Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07035093

A Study of Retatrutide (LY3437943) 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Obesity Body Weight Chronic Low Back Pain (CLBP) Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CIPREC, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retatrutide

Drug

Administered SC

Other names: LY3437943

Placebo

Drug

Administered SC

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: TRIUMPH-7

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.