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A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain

NCT07641504

RecruitingPhase 2

Sponsor: Eli Lilly and Company

Conditions: Chronic Pain, Low Back Pain

Interventions: LY4065967, Placebo

Countries: United States, Puerto Rico

The main purpose of this study is to test the safety and efficacy of study drug for the treatment of chronic low back pain (CLBP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292), which is a protocol to accelerate the development of new treatments for chronic pain.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Have a history of low back pain for at least 3 months located between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation
* Have a body mass index at screening of ≤40 kilograms per meter squared (kg/m²).
* Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening

Exclusion Criteria:

* Are pregnant or breastfeeding
* Have used a therapeutic injection to the spine in the 3 months prior to screening
* Are using a spinal cord stimulator or dorsal root ganglion stimulator
* Have ongoing complex regional pain syndrome or other concurrent medical conditions that could interfere with the evaluation of CLBP
* Have a history of major spinal deformity, such as spondylolisthesis, spondylolysis, scoliosis, or spina bifida, that causes instability to the spine
* Have an abnormal blood pressure (BP) systolic BP is greater than 140 millimeters mercury (\>140 mm Hg) and diastolic BP\>90 mm Hg at screening • Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator
Locations (37)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Palm Springs, California, United States
  • Riverside, California, United States
  • San Diego, California, United States
  • Hamden, Connecticut, United States
  • Bradenton, Florida, United States
  • DeLand, Florida, United States
  • Lady Lake, Florida, United States
  • Maitland, Florida, United States
  • Merritt Island, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • New Port Richey, Florida, United States
  • Ocala, Florida, United States
  • Sunrise, Florida, United States
  • The Villages, Florida, United States
  • Winter Park, Florida, United States
  • Woodstock, Georgia, United States
  • Chicago, Illinois, United States
  • New Orleans, Louisiana, United States
  • New Bedford, Massachusetts, United States
  • Waltham, Massachusetts, United States
  • Bay City, Michigan, United States
  • City of Saint Peters, Missouri, United States
  • Springfield, Missouri, United States
  • Rochester, New York, United States
  • Fargo, North Dakota, United States
  • Dayton, Ohio, United States
  • + 7 more on CT.gov