Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Diabetic Peripheral Neuropathic Pain
Eli Lilly and Company
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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) Exclusion Criteria: * Are pregnant or breastfeeding * Have a history of other potentially c…
Interventions
- DrugLY4065967
Administered orally
- DrugPlacebo
Administered orally
Locations (37)
- Central Research AssociatesBirmingham, Alabama
- Synexus Clinical Research US, Inc.Phoenix, Arizona
- Arizona Research CenterPhoenix, Arizona
- Desert Oasis Healthcare Medical GroupPalm Springs, California
- Artemis Institute for Clinical ResearchRiverside, California
- Artemis Institute for Clinical ResearchSan Diego, California