Sponsor Name: Eli Lilly and Company
Protocol Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study Evaluating
LY3848575 in Chronic Neuropathic Pain Associated with Distal Sensory Polyneuropathy
Regulatory Agency Identifier Numbers: IND: 162737; EU trial number: 2024-513435-24-00
Rationale: Chronic neuropathic pain associated with DSP is the most common sub-type of generalized
polyneuropathy and typically presents in a stocking-glove distribution. The associated pain
symptoms may persist for many years, representing a significant impact in the quality of life due
to a multifaceted interference in walking ability, enjoyment of life, sleep, normal work, mood,
and general activity (FDA 2017; AAN 2019; Sachau et al. 2023).
Traditionally, painful DSP clinical trial populations have been defined by the etiology of nerve
damage, for example, diabetic peripheral neuropathy and chemotherapy-induced peripheral
neuropathy, and treatments have been evaluated in these separate disease states. A limited
number of studies have been conducted in other etiology-based DSPs, including idiopathic DSP,
for which no cause of the nerve damage is identified (Liampas et al. 2020). LY3848575 is not a
disease-modifying therapy designed to prevent or reverse the causes of painful DSP but targets
the painful symptoms associated with DSP. Using study entry criteria based upon clinical
features relevant to ongoing neuropathic pain will allow for evaluation of efficacy and safety in a
broader population with DSP.
Study CYAB is designed to evaluate the efficacy and safety of 3 dose levels of Q4W
administered LY3848575 compared with Q4W administered placebo in participants with painful
DSP. The primary objective is to demonstrate that at least 1 dose of LY3848575 is superior to
placebo at 12 weeks from randomization for average pain intensity as measured by the numeric
rating scale.