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

Description

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.

Conditions

Neuropathic Pain, Distal Sensory Polyneuropathy

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Neuropathic Pain
Intervention / Treatment

-

Contacts and Locations

Chandler

MD First Research - Chandler, Chandler, Arizona, United States, 85286

Phoenix

Hope Research Institute, Phoenix, Arizona, United States, 85018

Fresno

Neuro-Pain Medical Center, Fresno, California, United States, 93710

Los Angeles

The Los Angeles Headache Center, Los Angeles, California, United States, 90067

Boulder

Alpine Clinical Research Center, Boulder, Colorado, United States, 80301

Aventura

First Choice Neurology - Aventura Neurology, Aventura, Florida, United States, 33180

Largo

Accel Research Sites Network - St. Pete-Largo Clinical Research Unit, Largo, Florida, United States, 33777

Miami Lakes

Design Neuroscience Center, Miami Lakes, Florida, United States, 33016

The Villages

Charter Research - Lady Lake, The Villages, Florida, United States, 32162

Weston

Encore Medical Research - Weston, Weston, Florida, United States, 33331

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2026-09