RECRUITING

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

Conditions

Neuropathic Pain Distal Sensory Polyneuropathy Peripheral Neuropathy Diabetic Peripheral Neuropathy Chemotherapy Induced Peripheral Neuropathy HIV Induced Peripheral Neuropathy

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-22

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06568042

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

CONTACT

3176154559

ClinicalTrials.gov@lilly.com

Principal Investigator

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 Locations (Sites)

MD First Research - Chandler

Chandler, Arizona, 85286

United States

Hope Research Institute

Phoenix, Arizona, 85018

United States

Neuro-Pain Medical Center

Fresno, California, 93710

United States

The Los Angeles Headache Center

Los Angeles, California, 90067

United States

Alpine Clinical Research Center

Boulder, Colorado, 80301

United States

First Choice Neurology - Aventura Neurology

Aventura, Florida, 33180

United States

Accel Research Sites Network - St. Pete-Largo Clinical Research Unit

Largo, Florida, 33777

United States

Design Neuroscience Center

Miami Lakes, Florida, 33016

United States

Charter Research - Lady Lake

The Villages, Florida, 32162

United States

Encore Medical Research - Weston

Weston, Florida, 33331

United States

Conquest Research

Winter Park, Florida, 32789

United States

Integrated Clinical Trial Services, Inc.

West Des Moines, Iowa, 50265

United States

Lucida Clinical Trials

New Bedford, Massachusetts, 02740

United States

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, 39157

United States

StudyMetrix Research

Saint Peters, Missouri, 63303

United States

Mid Hudson Medical Research

New Windsor, New York, 12553

United States

University of Rochester Medical Center

Rochester, New York, 14618

United States

Asheville Neurology Specialists, PA

Asheville, North Carolina, 28806

United States

Center for Clinical Research

Winston-Salem, North Carolina, 27103

United States

Neurology Diagnostics, Inc.

Dayton, Ohio, 45459

United States

New Phase Research and Development

Knoxville, Tennessee, 37909

United States

Cedar Health Research

Dallas, Texas, 75251

United States

Biopharma Informatic, LLC

Houston, Texas, 77043

United States

Clinical Trial Network

Houston, Texas, 77074

United States

Northwest Clinical Research Center

Bellevue, Washington, 98007

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-22

Study Completion Date2026-09

Study Record Updates

Study Start Date2024-08-22

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy
HIV Induced Peripheral Neuropathy

Additional Relevant MeSH Terms

Neuropathic Pain
Distal Sensory Polyneuropathy