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About
This study is being done to test the safety and efficacy of the study drug LY3556050 for the treatment of diabetic peripheral neuropathic pain. This trial is part of the chronic pain master protocol (H0P-MC-CPMP) which is a protocol to accelerate the development of new treatments for chronic pain.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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.
Are taking metformin therapy. Metformin Exception Limited dosages of metformin are allowed in this study. Additional exclusion criteria for participants taking metformin.
Primary purpose
Allocation
Interventional model
Masking
68 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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