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

April 24, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

558

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Courtice, Canada, L1E 2J5
        • Med Trust Research
      • Guelph, Canada, N1H 1B1
        • Dawson Clinical Research Inc.
      • Hamilton, Canada, L8L5G4
        • Premier Clinical Trial Network
      • Kelowna, Canada, V1Y 1Z9
        • OCT Research ULC
      • Montreal, Canada, H4A 3T2
        • Genge Partners
      • Richmond, Canada, V6V 2L1
        • Richmond Clinical Trials
      • Sarnia, Canada, N7T 4X3
        • Bluewater Clinical Research Group Inc.
  • Germany
      • Berlin, Germany, 10629
        • FutureMeds GmbH
      • Böblingen, Germany, 71034
        • Studienzentrum Dr. Bischof GmbH
      • Kiel, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel
      • Siegen, Germany, 57076
        • ZNS Siegen
      • Westerstede, Germany, 26655
        • Studienzentrum Nord-West
  • Japan
      • Chūōku, Japan, 104-8560
        • St. Luke's International Hospital
      • Fukuyama-shi, Japan, 720-0001
        • Chugoku Central Hospital
      • Higashiibaraki, Japan, 311-3117
        • Mito Medical Center
      • Izumisano, Japan, 598-8577
        • Rinku General Medical Center
      • Kagoshima, Japan, 892-0833
        • Sagara Hospital
      • Kasugai, Japan, 486-0817
        • Kamezawa Clinic
      • Kōtō City, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR
      • Maebashi, Japan, 370-3573
        • Kikuchi Naika Clinic
      • Matsumoto, Japan, 390-0814
        • Aizawa Hospital
      • Nagoya, Japan, 457-8511
        • Kojunkai Daido Hospital
      • Nishinomiya, Japan, 663-8014
        • Nishinomiya Municipal Central Hospital
      • Ootaku, Japan, 143-0015
        • Medical Corporation Sato Medical clinic
      • Osaka, Japan, 559-0012
        • Minamiosaka Hospital
      • Saga, Japan, 840-8571
        • Saga-ken Medical Centre Koseikan
      • Saku, Japan, 385-0022
        • Asama General Hospital
      • Shinagawa-ku, Japan, 140-8522
        • Tokyo Shinagawa Hospital
      • Tokyo, Japan, 182-0006
        • Niwa Family Clinic
      • Ōita, Japan, 870-0942
        • Fujigaki Clinic
  • Mexico
      • Chihuahua City, Mexico, 31207
        • Scientia Investigacion Clinica S.C.
      • Cuernavaca, Mexico, 62448
        • Investigación Clínica Cuernavaca, S.C.
      • Guadalajara, Mexico, 44340
        • Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
      • Juriquilla, Mexico, 76230
        • Health Pharma Querétaro
      • Mexico City, Mexico, 03310
        • Grupo Medico Camino Sc
      • Morelia, Mexico, 58000
        • Cicmex Centro de Investigación Clínica de México
      • Mérida, Mexico, 97070
        • Medical Care and Research SA de CV
      • Oaxaca City, Mexico, 68020
        • Centro de Investigacion Clinica de Oaxaca
  • Poland
      • Bialystok, Poland, 15-756
        • Podlaskie Centrum Psychogeriatrii
      • Bydgoszcz, Poland, 85-163
        • Centrum Medyczne Neuromed
      • Gdansk, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
      • Katowice, Poland, 40-749
        • Neuro-Care Sp. z o.o. sp. kom.
      • Krakow, Poland, 31-559
        • Diamond Clinic
      • Lodz, Poland, 90-302
        • Santa Familia PTG Lodz
      • Poznan, Poland, 61-853
        • Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
      • Warsaw, Poland, 00-872
        • MICS Centrum Medyczne Warszawa - Chłodna
  • South Korea
      • Gwangju, South Korea, 61453
        • Chosun university hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 06591
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
      • Seoul, South Korea, 05030
        • Konkuk University Medical Center
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85286
        • MD First Research - Chandler
      • Phoenix, Arizona, United States, 85032
        • Hope Research Institute
    • California
      • Fresno, California, United States, 93710
        • Neuro-Pain Medical Center
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Alpine Clinical Research Center
    • Florida
      • Largo, Florida, United States, 33777
        • Accel Research Sites - St. Pete-Largo Clinical Research Unit
      • Miami Lakes, Florida, United States, 33016
        • Design Neuroscience Center
      • Orlando, Florida, United States, 32832
        • Conquest Research - Orlando
      • The Villages, Florida, United States, 32162
        • Charter Research - Lady Lake
      • Weston, Florida, United States, 33331
        • Encore Medical Research - Weston
      • Winter Park, Florida, United States, 32789
        • Conquest Research
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Integrated Clinical Trial Services, Inc.
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
        • Lucida Clinical Trials
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • SKY Integrative Medical Center/SKYCRNG
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
    • New York
      • New Windsor, New York, United States, 12553
        • Mid Hudson Medical Research
      • Rochester, New York, United States, 14618
        • University of Rochester Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Asheville Neurology Specialists, PA
      • Winston-Salem, North Carolina, United States, 27103
        • Center for Clinical Research
    • Ohio
      • Dayton, Ohio, United States, 45459
        • Neurology Diagnostics, Inc.
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • New Phase Research and Development
    • Texas
      • Dallas, Texas, United States, 75251
        • Cedar Health Research
      • Houston, Texas, United States, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered SC.
Drug: Placebo
Administered SC
Experimental: LY3848575 Dose 1
LY3848575 low dose administered subcutaneously (SC).
Drug: LY3848575
Administered SC
Experimental: LY3848575 Dose 2
LY3848575 mid dose administered SC.
Drug: LY3848575
Administered SC
Experimental: LY3848575 Dose 3
LY3848575 high dose administered SC.
Drug: LY3848575
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS)
Time Frame: Baseline, Week 12
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS)
Time Frame: Baseline, Week 12
Baseline, Week 12
Mean Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Custom Form (CF) v1.1
Time Frame: Baseline, Week 12
Baseline, Week 12
Mean Change from Baseline in Pain Interference with Sleep
Time Frame: Baseline, Week 12
Baseline, Week 12
Mean Change from Baseline in PROMIS Short Form (SF) Physical Functioning (PF) 10a (PROMIS PF 10a)
Time Frame: Baseline, Week 12
Baseline, Week 12
Mean Change from Baseline in PROMIS (SF) Sleep Disturbance 8b (PROMIS SD 8b)
Time Frame: Baseline, Week 12
Baseline, Week 12
Mean Change from Baseline in 36-Item Short Form Health Survey Version 2 (SF-36 v2)
Time Frame: Baseline, Week 12
Baseline, Week 12
Mean Change from Baseline in Patient's Global Impression (PGI) of Illness Severity as Measured by PGI-Severity
Time Frame: Baseline, Week 12
Baseline, Week 12
Mean Overall Improvement as Measured by Patient's Global Impression of Change
Time Frame: Week 12
Week 12
Use of Rescue Medication
Time Frame: Baseline up to Week 12
Baseline up to Week 12
Pharmacokinetic (PK): Serum Concentration of LY3848575
Time Frame: Baseline up to Week 12
Baseline up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

August 22, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18825 (Arthritis Research UK)
  • J4F-MC-CYAB (Other Identifier: Eli Lilly and Company)
  • 2024-513435-24-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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