CClinicalTrials.gg
Active, not recruitingNCT07035093TRIUMPH-7Updated Sep 25, 2026

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

A Phase 3 interventional study of Retatrutide and Placebo in Obesity, Overweight and Chronic Low Back Pain (CLBP), sponsored by Eli Lilly and Company. Active, not recruiting at 40 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
586
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Overweight
  • Chronic Low Back Pain (CLBP)

Keywords

  • Axial Predominant Low Back Pain
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 586 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
586 participants (estimated)

Study arms

  • Experimental
    Retatrutide

    Participants will receive Retatrutide subcutaneously (SC)

    Drug: Retatrutide

  • Placebo comparator
    Placebo

    Participants will receive Placebo SC

    Drug: Placebo

Interventions

  • DrugRetatrutide

    Administered SC

    Also known as: LY3437943

  • DrugPlacebo

    Administered SC

06

What researchers measure

Primary outcomes

  1. Change from Baseline in Pain Intensity Per Numeric Rating Scale

    Time frame: Baseline, up to 72 weeks

  2. Percent Change from Baseline in Body Weight

    Time frame: Baseline, up to 72 weeks

Secondary outcomes

  1. Number of Participants with Reduction in Pain Intensity Per Numeric Rating Scale

    Time frame: Baseline, up to 72 weeks

  2. Number of Participants with Reduction in Body Weight

    Time frame: Baseline, up to 72 weeks

  3. Change in Physical Function as Measured by Patient-Reported Outcomes Measurement Information Systems (PROMIS)

    Time frame: Baseline, up to 72 weeks

  4. Change in Pain Interference as Measured by PROMIS

    Time frame: Baseline, up to 72 weeks

  5. Change in Sleep as Measured by PROMIS

    Time frame: Baseline, up to 72 weeks

  6. 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

  7. Change in Waist Circumference

    Time frame: Baseline, up to 72 weeks

  8. Change in Biomarkers of Inflammation as Measured by Blood Test

    Time frame: Baseline, up to 72 weeks

  9. Change in Blood Pressure

    Time frame: Baseline, up to 72 weeks

  10. Change in Glycemic Control

    Time frame: Baseline, up to 72 weeks

  11. Percent Change in Total Cholesterol

    Time frame: Baseline, up to 72 weeks

  12. Percent Change in Urine Albumin-to-Creatinine Ratio (UACR)

    Time frame: Baseline, up to 72 weeks

07

Study locations

40 sites
  • 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
  • Podlaskie Centrum Psychogeriatrii
    Bialystok, 15-756, Poland
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Csr

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07035093
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Jun 24, 2025
Start date
May 29, 2025
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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