Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Diabetic Peripheral Neuropathic Pain
Condition: Diabetic Peripheral Neuropathic Pain
MeSH terms: Neuralgia; Diabetic Neuropathies
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: 125.0
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 diabetic peripheral neuropathic 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 daily symmetrical foot pain secondary to peripheral neuropathy present for at
             least 6 months and as diagnosed through use of the Michigan Neuropathy Screening
             Instrument Part B ≥3 (©University of Michigan).

          -  Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.

          -  Have stable glycemic control as indicated by a glycated hemoglobin ≤11 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 a current drug-induced neuropathy, for example, due to some types of
             chemotherapy, or other types of peripheral neuropathy.

          -  Have known hereditary motor, sensory or autonomic neuropathies.

          -  Have an estimated glomerular filtration rate (eGFR) of less than 70
             milliliters/minute/1.73m² during screening.

          -  Have any clinically serious or unstable cardiovascular, musculoskeletal disorder,
             gastrointestinal, endocrinologic, hematologic, hepatic, metabolic, urologic,
             pulmonary, dermatologic, immunologic, or ophthalmologic disease within 3 months of
             baseline.

          -  Have megaloblastic anemia or combined degeneration of the spinal cord.

          -  Have received any antibodies against nerve growth factor (NGF), or antibodies against
             EGFR, or EGFR tyrosine kinase inhibitors.

          -  Have a history of allergic reactions to monoclonal antibodies, or clinically
             significant multiple or severe drug allergies, including but not limited to erythema
             multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or
             exfoliative dermatitis.

          -  Have a history or presence of uncontrolled asthma, eczema, significant atopy,
             significant hereditary angio-edema or common variable immune deficiency.

          -  Have fibromyalgia