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Trial · Interventional

Active, not recruitingPhase 3Registry data

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

Short name TRIUMPH-7

NCTNCT07035093 (opens ClinicalTrials.gov in a new tab)Other id27278Other idJ1I-MC-GZQDOther id2024-517431-43-00
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
586 participants (estimated)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
4 countries

United States, Argentina, Canada, Poland

Start
29 May 2025
Primary completion
Sept 2027 (estimated)
Completion
Sept 2027 (estimated)
First posted
24 Jun 2025
Last update posted
25 Sept 2026
Conditions
Obesity · Overweight · Chronic Low Back Pain (CLBP)

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2025202620272028
  1. Ph 3

    TRIUMPH-7

    NCT07035093

    29 May 2025 to est. Sept 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • RetatrutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Retatrutide

    Participants will receive Retatrutide subcutaneously (SC)

  • Placebo comparator

    Placebo

    Participants will receive Placebo SC

Primary outcomes2

Outcomes the sponsor listed as primary.

  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(12)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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