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

  • STATUS
    Recruiting
  • End date
    Feb 29, 2024
  • participants needed
    200
  • sponsor
    Eli Lilly and Company
Updated on 25 November 2021

Summary

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.

Details
Condition Diabetic Peripheral Neuropathic Pain
Treatment Placebo, LY3556050
Clinical Study IdentifierNCT04707157
SponsorEli Lilly and Company
Last Modified on25 November 2021

Eligibility

Yes No Not Sure

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/m) (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 pain medications taken for chronic pain conditions for the duration of the study
Have daily symmetrical foot pain secondary to peripheral neuropathy present for at least 6 months and as diagnosed through use of the Michigan Neuropathy Screening Instrument Part B 3 (University of Michigan)
Have a history and current diagnosis of type 1 or type 2 diabetes mellitus
Have stable glycemic control as indicated by a glycated hemoglobin 11 at time of screening
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 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
Are pregnant or breastfeeding
Have fibromyalgia
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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