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

Last updated: January 23, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Pain

Diabetic Neuropathy

Pain (Pediatric)

Treatment

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: 410
Treatment Group(s): 2
Primary Treatment: LY3556050
Phase: 2
Study Start date:
October 05, 2023
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • EDUMED - Broumov

    Broumov, Královéhradecký Kraj 550 01
    Czechia

    Active - Recruiting

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

    Praha, Praha 1 11000
    Czechia

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  • DiaVize s.r.o.

    Praha, Praha 4 140 00
    Czechia

    Site Not Available

  • Neurologická Ambulance - Forbeli

    Praha, Praha 6 160 00
    Czechia

    Active - Recruiting

  • FLEDIP - Na dlouhem lanu

    Prague, Praha, Hlavní Mešto 160 00
    Czechia

    Active - Recruiting

  • FLEDIP s.r.o.

    Prague, Praha, Hlavní Mešto 160 00
    Czechia

    Active - Recruiting

  • DiaVize s.r.o.

    Praha 4, Praha, Hlavní Mešto 140 00
    Czechia

    Active - Recruiting

  • Vestra Clinics

    European Union, Rychnov Nad Kněžnou 516 01
    Czechia

    Active - Recruiting

  • Agentura Science Pro

    Olomouc, 779 00
    Czechia

    Active - Recruiting

  • Matsuyama Shimin Hospital

    Matsuyama, Ehime 790-0067
    Japan

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  • Kikuchi Naika Clinic

    Maebashi, Gunma 370-3573
    Japan

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  • Kure Medical Center

    Kure, Hiroshima 737-0023
    Japan

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  • Japanese Red Cross Asahikawa Hospital

    Asahikawa, Hokkaido 070-8530
    Japan

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  • Yokohama Minoru Clinic

    Yokohama, Kanagawa 232-0064
    Japan

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  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, Osaka 565-0853
    Japan

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  • Sugiura Internal Medicine Clinic

    Soka, Saitama 340-0034
    Japan

    Site Not Available

  • Sugiura Internal Medicine Clinic

    Sokashi, Saitama 340-0015
    Japan

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  • Suruga Clinic

    Shizuoka-city, Shizuoka 424-0855
    Japan

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    Ootaku, Tokyo 143-0015
    Japan

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    Shinjuku-ku, Tokyo 160-0008
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    Ōtake, Tokyo 143-0015
    Japan

    Site Not Available

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    Fukuoka, 819-0168
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    Osaka, 559-0012
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    Shizuoka, 422-8006
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    Jeonju, Jeonrabugdo 54907
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    Jeonju-si, Jeonrabugdo 54907
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    Lodz, Łódzkie 90-338
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    Katowice, Śląskie 40-081
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    Ruda Slaska, Śląskie 41-709
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    Chandler, Arizona 85225
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  • Lucas Research - Hickory

    Hickory, North Carolina 28601
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  • Lucas Research, Inc.

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  • Lucas Research, Inc

    Morehead City, North Carolina 28557
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  • Velocity Clinical Research, Medford

    Medford, Oregon 97504
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  • Tristar Clinical Investigations

    Philadelphia, Pennsylvania 19114
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  • Suburban Research Associates

    West Chester, Pennsylvania 19380
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  • Palmetto Clinical Research

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    Site Not Available

  • New Phase Research and Development

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    West Jordan, Utah 84088
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    Bellevue, Washington 98007
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    Renton, Washington 98057
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