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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGRetatrutide
Administered SC
DRUGPlacebo
Administered SC
Locations(46)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07035093
Related Trials
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
NCT0722568643 locations
Heart Health Study in Washington D.C. to Develop a Community-Based Behavioral Weight Loss Intervention
NCT019277831 location
Early Tracking of Childhood Health Determinants (ETCHED) Study
NCT034818291 location
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
NCT011434543 locations
First in Human Study in Subjects With Obesity, But Otherwise Healthy
NCT062522201 location