Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain

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 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.
• •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.
• •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.
• •* Have a history or presence of lactic acidosis.
• •* Have a history or presence of severe hepatic disease including cirrhosis.
• •* Have uncontrolled or unstable congestive heart failure.
• •* Are taking carbonic anhydrase inhibitors if also taking metformin.
• •* Have had a change in metformin therapy in the last 12 weeks.
• •* Have not maintained a stable dose of glucose-lowering agents other than metformin before randomization.
• •* Are pregnant or breastfeeding.
• •* Have fibromyalgia.