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.
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
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
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
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 group | Role | What they receive |
|---|---|---|
| Retatrutide Dose 1 | Experimental | Participants will receive retatrutide dose 1 administered subcutaneously (SC) for 116 weeks Receives: Drug: Retatrutide |
| Retatrutide Dose 1 to Retatrutide Dose 2 | Experimental | Participants 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 Placebo | Placebo comparator | Participants 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.
Percent Change from Baseline in Body Weight
Measured: Week 0, Week 116
Secondary outcomes (3)
Change from Baseline in Waist Circumference
Measured: Week 0, Week 116
Percentage of Body Weight Reduction Achieved at Week 80 that is Maintained at Week 116
Measured: Week 0, Week 80, Week 116
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.
- First posted5 Mar 2025
- Study start5 Mar 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06859268
- Acronym / sponsor ID
- TRIUMPH-6 / 27268
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 643 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Phase 3b
| Arm | Type | Receives |
|---|---|---|
| Retatrutide Dose 1 | Experimental | Drug: RetatrutideParticipants will receive retatrutide dose 1 administered subcutaneously (SC) for 116 weeks |
| Retatrutide Dose 1 to Retatrutide Dose 2 | Experimental | Drug: RetatrutideParticipants will receive retatrutide dose 1 administered SC for 80 weeks, then retatrutide dose 2 administered SC for an additional 36 weeks |
| Retatrutide Dose 1 to Placebo | Placebo comparator | Drug: Retatrutide, Drug: PlaceboParticipants will receive retatrutide dose 1 administered SC for 80 weeks, then placebo administered SC for an additional 36 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RetatrutideAlso: LY3437943Administered SC | Drug | Retatrutide Dose 1, Retatrutide Dose 1 to Placebo, Retatrutide Dose 1 to Retatrutide Dose 2 |
| PlaceboAdministered SC | Drug | Retatrutide Dose 1 to Placebo |
Primary outcome
Percent Change from Baseline in Body Weight
Time frame: Week 0, Week 116
3 secondary outcomes
Change from Baseline in Waist Circumference
Time frame: Week 0, Week 116
Percentage of Body Weight Reduction Achieved at Week 80 that is Maintained at Week 116
Time frame: Week 0, Week 80, Week 116
Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)
Time frame: Week 0, Week 116
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals with Obesity (TRIUMPH-6)Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
53 sites in 3 countries: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.