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ObesityPhase 3TRIUMPH-6NCT06859268

A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity

A Phase 3 study testing Retatrutide in people with Obesity, run by Eli Lilly and Company at 53 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a study of retatrutide in participants with obesity. The main purpose is to learn more about how retatrutide maintains body weight loss. The study will have two treatment phases: an 80 week lead-in phase in which all participants will take retatrutide dose 1 and a 36 week randomized, double-blinded phase in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
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
643 participants
Where
53 sitesin 3 countries
Study dates
5 Mar 2025to Apr 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight

Who cannot join

  • Have a self-reported change in body weight >5 kilograms (kg) (11 pounds) within 90 days before screening
  • Have a prior or planned surgical treatment for obesity
  • Have a prior or planned endoscopic procedure and/or device-based therapy for obesity
  • Have Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes
  • Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • Have had within the past 90 days before screening:
Show all 13Show fewer
  • acute myocardial infarction
  • cerebrovascular accident (stroke)
  • hospitalization for unstable angina, or
  • hospitalization due to congestive heart failure
  • Have New York Heart Association Functional Classification Class IV congestive heart failure
  • Have a history of chronic or acute pancreatitis
  • Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening

Trial locations and contacts

53 sites in 3 countries.

53 sites in 3 countries

United States33 sites
  • Dent Neurosciences Research Center, Inc

    Amherst, New York, 14226

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • ALL Medical Research, LLC

    Cooper City, Florida, 33024

  • Florida International Medical Research

    Coral Gables, Florida, 33134

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut, 06517

  • Pacific Diabetes & Endocrine Center

    Honolulu, Hawaii, 96817

  • Care Access - Houston

    Houston, Texas, 77054

  • Alliance for Multispecialty Research, LLC

    Kansas City, Missouri, 64114

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37909

  • Care Access - Lake Charles (Bayou Pines)

    Lake Charles, Louisiana, 70601

  • Vector Clinical Trials

    Las Vegas, Nevada, 89128

  • Alliance for Multispecialty Research, LLC

    Lexington, Kentucky, 40509

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Kubost Clinical Research - Marietta

    Marietta, Georgia, 30062

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149

  • Tekton Research, LLC.

    Moore, Oklahoma, 73160

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Alliance for Multispecialty Research, LLC

    Oak Brook, Illinois, 60523

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Charter Research - Winter Park

    Orlando, Florida, 32803

  • Care Access - Raleigh

    Raleigh, North Carolina, 27607

  • Care Access - Rapid City

    Rapid City, South Dakota, 57701

  • National Clinical Research, Inc

    Richmond, Virginia, 23294

  • Sleep Therapy Research Center

    San Antonio, Texas, 78229

  • Southern California Clinical Research

    Santa Ana, California, 92701

  • Springfield Clinic Main Campus

    Springfield, Illinois, 62703

  • Central Washington Health Services Association d/b/a Confluence Health

    Wenatchee, Washington, 98801

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

Other trials in United States

United Kingdom12 sites
  • FutureMeds - Birmingham

    Birmingham, B21 9RY

  • Oakenhurst Medical Practice

    Blackburn, BB2 1AX

  • Layton Medical Centre

    Blackpool, FY3 7EN

  • Bradford on Avon Health Centre

    Bradford on Avon, BA15 1DQ

  • FutureMeds - Liverpool

    Bromborough, CH62 6EE

  • Cheadle Community Hospital

    Cheadle, ST10 1NS

  • HMC Health Group - Meadows Centre for Health

    Hounslow, TW4 7NR

  • St Bartholomew's Medical Centre

    Oxford, OX4 1XB

  • Atlantic Medical

    Penzance, TR18 3DX

  • The Adam Practice

    Poole, BH16 5PW

  • Woodstock Bower Surgery

    Rotherham, S61 1AH

  • Rame Group Practice

    Torpoint, PL11 2TB

Other trials in United Kingdom

Canada8 sites
  • Aggarwal and Associates Limited

    Brampton, L6T 0G1

  • Circulate Cardiac & Vascular Centre

    Burlington, L7M 1K9

  • Med Trust Research

    Courtice, L1E 2J5

  • Winterberry Research Inc.

    Hamilton, L8J 0B6

  • Centre de Medecine Metabolique de Lanaudiere (CMML)

    Terrebonne, J6X 4P7

  • Care Access - Thunder Bay - Barton Street

    Thunder Bay, P7B 7C7

  • Maple Leaf Research

    Toronto, M5G 1K2

  • C.I.C. Mauricie inc.

    Trois-Rivières, G8T 7A1

Other trials in Canada

About this study

Official title: A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Retatrutide Treatment in the Maintenance of Weight Reduction in Individuals With Obesity

This is a study of retatrutide in participants with obesity. The main purpose is to learn more about how retatrutide maintains body weight loss. The study will have two treatment phases: an 80 week lead-in phase in which all participants will take retatrutide dose 1 and a 36 week randomized, double-blinded phase in which participants will either take retatrutide dose 1, retatrutide dose 2, or switch to placebo. Participation in the study will last around 125 weeks.

Conditions
Obesity
Being tested
Retatrutide, Placebo
Medical subject headings
Obesity

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 NCT06859268
Study groupRoleWhat they receive
Retatrutide Dose 1ExperimentalParticipants will receive retatrutide dose 1 administered subcutaneously (SC) for 116 weeks
Receives: Drug: Retatrutide
Retatrutide Dose 1 to Retatrutide Dose 2ExperimentalParticipants will receive retatrutide dose 1 administered SC for 80 weeks, then retatrutide dose 2 administered SC for an additional 36 weeks
Receives: Drug: Retatrutide
Retatrutide Dose 1 to PlaceboPlacebo comparatorParticipants will receive retatrutide dose 1 administered SC for 80 weeks, then placebo administered SC for an additional 36 weeks
Receives: Drug: Retatrutide; Drug: Placebo

What is being measured

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

  1. Percent Change from Baseline in Body Weight

    Measured: Week 0, Week 116

Secondary outcomes (3)
  1. Change from Baseline in Waist Circumference

    Measured: Week 0, Week 116

  2. Percentage of Body Weight Reduction Achieved at Week 80 that is Maintained at Week 116

    Measured: Week 0, Week 80, Week 116

  3. Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)

    Measured: Week 0, Week 116

Timeline

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

  1. First posted5 Mar 2025
  2. Study start5 Mar 2025
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2028 (estimated)

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
Model description
Phase 3b
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
643 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06859268
Sponsor's protocol ID
27268
Other IDs
J1I-MC-GZQB
Acronym
TRIUMPH-6
Status last verified
Feb 2026
First submitted
28 Feb 2025
Last updated
3 Mar 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, run by Eli Lilly and Company at 53 sites in 3 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 1 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, United Kingdom, Canada. 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?

This study is still under way. Results are not available in the source record yet.

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?

Percent Change from Baseline in Body Weight (time frame: Week 0, Week 116). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 Mar 2026.

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