chronic pain master protocol (cpmp): a study of ly3556050 in participants with osteoarthritis

Conditions: Osteoarthritis

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.