Actively Recruiting
Randomized, Placebo-Controlled Phase 2 Trial of LY4065967 for Diabetic Peripheral Neuropathic Pain
Led by Eli Lilly and Company · Updated on 2026-03-27
150
Participants Needed
37
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have diabetic peripheral neuropathy affecting both lower legs for 6 months or more, confirmed by a Michigan Neuropathy Screening Instrument score of 3 or higher
- Have a history and current diagnosis of type 1 or type 2 diabetes mellitus
- Have HbA1c less than 11% and stable diabetes treatment for at least 90 days before screening
- Have a body mass index (BMI) of 40 kg/m2 or less at screening
You will not qualify if you...
- Are pregnant or breastfeeding
- Have other causes of pain that may affect assessment of diabetic peripheral neuropathic pain
- Have had lower limb amputation including the great toe due to diabetes
- Have vitamin B12 levels of 200 pg/mL or lower
- Have abnormal blood pressure with systolic over 140 mm Hg and diastolic over 90 mm Hg at screening
- Have a history or current serious heart disease or conditions that could cause arrhythmia as judged by the investigator
- Have current electrolyte abnormalities related to heart risk
Research Team
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Physicians interested in becoming principal investigators please contact
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