Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: LY3556050; Placebo
Intervention description: LY3556050 Given orally; Placebo Given orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 202.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This study is being done to test the safety and efficacy of LY3556050 for the treatment of
      osteoarthritis 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 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 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.

          -  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 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 fibromyalgia, 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, pseudogout).

          -  Have pain or functional impairment due to ipsilateral hip osteoarthritis.

          -  Have a history within 2 years prior to screening or current evidence of syncope,
             presyncope, uncontrolled vertigo, or postural dizziness, judged to be clinically
             significant by the investigator.

          -  Have clinically significant active thyroid disease, including Hashimoto's thyroiditis.

          -  Are taking metformin therapy.

          -  Are pregnant or breastfeeding.

          -  Have had any joint replacement such as knee of the lower extremity, such as hip, knee
             or ankle, in the past 6 months.