Randomized, Placebo-Controlled Phase 2 Trial of LY4065967 for Diabetic Peripheral Neuropathic Pain

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the drug LY4065967 for treating diabetic peripheral neuropathic pain (DPNP), which is pain caused by nerve damage due to diabetes. This trial is part of a larger chronic pain master protocol aimed at speeding up the development of new treatments for chronic pain conditions. The study is a randomized, placebo-controlled Phase 2 clinical trial sponsored by Eli Lilly and Company. Participants in this study will be randomly assigned to receive either LY4065967 or a placebo, both taken by mouth. The treatment period includes regular dosing, and the study compares the effects of the drug against placebo to assess its impact on pain relief. The trial uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo during the study. During the trial, participants will have their pain intensity tracked using the Numeric Rating Scale, along with other assessments such as sleep quality, emotional functioning, and pain interference with daily activities. These evaluations will occur from baseline through week 8 to monitor changes. Researchers will also measure the use of rescue medication and overall patient improvement. Safety monitoring and follow-up will be part of the study to ensure participant well-being throughout the trial duration.

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