A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain
TRIUMPH-7
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
3 other identifiers
interventional
586
5 countries
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 obesity
Started May 2025
Typical duration for phase_3 obesity
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2025
CompletedStudy Start
First participant enrolled
May 29, 2025
CompletedFirst Posted
Study publicly available on registry
June 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
April 17, 2026
April 1, 2026
2.3 years
May 28, 2025
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline in Pain Intensity Per Numeric Rating Scale
Baseline, up to 72 weeks
Percent Change from Baseline in Body Weight
Baseline, up to 72 weeks
Secondary Outcomes (12)
Number of Participants with Reduction in Pain Intensity Per Numeric Rating Scale
Baseline, up to 72 weeks
Number of Participants with Reduction in Body Weight
Baseline, up to 72 weeks
Change in Physical Function as Measured by Patient-Reported Outcomes Measurement Information Systems (PROMIS)
Baseline, up to 72 weeks
Change in Pain Interference as Measured by PROMIS
Baseline, up to 72 weeks
Change in Sleep as Measured by PROMIS
Baseline, up to 72 weeks
- +7 more secondary outcomes
Study Arms (2)
Retatrutide
EXPERIMENTALParticipants will receive Retatrutide subcutaneously (SC)
Placebo
PLACEBO COMPARATORParticipants will receive Placebo SC
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
MD First Research - Chandler
Chandler, Arizona, 85286, United States
Tucson Orthopaedic Institute - North Wyatt Drive
Tucson, Arizona, 85712, United States
Ark Clinical Research - Fountain Valley
Fountain Valley, California, 92708, United States
St Joseph Heritage Healthcare
Fullerton, California, 92835, United States
Clinical Research Institute
Los Angeles, California, 90048, United States
Artemis Institute for Clinical Research
San Diego, California, 92123, United States
Alpine Clinical Research Center
Boulder, Colorado, 80301, United States
K2 Medical Research - Daytona Beach
Daytona Beach, Florida, 32114, United States
Flourish Research - Miami, LLC
Miami, Florida, 33135, United States
IMA Clinical Research St. Petersburg
St. Petersburg, Florida, 33704, United States
Care Access - Tampa
Tampa, Florida, 33625, United States
Charter Research - Lady Lake
The Villages, Florida, 32162, United States
Conquest Research
Winter Park, Florida, 32789, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana, 70601, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
Clinvest Headlands Llc
Springfield, Missouri, 65807, United States
Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
New Phase Research and Development
Knoxville, Tennessee, 37909, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
Mercy Family Clinic
Dallas, Texas, 75208, United States
Houston Research Institute
Houston, Texas, 77079, United States
Sovah Clinical Research-River District
Danville, Virginia, 24541, United States
Investigaciones Medicas Imoba Srl
Buenos Aires, C1056ABH, Argentina
CIPREC
Buenos Aires, C1061AAS, Argentina
Centro Médico Viamonte
Buenos Aires, C1120AAC, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425AGC, Argentina
Fundación Respirar
Buenos Aires, C1426ABP, Argentina
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, 2152, Argentina
Centro Rosarino de Investigaciones Clinicas (CRICs)
Rosario, 2000, Argentina
Instituto Médico Catamarca IMEC
Rosario, 2000, Argentina
Centro de Diagnóstico y Rehabilitación (CEDIR)
Santa Fe, 3000, Argentina
Aggarwal and Associates Limited
Brampton, L6T 0G1, Canada
Winterberry Research Inc.
Hamilton, L8J 0B6, Canada
Bluewater Clinical Research Group Inc.
Sarnia, N7T 4X3, Canada
Care Access - Cape Breton
Sydney, B1M 0A1, Canada
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, M9V 4B4, Canada
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero, 89440, Mexico
Podlaskie Centrum Psychogeriatrii
Bialystok, 15-756, Poland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2025
First Posted
June 24, 2025
Study Start
May 29, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.