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Evaluating LY3848575 for nerve pain relief

A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study Evaluating LY3848575 in Chronic Neuropathic Pain Associated With Distal Sensory Polyneuropathy

Phase 2 Interventional Eli Lilly and Company · NCT06568042

This study is testing a new medication called LY3848575 to see if it can help people with nerve pain in their feet and legs feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionschemotherapy
Locations82 sites (Chandler, Arizona and 81 other locations)
Trial IDNCT06568042 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of LY3848575 compared to a placebo in individuals suffering from painful distal sensory polyneuropathy. Participants will be monitored over a period of up to 30 weeks, during which their pain levels will be evaluated using a Visual Analog Scale. The study focuses on patients with nerve pain that typically starts in the feet and may extend up the legs, ensuring a controlled environment by requiring participants to maintain their current pain management regimens. The trial seeks to provide insights into a potential new treatment option for neuropathic pain.

Who should consider this trial

Good fit: Ideal candidates are individuals experiencing painful distal sensory polyneuropathy with a pain score between 40 and 95 on the Visual Analog Scale.

Not a fit: Patients with non-painful neuropathy or those who do not meet the specific pain criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate nerve pain for patients suffering from distal sensory polyneuropathy.

How similar studies have performed: Previous studies on neuropathic pain treatments have shown promise, but the specific approach of LY3848575 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have a Visual Analog Scale (VAS) pain value ≥40 and \<95 at screening.
* Presence of painful distal sensory polyneuropathy (DSP) without prominent motor or autonomic features with gradual or insidious onset with a minimum duration of 6 months and a known cause of nerve injury, such as metabolic, toxic exposure, nutritional, immunologic, infectious, hereditary, multifactorial, or no known cause identified (idiopathic), of symmetrical nature and in lower extremities (with or without involvement of the hands).
* Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain- relieving therapies and/or nutritional supplements and will not start any new nonpharmacologic pain-relieving therapies and/or nutritional supplements during study participation.
* Are willing to discontinue all medications taken for chronic pain conditions, except the allowed pain medications.
* Individuals NOT of childbearing potential may participate in the trial. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

* Other etiologies of pain that may not be due to DSP or confound the assessment due to painful DSP.
* Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest.
* Have not achieved glycemic control on a stable diabetes treatment regimen for at least 90 days prior to screening, have a healthcare provider who manages the participants' diabetes, and have a hemoglobin A1c (HbA1c) \>11% at screening.
* Cancer within 2 years of baseline, except for:

  * cutaneous basal cell or squamous cell carcinoma resolved by excision, or
  * cancer treatment which led to chemotherapy that caused distal sensory polyneuropathy.
* Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
* Have a surgery planned during the study for any reason.
* History of chronic alcohol, illicit drug, or narcotic use disorder within 2 years prior to screening.

Where this trial is running

Chandler, Arizona and 81 other locations

+32 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 Neuropathic PainDistal Sensory PolyneuropathyPeripheral NeuropathyDiabetic Peripheral NeuropathyChemotherapy Induced Peripheral NeuropathyHIV Induced Peripheral Neuropathy
Last reviewed 2026-06-09 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.