A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • LY4065967
  • Placebo

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators