LY4065967 for diabetic peripheral neuropathic pain (part of a chronic pain master protocol)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 study, conducted under the H0P-MC-CPMP chronic pain master protocol, compares the experimental drug LY4065967 with placebo in adults who have diabetic peripheral neuropathic pain. Eligible participants must have symmetric lower-extremity neuropathy for at least six months and meet screening criteria including a Michigan Neuropathy Screening Instrument Part B score ≥3, HbA1c <11%, and BMI ≤40. The trial will collect safety data and measures of pain reduction at outpatient research sites in the U.S. sponsored by Eli Lilly to accelerate development of new chronic pain treatments.

Why it matters

Who can join: the full rules

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 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)
* Have an abnormal BP (systolic BP \>140 mm Hg and diastolic BP\>90 mm Hg) at screening
* Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator

Where it's running

• Central Research Associates
  Birmingham, Alabama, United States Recruiting
• Synexus Clinical Research US, Inc.
  Phoenix, Arizona, United States Recruiting
• Arizona Research Center
  Phoenix, Arizona, United States Recruiting
• Desert Oasis Healthcare Medical Group
  Palm Springs, California, United States Recruiting
• Artemis Institute for Clinical Research
  Riverside, California, United States Recruiting
• Artemis Institute for Clinical Research
  San Diego, California, United States Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• HRS-2129 for diabetic peripheral neuropathic pain

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• Suzetrigine for pain from diabetic peripheral neuropathy

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• Evaluating Suzetrigine for Pain from Diabetic Peripheral Neuropathy

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• Evaluating VX-993 for pain from diabetic nerve damage

  This study is testing if a new medication called VX-993 can help people with diabetes who have been dealing with pain in their legs and feet from nerve damage feel better compared to a standard treatment and a placebo.

  Recruiting at 22 sites Phase 2 Vertex Pharmaceuticals Incorporated · Cullman, Alabama and 46 other locations · NCT06619860

• Assessing a new spray treatment for diabetic nerve pain

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• Trimetazidine to help diabetic neuropathy symptoms and endothelin-1 levels

  This study tests whether taking trimetazidine can improve symptoms for adults with type 2 diabetes and diabetic peripheral neuropathy.

  Recruiting Phase 1/2 Ain Shams University · Cairo · NCT07794475

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.