First submitted
27 Jun 2023
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Retatrutide in people with Obesity and Overweight, run by Eli Lilly and Company at 49 sites in 6 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 7 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Canada, Australia, Spain, Mexico and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score (time frame: Baseline, Week 68). The study lists 2 primary outcomes in all. 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 NCT05931367.

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 21 Jan 2026.

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