The purpose of this study is to test the safety and efficacy of study drug LY4065967 for the treatment of diabetic peripheral neuropathic pain (DPNP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
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 (©University of Michigan)
Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
Have an HbA1c <11% and on a stable regimen for treatment of diabetes at least 90 days prior to screening
Have a body mass index at screening of ≤40 kilogram per meter squared (kg/m2)
Are pregnant or breastfeeding
Have a history of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to diabetic peripheral neuropathic pain (DPNP)
Have lower limb amputation due to diabetes inclusive of great toe (metatarsal bone)
Have serum vitamin B12 ≤200 picogram per milliliter (pg/mL)
Parallel
LY4065967
DrugAdministered orally
Placebo
DrugAdministered orally
Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score
Change from Baseline in Overall Improvement as Measured by Patient's Global Impression of Change (PGI-C)
Change from Baseline in Worst Pain Intensity as Measured by NRS
Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)
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