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

Last updated: February 26, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Oral Facial Pain

Pain

Neuropathy

Treatment

Placebo

LY3848575

Clinical Study ID

NCT06568042
18825
2024-513435-24-00
J4F-MC-CYAB
  • Ages > 18
  • All Genders

Study Summary

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.

Participation may last up to 30 weeks including screening.

Eligibility Criteria

Inclusion

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 orautonomic features with gradual or insidious onset with a minimum duration of 6months and a known cause of nerve injury, such as metabolic, toxic exposure,nutritional, immunologic, infectious, hereditary, multifactorial, or no known causeidentified (idiopathic), of symmetrical nature and in lower extremities (with orwithout 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 newnonpharmacologic pain-relieving therapies and/or nutritional supplements duringstudy participation.

  • Are willing to discontinue all medications taken for chronic pain conditions, exceptthe allowed pain medications.

  • Individuals NOT of childbearing potential may participate in the trial.Contraceptive use by participants should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.

Exclusion

Exclusion Criteria:

  • Other etiologies of pain that may not be due to DSP or confound the assessment dueto painful DSP.

  • Have had a procedure within the past 6 months intended to produce permanent sensoryloss in the target area of interest.

  • Have not achieved glycemic control on a stable diabetes treatment regimen for atleast 90 days prior to screening, have a healthcare provider who manages theparticipants' 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 sensorypolyneuropathy.

  • Are, in the judgment of the investigator, actively suicidal and therefore deemed tobe 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 yearsprior to screening.

Study Design

Total Participants: 450
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
August 22, 2024
Estimated Completion Date:
September 30, 2026

Connect with a study center

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    Ostrava, Ostrava Město 702 00
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    Praha, Praha 4 14900
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    Westerstede, Niedersachsen 26655
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