ObesityPhase 3TRIUMPH-9NCT07357415
A Study of Retatrutide (LY3437943) in Participants Without Type 2 Diabetes Who Have Obesity or Overweight
A Phase 3 study testing Retatrutide in people with Obesity and Overweight, run by Eli Lilly and Company at 35 sites in 3 countries.
Trial summary
The purpose of this study is to investigate the efficacy and safety of different retatrutide dose escalation schemes in participants without type 2 diabetes who have obesity or overweight. Participation in the study will last about 113 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Retatrutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 35 sitesin 3 countries
- Study dates
- 24 Jan 2026to Nov 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 a Body Mass Index (BMI) at screening
- ≥ 30 kilogram per square meter (kg/m2) OR
- ≥ 27 kg/m2 with presence of at least one of the following weight-related conditions at screening: high blood pressure, abnormal levels of lipid, obstructive sleep apnea, heart disease
- Have at least one unsuccessful attempt to lose weight by dieting
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 type 1 diabetes or type 2 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:
- heart attack
Show all 11Show fewer
- stroke
- hospitalization for unstable angina or 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
35 sites in 3 countries.
35 sites in 3 countries
United States20 sites
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Brigham and Women's Hospital Diabetes Program
Boston, Massachusetts, 02115
CAMC Institute for Academic Medicine
Charleston, West Virginia, 25304
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
Cedar Health Research - Texas Native Health
Dallas, Texas, 75235
Cedar Health Research
Dallas, Texas, 75251
Cedar Health Research - Fort Worth
Fort Worth, Texas, 76132
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96817
Care Access - Huntington Beach
Huntington Beach, California, 92648
New Phase Research and Development
Knoxville, Tennessee, 37909
NYC Research INC
Long Island City, New York, 11106
Los Angeles Institute for Metabolic Research
Los Angeles, California, 90015
Monroe Biomedical Research - Louisville
Louisville, Kentucky, 40213
New Horizon Research Center
Miami, Florida, 33165
Weill Cornell Medical College
New York, New York, 10021
Advanced Research Institute
Ogden, Utah, 84405
Arizona Research Center
Phoenix, Arizona, 85053
Care Access - Raleigh
Raleigh, North Carolina, 27607
Dominion Medical Associates, Inc.
Richmond, Virginia, 23219
Encore Medical Research - Weston
Weston, Florida, 33331
Canada10 sites
Aggarwal and Associates Limited
Brampton, L6T 0G1
Med Trust Research
Courtice, L1E 2J5
Winterberry Research Inc.
Hamilton, L8J 0B6
Diex Recherche Inc. Division Joliette
Joliette, J6E 6A9
Milestone Research Inc.
London, N5W 6A2
Diex Recherche Inc. Division Quebec
Québec, G1V 4T3
Diex Recherche Inc. Division Sherbrooke
Sherbrooke, J1L 0H8
Canadian Phase Onward
Toronto, M3J 0K2
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, M9V 4B4
C.I.C. Mauricie inc.
Trois-Rivières, G8T 7A1
Argentina5 sites
Cicemo Srl
Buenos Aires, 1424
CARDIAMET Investigaciones Médicas
Buenos Aires, C1014ACP
Stat Research S.A.
Buenos Aires, C1023AAB
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI
Centro Médico Viamonte
Buenos Aires, C1120AAC
About this study
Official title: A Phase 3b Study to Investigate the Efficacy and Safety of Different Retatrutide Dose Escalation Schemes in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Controlled, Double-Blind Trial
The purpose of this study is to investigate the efficacy and safety of different retatrutide dose escalation schemes in participants without type 2 diabetes who have obesity or overweight. Participation in the study will last about 113 weeks.
- Conditions
- Obesity, Overweight
- Being tested
- Retatrutide
- 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
| Study group | Role | What they receive |
|---|---|---|
| Retatrutide Dose Escalation 1 | Experimental | Participants will receive retatrutide subcutaneously (SC) Receives: Drug: Retatrutide |
| Retatrutide Dose Escalation 2 | Experimental | Participants will receive retatrutide SC Receives: Drug: Retatrutide |
| Retatrutide Dose Escalation 3 | Experimental | Participants will receive retatrutide SC Receives: Drug: Retatrutide |
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: Baseline, Week 104
Secondary outcomes (7)
Change from Baseline in Waist Circumference
Measured: Baseline, Week 104
Percent Change from Baseline in Triglycerides
Measured: Baseline, Week 104
Change from Baseline in Systolic Blood Pressure
Measured: Baseline, Week 104
Percent Change from Baseline in High Sensitivity C-Reactive Protein
Measured: Baseline, Week 104
Change from Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials (IWQOL-Lite-CT) Total Score
Measured: Baseline, Week 104
Overall Treatment Satisfaction with Medication for Obesity (TS-MO) Scores
Measured: Week 104
Pharmacokinetics (PK): Steady state Average Trough PK Concentration
Measured: Baseline through Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start24 Jan 2026
- Primary completionOct 2028 (estimated)
- Study completionNov 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
- 600 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
- NCT07357415
- Sponsor's protocol ID
- 27795
- Other IDs
- J1I-MC-GZQL
- Acronym
- TRIUMPH-9
- Status last verified
- Jun 2026
- First submitted
- 16 Jan 2026
- Last updated
- 9 Jun 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b Study to Investigate the Efficacy and Safety of Different Retatrutide Dose Escalation Schemes in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Controlled, Double-Blind Trial
- ClinicalTrials.gov ID
- NCT07357415
- Acronym / sponsor ID
- TRIUMPH-9 / 27795
- Conditions
- Obesity, Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 22 Jan 2026 (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.
The purpose of this study is to investigate the efficacy and safety of different retatrutide dose escalation schemes in participants without type 2 diabetes who have obesity or overweight. Participation in the study will last about 113 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 Escalation 1 | Experimental | Drug: RetatrutideParticipants will receive retatrutide subcutaneously (SC) |
| Retatrutide Dose Escalation 2 | Experimental | Drug: RetatrutideParticipants will receive retatrutide SC |
| Retatrutide Dose Escalation 3 | Experimental | Drug: RetatrutideParticipants will receive retatrutide SC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a Body Mass Index (BMI) at screening
- Have at least one unsuccessful attempt to lose weight by dieting
Key exclusion criteria (11 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 type 1 diabetes or type 2 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:
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 Escalation 1, Retatrutide Dose Escalation 2, Retatrutide Dose Escalation 3 |
Primary outcome
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 104
7 secondary outcomes
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 104
Percent Change from Baseline in Triglycerides
Time frame: Baseline, Week 104
Change from Baseline in Systolic Blood Pressure
Time frame: Baseline, Week 104
Percent Change from Baseline in High Sensitivity C-Reactive Protein
Time frame: Baseline, Week 104
Change from Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials (IWQOL-Lite-CT) Total Score
Time frame: Baseline, Week 104
Overall Treatment Satisfaction with Medication for Obesity (TS-MO) Scores
Time frame: Week 104
Pharmacokinetics (PK): Steady state Average Trough PK Concentration
Time frame: Baseline through Week 104
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 9 Jun 2026.
- A Study of Retatrutide (LY3437943) in Participants Without Type 2 Diabetes Who Have Obesity or Overweight (TRIUMPH-9)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
35 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 and Overweight, run by Eli Lilly and Company at 35 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 4 inclusion and 11 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 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Canada, Argentina. 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. 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: Baseline, Week 104). 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 9 Jun 2026.