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

July 8, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
558

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

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 Investigacion Clinica 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 12, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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