A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain (TRIUMPH-7)

July 22, 2026 updated by: Eli Lilly and Company

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

586

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Fundación Respirar
      • Buenos Aires, Argentina, C1120AAC
        • Centro Médico Viamonte
      • Buenos Aires, Argentina, C1061AAS
        • CIPREC
      • Buenos Aires, Argentina, C1425AGC
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
      • Buenos Aires, Argentina, C1056ABH
        • Investigaciones Medicas Imoba Srl
      • Granadero Baigorria, Argentina, 2152
        • Centro de Investigaciones Clinicas Baigorria
      • Rosario, Argentina, 2000
        • Instituto Médico Catamarca IMEC
      • Rosario, Argentina, 2000
        • Centro Rosarino de Investigaciones Clinicas (CRICs)
      • Santa Fe, Argentina, 3000
        • Centro de Diagnóstico y Rehabilitación (CEDIR)
  • Canada
      • Brampton, Canada, L6T 0G1
        • Aggarwal and Associates Limited
      • Hamilton, Canada, L8J 0B6
        • Winterberry Research Inc.
      • Sarnia, Canada, N7T 4X3
        • Bluewater Clinical Research Group Inc.
      • Sydney, Canada, B1M 0A1
        • Care Access - Cape Breton
      • Toronto, Canada, M9V 4B4
        • Dr. Anil K. Gupta Medicine Professional Corporation
  • Poland
      • Bialystok, Poland, 15-756
        • Podlaskie Centrum Psychogeriatrii
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85286
        • MD First Research - Chandler
      • Tucson, Arizona, United States, 85712
        • Tucson Orthopaedic Institute - North Wyatt Drive
    • California
      • Fountain Valley, California, United States, 92708
        • ARK Clinical Research - Fountain Valley
      • Fullerton, California, United States, 92835
        • St Joseph Heritage Healthcare
      • Los Angeles, California, United States, 90048
        • Clinical Research Institute
      • San Diego, California, United States, 92123
        • Artemis Institute for Clinical Research
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Alpine Clinical Research Center
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • K2 Medical Research - Daytona Beach
      • Miami, Florida, United States, 33135
        • Flourish Research - Miami, LLC
      • St. Petersburg, Florida, United States, 33704
        • IMA Clinical Research St. Petersburg
      • Tampa, Florida, United States, 33625
        • Care Access - Tampa
      • The Villages, Florida, United States, 32162
        • Charter Research - Lady Lake
      • Winter Park, Florida, United States, 32789
        • Conquest Research
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Care Access - Lake Charles (Bayou Pines)
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • MedVadis Research Corporation
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group, Inc.
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest Headlands Llc
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Center for Clinical Research
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • New Phase Research and Development
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology
      • Dallas, Texas, United States, 75208
        • Mercy Family Clinic
      • Houston, Texas, United States, 77079
        • Houston Research Institute
    • Virginia
      • Danville, Virginia, United States, 24541
        • Sovah Clinical Research-River District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive Placebo SC
Drug: Placebo
Administered SC
Experimental: Retatrutide
Participants will receive Retatrutide subcutaneously (SC)
Drug: Retatrutide
Administered SC
Other Names:
  • LY3437943

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Pain Intensity Per Numeric Rating Scale
Time Frame: Baseline, up to 72 weeks
Baseline, up to 72 weeks
Percent Change from Baseline in Body Weight
Time Frame: Baseline, up to 72 weeks
Baseline, up to 72 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Reduction in Pain Intensity Per Numeric Rating Scale
Time Frame: Baseline, up to 72 weeks
Baseline, up to 72 weeks
Number of Participants with Reduction in Body Weight
Time Frame: Baseline, up to 72 weeks
Baseline, up to 72 weeks
Change in Physical Function as Measured by Patient-Reported Outcomes Measurement Information Systems (PROMIS)
Time Frame: Baseline, up to 72 weeks
Baseline, up to 72 weeks
Change in Pain Interference as Measured by PROMIS
Time Frame: Baseline, up to 72 weeks
Baseline, up to 72 weeks
Change in Sleep as Measured by PROMIS
Time Frame: Baseline, up to 72 weeks
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)
Time Frame: Baseline, up to 72 weeks
Baseline, up to 72 weeks
Change in Waist Circumference
Time Frame: Baseline, up to 72 weeks
Baseline, up to 72 weeks
Change in Biomarkers of Inflammation as Measured by Blood Test
Time Frame: Baseline, up to 72 weeks
Baseline, up to 72 weeks
Change in Blood Pressure
Time Frame: Baseline, up to 72 weeks
Baseline, up to 72 weeks
Change in Glycemic Control
Time Frame: Baseline, up to 72 weeks
Baseline, up to 72 weeks
Percent Change in Total Cholesterol
Time Frame: Baseline, up to 72 weeks
Baseline, up to 72 weeks
Percent Change in Urine Albumin-to-Creatinine Ratio (UACR)
Time Frame: Baseline, up to 72 weeks
Baseline, up to 72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 28, 2025

First Submitted That Met QC Criteria

June 16, 2025

First Posted (Actual)

June 24, 2025

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 22, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27278
  • 2024-517431-43-00 (Ctis)
  • J1I-MC-GZQD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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