ObesityPhase 3TRIUMPH-8NCT07232719
A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight
A Phase 3 study testing Retatrutide in people with Obesity and Overweight, run by Eli Lilly and Company at 31 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of retatrutide compared with placebo for body weight reduction. Participation in the study will last about 65 weeks and may include about 18 visits. 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?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 17 Nov 2025to Jul 2027
- 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) of:
- ≥30 kilogram per square meter (kg/m2) OR
- ≥27 kg/m2 with at least one of the following weight-related conditions: 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 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
- acute myocardial infarction
Show all 12Show fewer
- 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
31 sites in 2 countries.
31 sites in 2 countries
United States19 sites
Care Access - Arlington Heights
Arlington Heights, Illinois, 60005
JEM Research Institute
Atlantis, Florida, 33462
Pharmasite Research, Inc.
Baltimore, Maryland, 21208
Clinical Research Professionals
Chesterfield, Missouri, 63005
Cedar Health Research
Dallas, Texas, 75251
Headlands Research-El Paso
El Paso, Texas, 79902
Cedar Health Research - Euless
Euless, Texas, 76040
Cedar Health Research - Fort Worth
Fort Worth, Texas, 76132
Care Access - Houston
Houston, Texas, 77054
L-MARC Research Center
Louisville, Kentucky, 40213
IMA Clinical Research Monroe - Armand
Monroe, Louisiana, 71201
IMA Clinical Research Manhattan
New York, New York, 10036
Headlands Research Orlando
Orlando, Florida, 32806
Artemis Institute for Clinical Research
Riverside, California, 92503
IMA Clinical Research San Antonio
San Antonio, Texas, 78229
Clinvest Headlands Llc
Springfield, Missouri, 65807
Care Access - Tamarac
Tamarac, Florida, 33321
IMA Clinical Research Warren
Warren Township, New Jersey, 07059
Trial Management Associates - Wilmington - Floral Parkway
Wilmington, North Carolina, 28403
United Kingdom12 sites
FutureMeds - Birmingham
Birmingham, B21 9RY
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
Albany House Medical Centre
Wellingborough, NN8 4RW
About this study
Official title: A Phase 3b Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial
The purpose of this study is to evaluate the efficacy and safety of retatrutide compared with placebo for body weight reduction.
Participation in the study will last about 65 weeks and may include about 18 visits.
- Conditions
- Obesity, Overweight
- 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 group | Role | What they receive |
|---|---|---|
| Retatrutide Dose 1 | Experimental | Participants will receive retatrutide subcutaneously (SC) Receives: Drug: Retatrutide |
| Retatrutide Dose 2 | Experimental | Participants will receive retatrutide SC Receives: Drug: Retatrutide |
| Placebo | Placebo comparator | Participants will receive placebo SC Receives: 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: Baseline, Week 56
Secondary outcomes (4)
Change from Baseline in Systolic Blood Pressure
Measured: Baseline, Week 56
Change from Baseline in Waist Circumference
Measured: Baseline, Week 56
Percent Change from Baseline in Non-High-Density Lipoprotein (HDL) Cholesterol
Measured: Baseline, Week 56
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
Measured: Baseline through Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start17 Nov 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (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
- 250 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
- NCT07232719
- Sponsor's protocol ID
- 27769
- Other IDs
- J1I-MC-GZQJ
- Acronym
- TRIUMPH-8
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2025
- Last updated
- 17 Apr 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 17 Apr 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 Retatrutide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07232719
- Acronym / sponsor ID
- TRIUMPH-8 / 27769
- Conditions
- Obesity, Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 18 Nov 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.
The purpose of this study is to evaluate the efficacy and safety of retatrutide compared with placebo for body weight reduction.
Participation in the study will last about 65 weeks and may include about 18 visits.
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 subcutaneously (SC) |
| Retatrutide Dose 2 | Experimental | Drug: RetatrutideParticipants will receive retatrutide SC |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo 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) of:
- Have at least one unsuccessful attempt to lose weight by dieting
Key exclusion criteria (12 listed)
- Have a self-reported change in body weight >5 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 1, Retatrutide Dose 2 |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 56
4 secondary outcomes
Change from Baseline in Systolic Blood Pressure
Time frame: Baseline, Week 56
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 56
Percent Change from Baseline in Non-High-Density Lipoprotein (HDL) Cholesterol
Time frame: Baseline, Week 56
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
Time frame: Baseline through Week 56
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 17 Apr 2026.
- A Study of Retatrutide (LY3437943) in Participants with Obesity or Overweight (TRIUMPH-8)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
31 sites in 2 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 31 sites in 2 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 12 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, United Kingdom. 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: Baseline, Week 56). 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 17 Apr 2026.