Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: LY3016859; Placebo
Intervention description: Administered IV; Administered IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being done to test the safety and efficacy of the study drug LY3016859 for the
      treatment of chronic low back pain. 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 value of ≤30 on the pain catastrophizing scale.

          -  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.

          -  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.

          -  Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than
             or equal to 10 at time of screening.

          -  Are men, or women able to abide by reproductive and contraceptive requirements.

        Exclusion Criteria:

          -  Have second- or third-degree atrioventricular (AV) heart block or AV dissociation or
             history of ventricular tachycardia.

          -  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.

          -  There is an inability to rule out other causative or confounding sources of pain in
             the primary condition under study.

          -  Have had cancer within 2 years of baseline, except for cutaneous basal cell or
             squamous cell carcinoma resolved by excision.

          -  Have a substance use disorder as defined by the Diagnostic and Statistical Manual of
             Mental Disorders (5th edition; DSM-5; American Psychiatric Association).

          -  Have congenital QT prolongation or QT interval corrected for heart rate using
             Fridericia's formula (QTcF) interval measurement >450 milliseconds (msec) for male
             participants, >470 msec for female participants, or >480 msec for participants with
             bundle branch block.

          -  Have any clinically important abnormality at screening, as determined by investigator,
             in physical or neurological examination, vital signs, electrocardiogram (ECG), or
             clinical laboratory test results that could be detrimental to the participant or could
             compromise the study.

          -  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 spinal cord stimulator or dorsal root ganglion stimulator.

          -  Have fibromyalgia.