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

Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Diabetic Peripheral Neuropathic Pain

Phase 2 Interventional Eli Lilly and Company · NCT07285018

This trial tests whether LY4065967 can safely reduce pain in adults with diabetic peripheral neuropathic pain.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations37 sites (Birmingham, Alabama and 36 other locations)
Trial IDNCT07285018 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with type 1 or type 2 diabetes who have had symmetrical lower-extremity diabetic peripheral neuropathic pain for ≥6 months, a Michigan Neuropathy Screening Instrument Part B score ≥3, HbA1c <11%, and BMI ≤40 while not pregnant or breastfeeding are the ideal candidates.

Not a fit: People with other causes of pain that could confound assessment, lower-limb amputation, low vitamin B12 (≤200 pg/mL), uncontrolled hypertension at screening, or who are pregnant or breastfeeding are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, LY4065967 could reduce neuropathic pain and improve function and quality of life for people with diabetic peripheral neuropathy.

How similar studies have performed: Other experimental drugs for diabetic peripheral neuropathic pain have produced mixed results in phase 2 and later trials, so this therapeutic approach remains promising but not yet proven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Birmingham, Alabama and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetic Peripheral Neuropathic Pain
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.