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

Last updated: December 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

2

Condition

Acute 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

  • OCT Research ULC

    Kelowna, British Columbia V1Y 1Z9
    Canada

    Site Not Available

  • Richmond Clinical Trials

    Richmond, British Columbia V6V 2L1
    Canada

    Site Not Available

  • Med Trust Research

    Courtice, Ontario L1E 2J5
    Canada

    Site Not Available

  • Dawson Clinical Research

    Guelph, Ontario N1H 1B1
    Canada

    Active - Recruiting

  • Dawson Clinical Research Inc.

    Guelph, Ontario N1H 1B1
    Canada

    Site Not Available

  • Hamilton Medical Research Group

    Hamilton, Ontario L8M 1K7
    Canada

    Active - Recruiting

  • Premier Clinical Trial Network

    Hamilton, Ontario L8L5G4
    Canada

    Site Not Available

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • Genge Partners

    Montreal, Quebec H4A 3T2
    Canada

    Site Not Available

  • Med Trust Research

    Courtice 5930897, L1E 2J5
    Canada

    Site Not Available

  • Dawson Clinical Research Inc.

    Guelph 5967629, N1H 1B1
    Canada

    Site Not Available

  • Premier Clinical Trial Network

    Hamilton 5969782, L8L5G4
    Canada

    Site Not Available

  • OCT Research ULC

    Kelowna 5990579, V1Y 1Z9
    Canada

    Site Not Available

  • Genge Partners

    Montreal 6077243, H4A 3T2
    Canada

    Site Not Available

  • Richmond Clinical Trials

    Richmond 6122085, V6V 2L1
    Canada

    Site Not Available

  • Bluewater Clinical Research Group Inc.

    Sarnia 6141190, N7T 4X3
    Canada

    Site Not Available

  • MUDr. Alena Vachova

    Ceske Budejovice, Jihočeský Kraj 37011
    Czechia

    Site Not Available

  • MUDr. Miroslav Koliba s.r.o.

    Ostrava, Ostrava Město 702 00
    Czechia

    Site Not Available

  • NEUROS s.r.o.

    Pilsen, Plzeň-město 301 00
    Czechia

    Site Not Available

  • Milan Kvapil s.r.o., Diabetologicka ambulance

    Praha, Praha 4 14900
    Czechia

    Site Not Available

  • Milan Kvapil s.r.o., Diabetologicka ambulance

    Prague 3067696, 14900
    Czechia

    Site Not Available

  • Praglandia s.r.o

    Praha 5, 150 00
    Czechia

    Site Not Available

  • Studienzentrum Dr. Bischof GmbH

    Boeblingen, Baden-Württemberg 71034
    Germany

    Site Not Available

  • Studienzentrum Nord-West

    Westerstede, Niedersachsen 26655
    Germany

    Site Not Available

  • ZNS Siegen

    Siegen, Nordrhein-Westfalen 57076
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • emovis GmbH

    Berlin, 10629
    Germany

    Site Not Available

  • FutureMeds GmbH

    Berlin 2950159, 10629
    Germany

    Site Not Available

  • Studienzentrum Dr. Bischof GmbH

    Böblingen 2947444, 71034
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel 2891122, 24105
    Germany

    Site Not Available

  • ZNS Siegen

    Siegen 2832495, 57076
    Germany

    Site Not Available

  • Studienzentrum Nord-West

    Westerstede 2810188, 26655
    Germany

    Site Not Available

  • Kamezawa Clinic

    Kasugai, Aichi 486-0817
    Japan

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    Nagoya, Aichi 457-8511
    Japan

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  • Kikuchi Naika Clinic

    Maebashi, Gunma 370-3573
    Japan

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  • Nishinomiya Municipal Central Hospital

    Nishinomiya, Hyogo 663-8014
    Japan

    Site Not Available

  • Aizawa Hospital

    Matsumoto, Nagano 390-0814
    Japan

    Site Not Available

  • Asama General Hospital

    Saku, Nagano 385-0022
    Japan

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  • Rinku General Medical Center

    Izumisano, Osaka 598-8577
    Japan

    Site Not Available

  • Saga-Ken Medical Centre Koseikan

    Saga-shi, Saga 840-8571
    Japan

    Site Not Available

  • St. Luke's International Hospital

    Chuo-ku, Tokyo 104-8560
    Japan

    Site Not Available

  • The Cancer Institute Hospital of JFCR

    Koto, Tokyo 135-8550
    Japan

    Site Not Available

  • NTT Medical Center Tokyo

    Shinagawa-ku, Tokyo 141-8625
    Japan

    Site Not Available

  • St. Luke's International Hospital

    Chūōku 10262791, 104-8560
    Japan

    Site Not Available

  • Chugoku Central Hospital

    Fukuyama-shi, 720-0001
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    Site Not Available

  • Mito Medical Center

    Higashiibaraki, 311-3117
    Japan

    Site Not Available

  • Rinku General Medical Center

    Izumisano 1861091, 598-8577
    Japan

    Site Not Available

  • Sagara Hospital

    Kagoshima, 892-0833
    Japan

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  • Sagara Hospital

    Kagoshima 1860827, 892-0833
    Japan

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  • Kamezawa Clinic

    Kasugai 1859891, 486-0817
    Japan

    Site Not Available

  • The Cancer Institute Hospital of JFCR

    Kōtō City 11209896, 135-8550
    Japan

    Site Not Available

  • Kikuchi Naika Clinic

    Maebashi 1857843, 370-3573
    Japan

    Site Not Available

  • Aizawa Hospital

    Matsumoto 1857519, 390-0814
    Japan

    Site Not Available

  • Kojunkai Daido Hospital

    Nagoya 1856057, 457-8511
    Japan

    Site Not Available

  • Nishinomiya Municipal Central Hospital

    Nishinomiya 1855207, 663-8014
    Japan

    Site Not Available

  • Fujigaki Clinic

    Oita, 870-0942
    Japan

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  • Medical Corporation Sato Medical clinic

    Ootaku, 143-0015
    Japan

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  • Minamiosaka Hospital

    Osaka, 559-0012
    Japan

    Site Not Available

  • Minamiosaka Hospital

    Osaka 1853909, 559-0012
    Japan

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    Saga 1853303, 840-8571
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  • Asama General Hospital

    Saku 1853081, 385-0022
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    Shinagawa-ku, 140-8522
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  • Niwa Family Clinic

    Tokyo, 182-0006
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    Tokyo 1850147, 182-0006
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    Ōita 1854487, 870-0942
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  • Chosun University Hospital

    Gwangju, Kwangju-Kwangyǒkshi 61453
    Korea, Republic of

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    Seoul, Seoul-teukbyeolsi [Seoul] 05030
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul] 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul] 03722
    Korea, Republic of

    Active - Recruiting

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

    Seoul, Seoul-teukbyeolsi [Seoul] 06591
    Korea, Republic of

    Active - Recruiting

  • Grupo Medico Camino Sc

    Mexico City, Distrito Federal 03310
    Mexico

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  • Centro de Investigación Clínica y Medicina Traslacional (CIMeT)

    Guadalajara, Jalisco 44340
    Mexico

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  • Cicmex Centro de Investigación Clínica de México

    Morelia, Michoacán 58000
    Mexico

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  • Investigación Clínica Cuernavaca, S.C.

    Cuernavaca, Morelos 62448
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  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca de Juarez, Oaxaca 68020
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  • Health Pharma Querétaro

    Juriquilla, Querétaro 76230
    Mexico

    Site Not Available

  • Medical Care and Research SA de CV

    Merida, Yucatán 97070
    Mexico

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  • Scientia Investigacion Clinica S.C.

    Chihuahua, 31207
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    Chihuahua City 4014338, 31207
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  • Investigación Clínica Cuernavaca, S.C.

    Cuernavaca 3529947, 62448
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  • Centro de Investigación Clínica y Medicina Traslacional (CIMeT)

    Guadalajara 4005539, 44340
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  • Cicmex Centro de Investigación Clínica de México

    Morelia 3995402, 58000
    Mexico

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  • Medical Care and Research SA de CV

    Mérida 3523349, 97070
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  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City 3522507, 68020
    Mexico

    Site Not Available

  • Centrum Medyczne NEUROMED

    Bydgoszcz, Kujawsko-pomorskie 85-163
    Poland

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  • MICS Centrum Medyczne Warszawa

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  • Diamond Clinic

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  • Podlaskie Centrum Psychogeriatrii

    Białystok, Podlaskie 15-756
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  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomorskie 80-546
    Poland

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    Poznan, Wielkopolskie 61-853
    Poland

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    Katowice, Śląskie 40-749
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    Bialystok 776069, 15-756
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    Poland

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    Lodz 3093133, 90-302
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    Poznan 3088171, 61-853
    Poland

    Site Not Available

  • MICS Centrum Medyczne Warszawa

    Warsaw 756135, 00-874
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Warszawa - Chłodna

    Warsaw 756135, 00-872
    Poland

    Site Not Available

  • Chosun University Hospital

    Gwangju 1841811, 61453
    South Korea

    Site Not Available

  • Konkuk University Medical Center

    Seoul 1835848, 05030
    South Korea

    Site Not Available

  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Site Not Available

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

    Seoul 1835848, 06591
    South Korea

    Site Not Available

  • MD First Research - Chandler

    Chandler, Arizona 85286
    United States

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  • HOPE Research Institute

    Phoenix, Arizona 85032
    United States

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  • Hope Research Institute

    Phoenix, Arizona 85018
    United States

    Active - Recruiting

  • MD First Research - Chandler

    Chandler 5289282, Arizona 5551752 85286
    United States

    Site Not Available

  • HOPE Research Institute

    Phoenix 5308655, Arizona 5551752 85032
    United States

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  • Neuro-Pain Medical Center

    Fresno, California 93710
    United States

    Site Not Available

  • The Los Angeles Headache Center

    Los Angeles, California 90067
    United States

    Site Not Available

  • Neuro-Pain Medical Center

    Fresno 5350937, California 5332921 93710
    United States

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  • Alpine Clinical Research Center

    Boulder, Colorado 80301
    United States

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  • Alpine Clinical Research Center

    Boulder 5574991, Colorado 5417618 80301
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  • First Choice Neurology - Aventura Neurology

    Aventura, Florida 33180
    United States

    Site Not Available

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

    Largo, Florida 33777
    United States

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

    Largo, Florida 33777
    United States

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  • Design Neuroscience Center

    Miami Lakes, Florida 33016
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  • Conquest Research - Orlando

    Orlando, Florida 32832
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  • Charter Research - Lady Lake

    The Villages, Florida 32162
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  • Encore Medical Research - Weston

    Weston, Florida 33331
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  • Conquest Research

    Winter Park, Florida 32789
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    Site Not Available

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

    Largo 4161580, Florida 4155751 33777
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  • Design Neuroscience Center

    Miami Lakes 4164186, Florida 4155751 33016
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    Site Not Available

  • Conquest Research - Orlando

    Orlando 4167147, Florida 4155751 32832
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    Site Not Available

  • Charter Research - Lady Lake

    The Villages 4175179, Florida 4155751 32162
    United States

    Site Not Available

  • Encore Medical Research - Weston

    Weston 4178003, Florida 4155751 33331
    United States

    Site Not Available

  • Conquest Research

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • Integrated Clinical Trial Services, Inc.

    West Des Moines 4881346, Iowa 4862182 50265
    United States

    Site Not Available

  • Lucida Clinical Trials

    New Bedford, Massachusetts 02740
    United States

    Site Not Available

  • Lucida Clinical Trials

    New Bedford 4945121, Massachusetts 6254926 02740
    United States

    Site Not Available

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland 4443296, Mississippi 4436296 39157
    United States

    Site Not Available

  • StudyMetrix Research

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • StudyMetrix Research

    City of Saint Peters 4407237, Missouri 4398678 63303
    United States

    Site Not Available

  • Mid Hudson Medical Research

    New Windsor, New York 12553
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14618
    United States

    Site Not Available

  • Mid Hudson Medical Research

    New Windsor 5128577, New York 5128638 12553
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester 5134086, New York 5128638 14618
    United States

    Site Not Available

  • Asheville Neurology Specialists, PA

    Asheville, North Carolina 28806
    United States

    Site Not Available

  • Center for Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Asheville Neurology Specialists, PA

    Asheville 4453066, North Carolina 4482348 28806
    United States

    Site Not Available

  • Center for Clinical Research

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Site Not Available

  • Neurology Diagnostics, Inc.

    Dayton, Ohio 45459
    United States

    Site Not Available

  • Neurology Diagnostics, Inc.

    Dayton 4509884, Ohio 5165418 45459
    United States

    Site Not Available

  • New Phase Research and Development

    Knoxville, Tennessee 37909
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  • New Phase Research and Development

    Knoxville 4634946, Tennessee 4662168 37909
    United States

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  • Cedar Health Research

    Dallas, Texas 75251
    United States

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  • Biopharma Informatic, LLC

    Houston, Texas 77043
    United States

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  • Clinical Trial Network

    Houston, Texas 77074
    United States

    Active - Recruiting

  • Cedar Health Research

    Dallas 4684888, Texas 4736286 75251
    United States

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  • Biopharma Informatic, LLC

    Houston 4699066, Texas 4736286 77043
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  • Clinical Trial Network

    Houston 4699066, Texas 4736286 77074
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  • Northwest Clinical Research Center

    Bellevue, Washington 98007
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  • Northwest Clinical Research Center

    Bellevue 5786882, Washington 5815135 98007
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