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Neuropathic PainPhase 2NCT06568042

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

A Phase 2 study testing LY3848575 in people with Neuropathic Pain and Distal Sensory Polyneuropathy, run by Eli Lilly and Company at 76 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LY3848575
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
558 participants
Where
76 sitesin 7 countries
Study dates
22 Aug 2024to 15 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

76 sites in 7 countries.

76 sites in 7 countries

United States24 sites

  • Asheville Neurology Specialists, PA

    Asheville, North Carolina, 28806

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Alpine Clinical Research Center

    Boulder, Colorado, 80301

  • MD First Research - Chandler

    Chandler, Arizona, 85286

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Cedar Health Research

    Dallas, Texas, 75251

  • Neurology Diagnostics, Inc.

    Dayton, Ohio, 45459

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Biopharma Informatic, LLC

    Houston, Texas, 77043

  • Clinical Trial Network

    Houston, Texas, 77074

  • New Phase Research and Development

    Knoxville, Tennessee, 37909

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

    Largo, Florida, 33777

  • Design Neuroscience Center

    Miami Lakes, Florida, 33016

  • Lucida Clinical Trials

    New Bedford, Massachusetts, 02740

  • Mid Hudson Medical Research

    New Windsor, New York, 12553

  • Conquest Research - Orlando

    Orlando, Florida, 32832

  • HOPE Research Institute

    Phoenix, Arizona, 85032

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi, 39157

  • University of Rochester Medical Center

    Rochester, New York, 14618

  • Charter Research - Lady Lake

    The Villages, Florida, 32162

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265

  • Encore Medical Research - Weston

    Weston, Florida, 33331

  • Center for Clinical Research

    Winston-Salem, North Carolina, 27103

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

Japan18 sites

  • St. Luke's International Hospital

    Chūōku, 104-8560

  • Chugoku Central Hospital

    Fukuyama-shi, 720-0001

  • Mito Medical Center

    Higashiibaraki, 311-3117

  • Rinku General Medical Center

    Izumisano, 598-8577

  • Sagara Hospital

    Kagoshima, 892-0833

  • Kamezawa Clinic

    Kasugai, 486-0817

  • The Cancer Institute Hospital of JFCR

    Kōtō City, 135-8550

  • Kikuchi Naika Clinic

    Maebashi, 370-3573

  • Aizawa Hospital

    Matsumoto, 390-0814

  • Kojunkai Daido Hospital

    Nagoya, 457-8511

  • Nishinomiya Municipal Central Hospital

    Nishinomiya, 663-8014

  • Fujigaki Clinic

    Ōita, 870-0942

  • Medical Corporation Sato Medical Clinic

    Ootaku, 143-0015

  • Minamiosaka Hospital

    Osaka, 559-0012

  • Saga-Ken Medical Centre Koseikan

    Saga, 840-8571

  • Asama General Hospital

    Saku, 385-0022

  • Tokyo Shinagawa Hospital

    Shinagawa-ku, 140-8522

  • Niwa Family Clinic

    Tokyo, 182-0006

Other trials in Japan

Mexico8 sites

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31207

  • Investigación Clínica Cuernavaca, S.C.

    Cuernavaca, 62448

  • Centro de Investigación Clínica y Medicina Traslacional (CIMeT)

    Guadalajara, 44340

  • Health Pharma Querétaro

    Juriquilla, 76230

  • Medical Care and Research SA de CV

    Mérida, 97070

  • Grupo Medico Camino Sc

    Mexico City, 03310

  • Cicmex Centro de Investigación Clínica de México

    Morelia, 58000

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, 68020

Other trials in Mexico

Poland8 sites

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756

  • Centrum Medyczne NEUROMED

    Bydgoszcz, 85-163

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

    Gdansk, 80-546

  • Neuro-Care Sp. z o.o. sp. kom.

    Katowice, 40-749

  • Diamond Clinic

    Krakow, 31-559

  • Santa Familia PTG Lodz

    Lodz, 90-302

  • Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

    Poznan, 61-853

  • MICS Centrum Medyczne Warszawa - Chłodna

    Warsaw, 00-872

Other trials in Poland

Canada7 sites

  • Med Trust Research

    Courtice, L1E 2J5

  • Dawson Clinical Research Inc.

    Guelph, N1H 1B1

  • Premier Clinical Trial Network

    Hamilton, L8L5G4

  • OCT Research ULC

    Kelowna, V1Y 1Z9

  • Genge Partners

    Montreal, H4A 3T2

  • Richmond Clinical Trials

    Richmond, V6V 2L1

  • Bluewater Clinical Research Group Inc.

    Sarnia, N7T 4X3

Other trials in Canada

South Korea6 sites

  • Chosun University Hospital

    Gwangju, 61453

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Konkuk University Medical Center

    Seoul, 05030

  • Samsung Medical Center

    Seoul, 06351

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

    Seoul, 06591

Other trials in South Korea

Germany5 sites

  • FutureMeds GmbH

    Berlin, 10629

  • Studienzentrum Dr. Bischof GmbH

    Böblingen, 71034

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105

  • ZNS Siegen

    Siegen, 57076

  • Studienzentrum Nord-West

    Westerstede, 26655

Other trials in Germany

About this study

Official title: 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.

Being tested
LY3848575, Placebo
Keywords
Peripheral Neuropathy, Diabetic Peripheral Neuropathy, Chemotherapy Induced Peripheral Neuropathy, HIV Induced Peripheral Neuropathy
Medical subject headings
Neuralgia, Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3848575Drug

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT06568042
Study groupRoleWhat they receive
LY3848575 Dose 1ExperimentalLY3848575 low dose administered subcutaneously (SC).
Receives: Drug: LY3848575
LY3848575 Dose 2ExperimentalLY3848575 mid dose administered SC.
Receives: Drug: LY3848575
LY3848575 Dose 3ExperimentalLY3848575 high dose administered SC.
Receives: Drug: LY3848575
PlaceboPlacebo comparatorPlacebo administered SC.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS)

    Measured: Baseline, Week 12

Secondary outcomes (10)

  1. Mean Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS)

    Measured: Baseline, Week 12

  2. Mean Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Custom Form (CF) v1.1

    Measured: Baseline, Week 12

  3. Mean Change from Baseline in Pain Interference with Sleep

    Measured: Baseline, Week 12

  4. Mean Change from Baseline in PROMIS Short Form (SF) Physical Functioning (PF) 10a (PROMIS PF 10a)

    Measured: Baseline, Week 12

  5. Mean Change from Baseline in PROMIS (SF) Sleep Disturbance 8b (PROMIS SD 8b)

    Measured: Baseline, Week 12

  6. Mean Change from Baseline in 36-Item Short Form Health Survey Version 2 (SF-36 v2)

    Measured: Baseline, Week 12

  7. Mean Change from Baseline in Patient's Global Impression (PGI) of Illness Severity as Measured by PGI-Severity

    Measured: Baseline, Week 12

  8. Mean Overall Improvement as Measured by Patient's Global Impression of Change

    Measured: Week 12

  9. Use of Rescue Medication

    Measured: Baseline up to Week 12

  10. Pharmacokinetic (PK): Serum Concentration of LY3848575

    Measured: Baseline up to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2024
  2. Study start22 Aug 2024
  3. Primary completion12 Jan 2026
  4. Study completion15 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
558 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06568042
Sponsor's protocol ID
18825
Other IDs
J4F-MC-CYAB, 2024-513435-24-00
Status last verified
Jul 2026
First submitted
21 Aug 2024
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3848575 in people with Neuropathic Pain and Distal Sensory Polyneuropathy, run by Eli Lilly and Company at 76 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Japan, Mexico, Poland, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06568042.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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