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Retatrutide for people with overweight or obesity and chronic low back pain

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

Phase 3 Interventional Eli Lilly and Company · NCT07035093

This trial will test whether retatrutide can reduce chronic low back pain in adults who are overweight or have obesity.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment586 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations41 sites (Chandler, Arizona and 40 other locations)
Trial IDNCT07035093 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized interventional trial compares retatrutide against placebo in adults with axial-predominant chronic low back pain and a body mass index of at least 27 kg/m2. Participants will be followed for about 80 weeks to monitor changes in pain, safety, and other outcomes such as weight. Key eligibility excludes people with diabetes, non-axial sources of back pain, recent spine injections, recent large weight changes, or recent use of weight-loss drugs. The sponsor is Eli Lilly and Company and the investigational drug has previously been studied for weight loss, with pain outcomes being a primary focus here.

Who should consider this trial

Good fit: Adults with axial-predominant chronic low back pain, BMI ≥27 kg/m2, a history of at least one unsuccessful dieting attempt, and without diabetes or recent spine injections may be appropriate candidates.

Not a fit: People with non-axial (radicular or other non-spinal) sources of back pain, diabetes, recent significant weight change, recent spine injections, planned obesity surgery, or recent use of weight-loss drugs are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If successful, retatrutide could reduce low back pain and improve function in people with overweight or obesity while also producing weight loss benefits.

How similar studies have performed: Other weight-loss drugs, including GLP-1 receptor agonists, have shown improvements in musculoskeletal pain in prior studies, but using retatrutide specifically for chronic low back pain is a novel application now being tested in a Phase 3 trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Chandler, Arizona and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ObesityOverweightChronic Low Back PainAxial Predominant Low Back Pain
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.