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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
405
Mean Change from Baseline for Average Pain Intensity Numeric Rating Scale (API-NRS)
Time frame: Baseline, Week 12
Mean Change from Baseline for Worst Pain Intensity Numeric Rating Scale (WPI-NRS)
Time frame: Baseline, Week 12
Mean Change from Baseline for Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF)8a
Time frame: Baseline, Week 12
Mean Change from Baseline for Pain Interference with Sleep
Time frame: Baseline, Week 12
Mean Change from Baseline for PROMIS Physical Functioning Short Form (SF)10a
Time frame: Baseline, Week 12
Mean Change from Baseline for PROMIS Sleep Disturbance (SD)8b
Time frame: Baseline, Week 12
Mean Change from Baseline for Patient's Global Impression of Illness (PGI) Severity as Measured by PGI-Severity
Time frame: Baseline, Week 12
Mean Change from Baseline for Patient's Global Impression of Illness Status as Measured by PGI-Status
Time frame: Baseline, Week 12
Mean Change from Baseline for Patient's Global Impression of Change as Measured by PGI-Change
Time frame: Baseline, Week 12
Mean Change from Baseline for Neuropathy Total Symptom Score-6 (NTSS-6)
Time frame: Baseline, Week 12
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The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, United States
Orange Grove Family Practice
Tucson, Arizona, United States
Preferred Research Partners
Little Rock, Arkansas, United States
Hope Clinical Research, Inc.
Canoga Park, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Northern California Research - Sacramento
Sacramento, California, United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, United States
Suncoast Research Group
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
...and 60 more locations
Summary of Frequency, Timing and Amount of Rescue Medication Used During the Treatment Period
Time frame: Baseline to Week 12
Pharmacokinetics (PK): Plasma Concentration of LY3556050
Time frame: Baseline to Week 12