RecruitingPhase 3NCT07035093
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight 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
Sponsor
Eli Lilly and Company
Enrollment
586 participants
Start Date
May 29, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria7
- 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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Interventions
DRUGRetatrutide
Administered SC
DRUGPlacebo
Administered SC
Locations(40)
View Full Details on ClinicalTrials.gov
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NCT07035093
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