Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Osteoarthritis
Condition: Osteoarthritis; Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Chronic 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: 160.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test safety and efficacy of study drug LY3526318 in for the
      treatment of knee pain due to with osteoarthritis (OA). 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.

          -  Have presence of index knee pain for >12 weeks at screening.

          -  Have an x-ray supporting diagnosis of osteoarthritis according to the American College
             of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of
             index knee.

          -  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.

          -  Are largely or wholly incapacitated and unable to participate fully in all protocol
             procedures, for example, bedridden or confined to a wheelchair, permitting little or
             no selfcare.

          -  Have presence of surgical hardware or other foreign body in the index knee.

          -  Have an unstable index joint (such as a torn anterior cruciate ligament).

          -  Have had a surgical procedure or therapeutic injection in the affected knee within 3
             months prior to starting the washout period.

          -  Have chronic pain syndrome, or other concurrent medical or arthritic conditions that
             could interfere with the evaluation of the index knee.

          -  Have a history of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis,
             ankylosing spondylitis, arthritis associated with inflammatory bowel disease,
             sarcoidosis, or amyloidosis.

          -  Have clinical signs and symptoms of active knee infection or crystal disease of the
             index knee.

          -  Have a history of infection in the index joint.

          -  Have a history of arthritis due to crystals (e.g., gout, pseudo gout).

          -  Have pain or functional impairment due to ipsilateral hip osteoarthritis.

          -  Are pregnant or breastfeeding.