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Evaluating LY3556050 for pain relief in adults with diabetic neuropathy

A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study to Evaluate LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain

Phase 2 Interventional Eli Lilly and Company · NCT06074562

This study is testing a new medication called LY3556050 to see if it can help adults with diabetic nerve pain feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment410 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations70 sites (Chandler, Arizona and 69 other locations)
Trial IDNCT06074562 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of LY3556050 compared to a placebo in adults suffering from diabetic peripheral neuropathic pain (DPNP). Over approximately 24 weeks, participants will undergo three study periods to monitor their pain levels and overall response to the treatment. Eligible participants must have a stable diabetes condition and a history of neuropathic pain, ensuring a focused evaluation of the drug's impact on their symptoms.

Who should consider this trial

Good fit: Ideal candidates include adults with Type 1 or Type 2 diabetes who have been diagnosed with diabetic peripheral neuropathy and experience daily pain.

Not a fit: Patients without a history of diabetic peripheral neuropathy or those with uncontrolled diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate pain for patients with diabetic peripheral neuropathy.

How similar studies have performed: Previous studies have explored treatments for diabetic peripheral neuropathy, but the specific approach of LY3556050 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have a history and current diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) diagnosed for at least 6 months prior to screening.
* Have a stable glycemic control on stable diabetes treatment regimen for at least 90 days prior to day 1 with a hemoglobin A1c (HbA1c) ≤10 for T1D and HbA1c ≤11 for participants with T2D at time of screening.
* Have a history of daily peripheral neuropathic pain for at least 12 weeks based on participant report or medical history.
* Have a visual analog scale (VAS) pain value ≥40 and \<95 during screening.
* 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
* Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
* Are willing to discontinue all medications taken for chronic pain conditions, except allowed concomitant pain medication permitted per protocol, for the duration of the study

  * Have a body mass index ≤45 kilogram/square meter (kg/m²) (inclusive).
  * Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion Criteria:

* History of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to DPNP.
* Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques.
* Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
* Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
* Have in the judgement of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
* Have a positive HIV test result at screening.
* Have a surgery planned during the study for any reason.
* Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)

Where this trial is running

Chandler, Arizona and 69 other locations

+20 more sites — see ClinicalTrials.gov for the full list.

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 Neuropathy
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.