A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain

Study Overview
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Brief Summary
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The main purpose of this study is to determine the safety and efficacy of LY3556050 versus placebo in participants with diabetic peripheral neuropathic pain (DPNP). The study will lasts approximately 24 weeks, across 3 study periods.

Official Title
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A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study to Evaluate LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain

Conditions
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Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Drug: LY3556050
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a history and current diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) diagnosed for at least 6 months prior to screening. Have a stable glycemic control on stable diabetes treatment regimen for at least 90 days prior to day 1 with a hemoglobin A1c (HbA1c) ≤10 at time of screening. Have a history of daily peripheral neuropathic pain for at least 12 weeks based on participant report or medical history. Have a visual analog scale (VAS) pain value ≥40 and <95 during screening. Have presence of diabetic peripheral neuropathy of symmetrical nature and in lower extremities for ≥6 months and diagnosed by a score of Part B ≥3 on Michigan Neuropathy Screening Instrument 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, except allowed concomitant pain medication permitted per protocol, for the duration of the study Have a body mass index ≤45 kilogram/square meter (kg/m²) (inclusive). Are men, or women able to abide by reproductive and contraceptive requirements. Exclusion Criteria: History of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to DPNP. 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 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 in the judgement 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 positive HIV test result at screening. Have a surgery planned during the study for any reason. Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)

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: LY3556050 Dose 1<br>Participants will receive LY3556050 orally. | Drug: LY3556050<br>* Administered orally.<br>|
| Experimental: LY3556050 Dose 2<br>Participants will receive LY3556050 orally. | Drug: LY3556050<br>* Administered orally.<br>|
| Experimental: LY3556050 Dose 3<br>Participants will receive LY3556050 orally. | Drug: LY3556050<br>* Administered orally.<br>|
| Placebo Comparator: Placebo<br>Participants will receive 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 |
| --- | --- | --- |
| Mean Change from Baseline for Average Pain Intensity Numeric Rating Scale (API-NRS) |  | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from Baseline for Worst Pain Intensity Numeric Rating Scale (WPI-NRS) |  | Baseline, Week 12 | 
| Mean Change from Baseline for Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF)8a |  | Baseline, Week 12 | 
| Mean Change from Baseline for Pain Interference with Sleep |  | Baseline, Week 12 | 
| Mean Change from Baseline for PROMIS Physical Functioning Short Form (SF)10a |  | Baseline, Week 12 | 
| Mean Change from Baseline for PROMIS Sleep Disturbance (SD)8b |  | Baseline, Week 12 | 
| Mean Change from Baseline for Patient's Global Impression of Illness (PGI) Severity as Measured by PGI-Severity |  | Baseline, Week 12 | 
| Mean Change from Baseline for Patient's Global Impression of Illness Status as Measured by PGI-Status |  | Baseline, Week 12 | 
| Mean Change from Baseline for Patient's Global Impression of Change as Measured by PGI-Change |  | Baseline, Week 12 | 
| Mean Change from Baseline for Neuropathy Total Symptom Score-6 (NTSS-6) |  | Baseline, Week 12 | 
| Summary of Frequency, Timing and Amount of Rescue Medication Used During the Treatment Period |  | Baseline to Week 12 | 
| Pharmacokinetics (PK): Plasma Concentration of LY3556050 |  | Baseline to Week 12 |