ObesityPhase 3TRIUMPH-7NCT07035093
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain
A Phase 3 study testing Retatrutide in people with Obesity and Overweight, run by Eli Lilly and Company at 40 sites in 4 countries.
Trial summary
The main purpose of this study is to evaluate the efficacy and safety of retatrutide in relieving chronic low back pain in participants who have obesity or overweight. Participation in the study will last about 80 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight, Chronic Low Back Pain (CLBP)
- 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
- 586 participants
- Where
- 40 sitesin 4 countries
- Study dates
- 29 May 2025to Sep 2027
- Phase
- Phase 3
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 history of axial-predominant low back pain
- Have pain that is restricted to the low back or with a referral pattern limited to the proximal legs
- Have a body mass index (BMI) ≥27 kilograms per square meter (kg/m2) at screening
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
Who cannot join
- Have a non-axial origin low back pain
- Have had botulinum or steroid injections to the spine within 1 year of screening
- Have had trigger point injection to the spine within 6 months of screening
- Have a self-reported change in body weight >5 kilograms (kg) (11 pounds) within 90 days prior to screening
- Have been taking drugs to promote body weight reduction, including over-the-counter medications, within 90 days prior to screening
- Have a prior or planned surgical treatment for obesity
- Have Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes
Trial locations and contacts
40 sites in 4 countries.
40 sites in 4 countries
United States25 sites
FutureSearch Trials of Neurology
Austin, Texas, 78731
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Alpine Clinical Research Center
Boulder, Colorado, 80301
MD First Research - Chandler
Chandler, Arizona, 85286
Mercy Family Clinic
Dallas, Texas, 75208
Sovah Clinical Research-River District
Danville, Virginia, 24541
K2 Medical Research - Daytona Beach
Daytona Beach, Florida, 32114
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
Ark Clinical Research - Fountain Valley
Fountain Valley, California, 92708
St Joseph Heritage Healthcare
Fullerton, California, 92835
Houston Research Institute
Houston, Texas, 77079
New Phase Research and Development
Knoxville, Tennessee, 37909
Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana, 70601
Clinical Research Institute
Los Angeles, California, 90048
Flourish Research - Miami, LLC
Miami, Florida, 33135
Artemis Institute for Clinical Research
San Diego, California, 92123
Clinvest Headlands Llc
Springfield, Missouri, 65807
IMA Clinical Research St. Petersburg
St. Petersburg, Florida, 33704
Care Access - Tampa
Tampa, Florida, 33625
Charter Research - Lady Lake
The Villages, Florida, 32162
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
Tucson Orthopaedic Institute - North Wyatt Drive
Tucson, Arizona, 85712
MedVadis Research Corporation
Waltham, Massachusetts, 02451
Center for Clinical Research
Winston-Salem, North Carolina, 27103
Conquest Research
Winter Park, Florida, 32789
Argentina9 sites
Investigaciones Medicas Imoba Srl
Buenos Aires, C1056ABH
CIPREC
Buenos Aires, C1061AAS
Centro Médico Viamonte
Buenos Aires, C1120AAC
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425AGC
Fundación Respirar
Buenos Aires, C1426ABP
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, 2152
Centro Rosarino de Investigaciones Clinicas (CRICs)
Rosario, 2000
Instituto Médico Catamarca IMEC
Rosario, 2000
Centro de Diagnóstico y Rehabilitación (CEDIR)
Santa Fe, 3000
Canada5 sites
Aggarwal and Associates Limited
Brampton, L6T 0G1
Winterberry Research Inc.
Hamilton, L8J 0B6
Bluewater Clinical Research Group Inc.
Sarnia, N7T 4X3
Care Access - Cape Breton
Sydney, B1M 0A1
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, M9V 4B4
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants Who Have Obesity or Overweight and Chronic Low Back Pain
The main purpose of this study is to evaluate the efficacy and safety of retatrutide in relieving chronic low back pain in participants who have obesity or overweight. Participation in the study will last about 80 weeks.
- Conditions
- Obesity, Overweight, Chronic Low Back Pain (CLBP)
- Being tested
- Retatrutide, Placebo
- Keywords
- Axial Predominant Low Back Pain
- 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 | Experimental | Participants will receive Retatrutide subcutaneously (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.
Change from Baseline in Pain Intensity Per Numeric Rating Scale
Measured: Baseline, up to 72 weeks
Percent Change from Baseline in Body Weight
Measured: Baseline, up to 72 weeks
Secondary outcomes (12)
Number of Participants with Reduction in Pain Intensity Per Numeric Rating Scale
Measured: Baseline, up to 72 weeks
Number of Participants with Reduction in Body Weight
Measured: Baseline, up to 72 weeks
Change in Physical Function as Measured by Patient-Reported Outcomes Measurement Information Systems (PROMIS)
Measured: Baseline, up to 72 weeks
Change in Pain Interference as Measured by PROMIS
Measured: Baseline, up to 72 weeks
Change in Sleep as Measured by PROMIS
Measured: Baseline, up to 72 weeks
Change in Patient Reported Health Outcomes as Measured by Medical Outcomes Study 36-item Short Form Health Survey version 2 (SF-36v2)
Measured: Baseline, up to 72 weeks
Change in Waist Circumference
Measured: Baseline, up to 72 weeks
Change in Biomarkers of Inflammation as Measured by Blood Test
Measured: Baseline, up to 72 weeks
Change in Blood Pressure
Measured: Baseline, up to 72 weeks
Change in Glycemic Control
Measured: Baseline, up to 72 weeks
Percent Change in Total Cholesterol
Measured: Baseline, up to 72 weeks
Percent Change in Urine Albumin-to-Creatinine Ratio (UACR)
Measured: Baseline, up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start29 May 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 586 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
- NCT07035093
- Sponsor's protocol ID
- 27278
- Other IDs
- J1I-MC-GZQD, 2024-517431-43-00
- Acronym
- TRIUMPH-7
- Status last verified
- Sep 2026
- First submitted
- 28 May 2025
- Last updated
- 25 Sep 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.