A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain

Last updated: July 6, 2026
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

2

Condition

Pain (Pediatric)

Diabetes Mellitus Types I And Ii

Pain

Treatment

Mazisotine

LY3556050

Placebo

Clinical Study ID

NCT06074562
18509
2023-506127-29-00
J2P-MC-LXBD
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to determine the safety and efficacy of LY3556050 versus placebo in participants with diabetic peripheral neuropathic pain (DPNP). The study will lasts approximately 24 weeks, across 3 study periods.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a history and current diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) diagnosed for at least 6 months prior to screening.

  • Have a stable glycemic control on stable diabetes treatment regimen for at least 90days prior to day 1 with a hemoglobin A1c (HbA1c) ≤10 for T1D and HbA1c ≤11 forparticipants with T2D at time of screening.

  • Have a history of daily peripheral neuropathic pain for at least 12 weeks based onparticipant report or medical history.

  • Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.

  • Have presence of diabetic peripheral neuropathy of symmetrical nature and in lowerextremities for ≥6 months and diagnosed by a score of Part B ≥3 on MichiganNeuropathy Screening Instrument

  • Are willing to maintain a consistent regimen of any ongoing nonpharmacologicpain-relieving therapies (for example, physical therapy) and will not start any newnonpharmacologic pain-relieving therapies during study participation.

  • Are willing to discontinue all medications taken for chronic pain conditions, exceptallowed concomitant pain medication permitted per protocol, for the duration of thestudy

  • Have a body mass index ≤45 kilogram/square meter (kg/m²) (inclusive).

  • Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion

Exclusion Criteria:

  • History of other potentially causative and/or confounding sources of pain that mayimpair self-assessment of pain due to DPNP.

  • Have had a procedure within the past 6 months intended to produce permanent sensoryloss in the target area of interest (for example, ablation techniques.

  • Have had cancer within 2 years of baseline, except for cutaneous basal cell orsquamous cell carcinoma resolved by excision.

  • Are, in the judgment of the investigator, actively suicidal and therefore deemed tobe at significant risk for suicide.

  • Have in the judgement of the investigator, an acute, serious, or unstable medicalcondition or a history or presence of any other medical illness that would precludestudy participation.

  • Have a positive HIV test result at screening.

  • Have a surgery planned during the study for any reason.

  • Have a substance use disorder as defined by the Diagnostic and Statistical Manual ofMental Disorders (5th edition; DSM-5; American Psychiatric Association)

Study Design

Total Participants: 404
Treatment Group(s): 3
Primary Treatment: Mazisotine
Phase: 2
Study Start date:
October 05, 2023
Estimated Completion Date:
June 11, 2025

Connect with a study center

  • EDUMED - Broumov

    Broumov, Hradec Králové Region 550 01
    Czechia

    Site Not Available

  • Diabet2 s.r.o., diabetologicka a interni ambulance

    Prague, Praha 1 11000
    Czechia

    Site Not Available

  • Neurologická Ambulance - Forbeli

    Prague, Praha 6 160 00
    Czechia

    Site Not Available

  • DiaVize s.r.o.

    Prague, Praha, Hlavní Mešto 140 00
    Czechia

    Site Not Available

  • FLEDIP - Na dlouhem lanu

    Prague, Praha, Hlavní Mešto 160 00
    Czechia

    Site Not Available

  • Vestra Clinics

    European Union, Rychnov Nad Kněžnou 516 01
    Czechia

    Site Not Available

  • Agentura Science Pro

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Matsuyama Shimin Hospital

    Matsuyama, Ehime 790-0067
    Japan

    Site Not Available

  • Kikuchi Naika Clinic

    Maebashi, Gunma 370-3573
    Japan

    Site Not Available

  • Kure Medical Center

    Kure, Hiroshima 737-0023
    Japan

    Site Not Available

  • Japanese Red Cross Asahikawa Hospital

    Asahikawa, Hokkaido 070-8530
    Japan

    Site Not Available

  • Yokohama Minoru Clinic

    Yokohama, Kanagawa 232-0064
    Japan

    Site Not Available

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, Osaka 565-0853
    Japan

    Site Not Available

  • Sugiura Internal Medicine Clinic

    Sokashi, Saitama 340-0015
    Japan

    Site Not Available

  • Suruga Clinic

    Shizuoka, Shizuoka 424-0855
    Japan

    Site Not Available

  • Medical Corporation Sato Medical clinic

    Ootaku, Tokyo 143-0015
    Japan

    Site Not Available

  • Heishinkai Medical Group ToCROM Clinic

    Shinjuku-ku, Tokyo 160-0008
    Japan

    Site Not Available

  • Kunisaki Makoto Clinic

    Fukuoka, 819-0168
    Japan

    Site Not Available

  • Minamiosaka Hospital

    Osaka, 559-0012
    Japan

    Site Not Available

  • Plumeria DM Clinic

    Shizuoka, 422-8006
    Japan

    Site Not Available

  • Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

    Poznan, Greater Poland Voivodeship 61-853
    Poland

    Site Not Available

  • MICS Centrum Medyczne Torun

    Torun, Kuyavian-Pomeranian Voivodeship 87-100
    Poland

    Site Not Available

  • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

    Krakow, Lesser Poland Voivodeship 31-261
    Poland

    Site Not Available

  • Centrum Badań Klinicznych Piotr Napora lekarze sp.p.

    Wroclaw, Lower Silesian Voivodeship 51-162
    Poland

    Site Not Available

  • MICS Centrum Medyczne Warszawa

    Warsaw, Masovian Voivodeship 00-874
    Poland

    Site Not Available

  • Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow

    Wyszków, Masovian Voivodeship 07-200
    Poland

    Site Not Available

  • Zdrowie Osteo-Medic

    Biaystok, Podlaskie Voivodeship 15-351
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Katowice

    Katowice, Silesian Voivodeship 40-081
    Poland

    Site Not Available

  • Pro Familia Altera

    Katowice, Silesian Voivodeship 40-648
    Poland

    Site Not Available

  • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

    Ruda Śląska, Silesian Voivodeship 41-709
    Poland

    Site Not Available

  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

    Lodz, Łódź Voivodeship 90-338
    Poland

    Site Not Available

  • Sejong General Hospital

    Sosa-gu, Kyǒnggi-do 14754
    South Korea

    Site Not Available

  • Konkuk University Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul] 05030
    South Korea

    Site Not Available

  • Nowon Eulji Medical Center, Eulji University

    Seoul, Seoul-teukbyeolsi [Seoul] 01830
    South Korea

    Site Not Available

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul] 06351
    South Korea

    Site Not Available

  • Eulji University Hospital

    Daejeon, Taejǒn-Kwangyǒkshi 01830
    South Korea

    Site Not Available

  • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa

    Chandler, Arizona 85225
    United States

    Site Not Available

  • Headlands Research - Scottsdale

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Orange Grove Family Practice

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Preferred Research Partners

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Hope Clinical Research, Inc.

    Canoga Park, California 91303
    United States

    Site Not Available

  • Valley Clinical Trials, Inc.

    Northridge, California 91325
    United States

    Site Not Available

  • Northern California Research - Sacramento

    Sacramento, California 95821
    United States

    Site Not Available

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut 06517
    United States

    Site Not Available

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Site Not Available

  • Suncoast Research Group

    Miami, Florida 33135
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas 67205
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Care Access - Lake Charles

    Lake Charles, Louisiana 70601
    United States

    Site Not Available

  • MedVadis Research Corporation

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • StudyMetrix Research

    City of Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Clinvest Research LLC

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Las Vegas Medical Research

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • UniMed Center

    East Brunswick, New Jersey 08816
    United States

    Site Not Available

  • North Suffolk Neurology

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • Lucas Research - Hickory

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • Lucas Research, Inc

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Velocity Clinical Research, Medford

    Medford, Oregon 97504
    United States

    Site Not Available

  • Tristar Clinical Investigations

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Suburban Research Associates

    West Chester, Pennsylvania 19380
    United States

    Site Not Available

  • New Phase Research and Development

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • FutureSearch Trials of Neurology

    Austin, Texas 78731
    United States

    Site Not Available

  • Juno Research

    Houston, Texas 77040
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Site Not Available

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