A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05)

Study Overview
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Brief Summary
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This study is being done to test the safety and efficacy of the study drug LY3857210 for the treatment of diabetic peripheral neuropathic pain.

Official Title
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A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain

Conditions
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Chronic Pain, Diabetic Peripheral Neuropathic Pain, Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Drug: LY3857210
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females may participate in this trial. No male contraception is required except in compliance with specific local government study requirements. Women of child bearing potential (WOCBP) and women not of child bearing potential (WNOCBP) may participate in this trial. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: Have a seizure disorder, history of seizure (other than remote history of childhood febrile seizure), or a condition that would place the participant at increased risk of seizure, such as head injury (for example, skull fracture, cerebral contusion, concussion, or trauma resulting in prolonged unconsciousness), intracranial neoplasm or hemorrhage. Have an eGFR of <30 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at Day 1 or Day 2. evidence of Hepatitis B virus or Hepatitis C virus. Women who are pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3857210<br>Participants will be given LY3857210 orally. | Drug: LY3857210<br>* Administered orally<br>|
| Placebo Comparator: Placebo<br>Participants will be given placebo orally. | Drug: Placebo<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) |  | Baseline, Up to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Total Interference Score |  | Baseline, Up to Week 8 | 
| Change from Baseline for Overall Improvement as Measured by Patient's Global Impression of Change |  | Baseline, Up to Week 8 | 
| Change from Baseline for Worst Pain Intensity as Measured by NRS |  | Baseline, Up to Week 8 | 
| Change from Baseline on the Visual Analog Scale (VAS) for Pain |  | Baseline, Up to Week 8 | 
| Change from Baseline on the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale) |  | Baseline, Up to Week 8 | 
| Change from Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) |  | Baseline, Up to Week 8 |