Chronic Low Back Pain (CLBP), Obesity, Overweight
Conditions
Keywords
Axial Predominant Low Back Pain
Brief 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.
Interventions
DRUGRetatrutide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Pain Intensity Per Numeric Rating Scale | Baseline, up to 72 weeks |
| Percent Change from Baseline in Body Weight | Baseline, up to 72 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Reduction in Pain Intensity Per Numeric Rating Scale | Baseline, up to 72 weeks |
| Number of Participants with Reduction in Body Weight | Baseline, up to 72 weeks |
| Change in Physical Function as Measured by Patient-Reported Outcomes Measurement Information Systems (PROMIS) | Baseline, up to 72 weeks |
| Change in Pain Interference as Measured by PROMIS | Baseline, up to 72 weeks |
| Change in Sleep as Measured by PROMIS | Baseline, up to 72 weeks |
| Change in Patient Reported Health Outcomes as Measured by Medical Outcomes Study 36-item Short Form Health Survey version 2 (SF-36v2) | Baseline, up to 72 weeks |
| Change in Waist Circumference | Baseline, up to 72 weeks |
| Change in Biomarkers of Inflammation as Measured by Blood Test | Baseline, up to 72 weeks |
| Change in Blood Pressure | Baseline, up to 72 weeks |
| Change in Glycemic Control | Baseline, up to 72 weeks |
| Percent Change in Total Cholesterol | Baseline, up to 72 weeks |
| Percent Change in Urine Albumin-to-Creatinine Ratio (UACR) | Baseline, up to 72 weeks |
Countries
Argentina, Canada, Poland, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed