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

Eli Lilly and Company
ClinicalTrials.gov ยท June 24, 2025
Plain-language summary

Registered Phase 3 interventional trial (recruiting). 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.

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Trial record

Registered clinical trial record on ClinicalTrials.gov (NCT07035093). This describes a planned, ongoing, or completed study โ€” it is NOT peer-reviewed results. Status: recruiting. Study type: interventional. Phase: Phase 3. Sponsor: Eli Lilly and Company. Conditions: Obesity, Overweight, Chronic Low Back Pain (CLBP). Interventions: Retatrutide, Placebo. 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. Primary outcome measures: Change from Baseline in Pain Intensity Per Numeric Rating Scale; Percent Change from Baseline in Body Weight. Eligibility: 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) โ‰ฅ27 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

This is a registered clinical-trial record from ClinicalTrials.gov โ€” a description of a planned, ongoing, or completed study, not peer-reviewed results. Listing on ClinicalTrials.gov does not mean the study has been evaluated by the U.S. Federal Government, nor does it imply endorsement or that the intervention is safe or effective.

Educational summary of published research โ€” not medical advice. License: public-domain. Full text is shown only where licensing permits.