A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain
- Conditions
- ObesityOverweightChronic Low Back Pain (CLBP)
- Interventions
- Drug: Placebo
- Registration Number
- NCT07035093
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 586
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Retatrutide Retatrutide Participants will receive Retatrutide subcutaneously (SC) Placebo Placebo Participants will receive Placebo SC
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in Waist Circumference Baseline, up to 72 weeks Change in Blood Pressure Baseline, up to 72 weeks Change in Glycemic Control Baseline, up to 72 weeks Number of Participants with Reduction in Body Weight 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 Number of Participants with Reduction in Pain Intensity Per Numeric Rating Scale Baseline, up to 72 weeks Change in Physical Function as Measured by Patient-Reported Outcomes Measurement Information Systems (PROMIS) Baseline, up to 72 weeks Percent Change in Total Cholesterol 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 Biomarkers of Inflammation as Measured by Blood Test Baseline, up to 72 weeks Percent Change in Urine Albumin-to-Creatinine Ratio (UACR) Baseline, up to 72 weeks
Trial Locations
- Locations (52)
MD First Research - Chandler
🇺🇸Chandler, Arizona, United States
Tucson Orthopaedic Institute - North Wyatt Drive
🇺🇸Tucson, Arizona, United States
Ark Clinical Research - Fountain Valley
🇺🇸Fountain Valley, California, United States
St Joseph Heritage Healthcare
🇺🇸Fullerton, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
K2 Medical Research - Daytona Beach
🇺🇸Daytona Beach, Florida, United States
Suncoast Research Group
🇺🇸Miami, Florida, United States
IMA Clinical Research St. Petersburg
🇺🇸Saint Petersburg, Florida, United States
Care Access - Tampa
🇺🇸Tampa, Florida, United States
Scroll for more (42 remaining)MD First Research - Chandler🇺🇸Chandler, Arizona, United StatesHemant PandeyPrincipal Investigator