Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: LY3526318; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 159.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test whether LY3526318 is efficacious and safe in relieving
      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 criteria:

        Inclusion Criteria:

          -  Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.

          -  Have a history of daily pain for at least 12 weeks based on participant report or
             medical history.

          -  Have a body mass index <40 kilograms per meter squared (kg/m²) (inclusive).

          -  Are willing to maintain a consistent regimen of any ongoing nonpharmacologic
             pain-relieving therapies (for example, physical therapy) and will not start any new
             nonpharmacologic pain-relieving therapies during study participation.

          -  Are willing to discontinue all medications taken for chronic pain conditions for the
             duration of the study.

          -  Are at 18 years old or older at the time consent is signed.

          -  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 history of low back pain as classified by the Quebec Task Force Category 1
             through 3.

          -  Are men, or women able to abide by reproductive and contraceptive requirements.

        Exclusion Criteria:

          -  Have had a procedure within the past 6 months intended to produce permanent sensory
             loss in the target area of interest (for example, ablation techniques).

          -  Have surgery planned during the study for any reason, related or not to the disease
             state under evaluation.

          -  Have, in the judgment of the investigator, an acute, serious, or unstable medical
             condition or a history or presence of any other medical illness that would preclude
             study participation.

          -  Have had cancer within 2 years of baseline, except for cutaneous basal cell or
             squamous cell carcinoma resolved by excision.

          -  Have fibromyalgia

          -  Have a substance use disorder as defined by the Diagnostic and Statistical Manual of
             Mental Disorders (5th edition; DSM-5; American Psychiatric Association).

          -  Have a positive human immunodeficiency virus (HIV) test result at screening.

          -  Are, in the judgment of the investigator, actively suicidal and therefore deemed to be
             at significant risk for suicide.

          -  Have an intolerance to acetaminophen or paracetamol or any of its excipients.

          -  Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2
             years prior to screening.

          -  Have used a therapeutic injection (botulinum toxin or corticosteroids) in the 3 months
             prior to starting the washout period.

          -  Have history of or current compression fracture.

          -  Have had a recent major trauma (within 6 months of baseline).

          -  Have a history of low back pain as classified by the Quebec Task Force categories 4
             through 11.

          -  Are using a spinal cord stimulator or dorsal root ganglion stimulator.

          -  Are pregnant or breastfeeding.