Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy

Last updated: March 21, 2025
Sponsor: Eli Lily and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Neuropathy

Diabetic Neuropathy

Peripheral Neuropathy

Treatment

N/A

Clinical Study ID

TX400033
J4F-MC-CYAB
  • Ages 40-95
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

<p>Inclusion Criteria:</p><ul><li>Have a Visual Analog Scale (VAS) pain value ≥40 and &lt;95 at screening.</li><li>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.</li><li>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.</li><li>Are willing to discontinue all medications taken for chronic pain conditions, except the allowed pain medications.</li><li>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.</li></ul

Exclusion

><p>Exclusion Criteria:</p><ul><li>History of other potential causative and/or confounding sources of pain that may impair self-assessment of pain due to painful DSP.</li><li>Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest.</li><li>Have not achieved glycemic control on a stable diabetes treatment regimen for at least 90 days prior to screening and have a hemoglobin A1c (HbA1c) &gt;11 at screening.</li><li>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-induced peripheral neuropathy.</li><li>Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.</li><li>Have a surgery planned during the study for any reason.</li><li>History of chronic alcohol, illicit drug, or narcotic use disorder within 2 years prior to screening.</li></ul>

Study Design

Study Start date:
Estimated Completion Date:

Study Description

<p>The purpose of this study is to evaluate how safe and how well a treatment works compared to placebo for people with nerve pain that begins in their feet and moves up the leg to just below the knee.</p><p>Participation may last up to 30 weeks including screening.</p>

Connect with a study center

  • Mid Hudson Medical Research, PLLC

    New Windsor, New York 12553
    United States

    Active - Recruiting

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