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New drug aims to ease chronic nerve pain from polyneuropathy

NCT ID NCT06568042

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tests a new drug called LY3848575 for people with long-term nerve pain starting in the feet and moving up the legs. About 558 participants will receive either the drug or a placebo to see if it safely reduces pain. The trial lasts up to 30 weeks and measures pain intensity and sleep interference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY3848575
What this could lead to
If it works, this could provide a new option for easing chronic nerve pain in the feet and legs.
What could go wrong
This is a phase 2 dose-finding study, so it is still early. The drug may not reduce pain more than placebo, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

558 people

The number who actually took part.

Started

Aug 2024

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Largo, Florida, 33777, United States

  • Aizawa Hospital

    Matsumoto, 390-0814, Japan

  • Alpine Clinical Research Center

    Boulder, Colorado, 80301, United States

  • Asama General Hospital

    Saku, 385-0022, Japan

  • Asheville Neurology Specialists, PA

    Asheville, North Carolina, 28806, United States

  • Biopharma Informatic, LLC

    Houston, Texas, 77043, United States

  • Bluewater Clinical Research Group Inc.

    Sarnia, N7T 4X3, Canada

  • Cedar Health Research

    Dallas, Texas, 75251, United States

  • Center for Clinical Research

    Winston-Salem, North Carolina, 27103, United States

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, 68020, Mexico

  • Centro de Investigación Clínica y Medicina Traslacional (CIMeT)

    Guadalajara, 44340, Mexico

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, 80-546, Poland

  • Centrum Medyczne NEUROMED

    Bydgoszcz, 85-163, Poland

  • Charter Research - Lady Lake

    The Villages, Florida, 32162, United States

  • Chosun University Hospital

    Gwangju, 61453, South Korea

  • Chugoku Central Hospital

    Fukuyama-shi, 720-0001, Japan

  • Cicmex Centro de Investigación Clínica de México

    Morelia, 58000, Mexico

  • Clinical Trial Network

    Houston, Texas, 77074, United States

  • Conquest Research

    Winter Park, Florida, 32789, United States

  • Conquest Research - Orlando

    Orlando, Florida, 32832, United States

  • Dawson Clinical Research Inc.

    Guelph, N1H 1B1, Canada

  • Design Neuroscience Center

    Miami Lakes, Florida, 33016, United States

  • Diamond Clinic

    Krakow, 31-559, Poland

  • Encore Medical Research - Weston

    Weston, Florida, 33331, United States

  • Fujigaki Clinic

    Ōita, 870-0942, Japan

  • FutureMeds GmbH

    Berlin, 10629, Germany

  • Genge Partners

    Montreal, H4A 3T2, Canada

  • Grupo Medico Camino Sc

    Mexico City, 03310, Mexico

  • HOPE Research Institute

    Phoenix, Arizona, 85032, United States

  • Health Pharma Querétaro

    Juriquilla, 76230, Mexico

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265, United States

  • Investigación Clínica Cuernavaca, S.C.

    Cuernavaca, 62448, Mexico

  • Kamezawa Clinic

    Kasugai, 486-0817, Japan

  • Kikuchi Naika Clinic

    Maebashi, 370-3573, Japan

  • Kojunkai Daido Hospital

    Nagoya, 457-8511, Japan

  • Konkuk University Medical Center

    Seoul, 05030, South Korea

  • Lucida Clinical Trials

    New Bedford, Massachusetts, 02740, United States

  • MD First Research - Chandler

    Chandler, Arizona, 85286, United States

  • MICS Centrum Medyczne Warszawa - Chłodna

    Warsaw, 00-872, Poland

  • Med Trust Research

    Courtice, L1E 2J5, Canada

  • Medical Care and Research SA de CV

    Mérida, 97070, Mexico

  • Medical Corporation Sato Medical Clinic

    Ootaku, 143-0015, Japan

  • Mid Hudson Medical Research

    New Windsor, New York, 12553, United States

  • Minamiosaka Hospital

    Osaka, 559-0012, Japan

  • Mito Medical Center

    Higashiibaraki, 311-3117, Japan

  • Neuro-Care Sp. z o.o. sp. kom.

    Katowice, 40-749, Poland

  • Neuro-Pain Medical Center

    Fresno, California, 93710, United States

  • Neurology Diagnostics, Inc.

    Dayton, Ohio, 45459, United States

  • New Phase Research and Development

    Knoxville, Tennessee, 37909, United States

  • Nishinomiya Municipal Central Hospital

    Nishinomiya, 663-8014, Japan

  • Niwa Family Clinic

    Tokyo, 182-0006, Japan

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

    Poznan, 61-853, Poland

  • OCT Research ULC

    Kelowna, V1Y 1Z9, Canada

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756, Poland

  • Premier Clinical Trial Network

    Hamilton, L8L5G4, Canada

  • Richmond Clinical Trials

    Richmond, V6V 2L1, Canada

  • Rinku General Medical Center

    Izumisano, 598-8577, Japan

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi, 39157, United States

  • Saga-Ken Medical Centre Koseikan

    Saga, 840-8571, Japan

  • Sagara Hospital

    Kagoshima, 892-0833, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Santa Familia PTG Lodz

    Lodz, 90-302, Poland

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31207, Mexico

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • St. Luke's International Hospital

    Chūōku, 104-8560, Japan

  • Studienzentrum Dr. Bischof GmbH

    Böblingen, 71034, Germany

  • Studienzentrum Nord-West

    Westerstede, 26655, Germany

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303, United States

  • The Cancer Institute Hospital of JFCR

    Kōtō City, 135-8550, Japan

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul, 06591, South Korea

  • Tokyo Shinagawa Hospital

    Shinagawa-ku, 140-8522, Japan

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105, Germany

  • University of Rochester Medical Center

    Rochester, New York, 14618, United States

  • ZNS Siegen

    Siegen, 57076, Germany

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Other studies related to the condition(s) this trial covers.