Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain
Condition: Diabetic Peripheral Neuropathic Pain
MeSH terms: Neuralgia; Diabetic Neuropathies
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: 155.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the safety and efficacy of study drug LY3526318 for the
      treatment of diabetic peripheral neuropathic pain (DPNP). 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 pain 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 had a procedure within the past 6 months intended to product 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 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 a substance use disorder as defined by the Diagnostic and Statistical Manual of
             Mental Disorders (5th edition; DSM-5; American Psychiatric Association).

          -  Have had cancer within 2 years of baseline, except for cutaneous basal cell or
             squamous cell carcinoma resolved by excision.

          -  Have fibromyalgia

          -  Are, in the judgment of the investigator, actively suicidal and therefore deemed to be
             at significant risk for suicide.

          -  Have a positive human immunodeficiency virus (HIV) test result at screening.

          -  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.

          -  Are pregnant or breastfeeding.