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

A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study to Evaluate LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Drug: Placebo; Drug: LY3556050

• Study Type: Interventional
• Enrollment (Actual): 405
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Olomouc, Czechia, 779 00
    • Agentura Science Pro
  • Královéhradecký Kraj
    • Broumov, Královéhradecký Kraj, Czechia, 550 01
      • EDUMED - Broumov
  • Praha 1
    • Praha, Praha 1, Czechia, 11000
      • Diabet2 s.r.o., diabetologicka a interni ambulance
  • Praha 6
    • Praha, Praha 6, Czechia, 160 00
      • Neurologická Ambulance - Forbeli
  • Praha, Hlavní Mešto
    • Prague, Praha, Hlavní Mešto, Czechia, 160 00
      • FLEDIP - Na dlouhem lanu
    • Praha 4, Praha, Hlavní Mešto, Czechia, 140 00
      • DiaVize s.r.o.
  • Rychnov Nad Kněžnou
    • European Union, Rychnov Nad Kněžnou, Czechia, 516 01
      • Vestra Clinics
• Japan
  • Fukuoka, Japan, 819-0168
    • Kunisaki Makoto Clinic
  • Osaka, Japan, 559-0012
    • Minamiosaka Hospital
  • Shizuoka, Japan, 422-8006
    • Plumeria DM Clinic
  • Ehime
    • Matsuyama, Ehime, Japan, 790-0067
      • Matsuyama Shimin Hospital
  • Gunma
    • Maebashi, Gunma, Japan, 370-3573
      • Kikuchi Naika Clinic
  • Hiroshima
    • Kure, Hiroshima, Japan, 737-0023
      • Kure Medical Center
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 070-8530
      • Japanese Red Cross Asahikawa Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 232-0064
      • Yokohama Minoru Clinic
  • Osaka
    • Suita-shi, Osaka, Japan, 565-0853
      • Medical Corporation Heishinkai OCROM Clinic
  • Saitama
    • Sokashi, Saitama, Japan, 340-0015
      • Sugiura Internal Medicine Clinic
  • Shizuoka
    • Shizuoka-city, Shizuoka, Japan, 424-0855
      • Suruga Clinic
  • Tokyo
    • Ootaku, Tokyo, Japan, 143-0015
      • Medical Corporation Sato Medical clinic
    • Shinjuku-ku, Tokyo, Japan, 160-0008
      • Heishinkai Medical Group ToCROM Clinic
• Korea, Republic of
  • Kyǒnggi-do
    • Sosa-gu, Kyǒnggi-do, Korea, Republic of, 14754
      • Sejong General Hospital
  • Seoul-teukbyeolsi [Seoul]
    • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
      • Samsung Medical Center
    • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05030
      • Konkuk University Medical Center
    • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 01830
      • Nowon Eulji Medical Center, Eulji University
  • Taejǒn-Kwangyǒkshi
    • Daejeon, Taejǒn-Kwangyǒkshi, Korea, Republic of, 01830
      • Eulji University Hospital
• Poland
  • Dolnośląskie
    • Wroclaw, Dolnośląskie, Poland, 51-162
      • Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
  • Kujawsko-pomorskie
    • Torun, Kujawsko-pomorskie, Poland, 87-100
      • MICS Centrum Medyczne Torun
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 00-874
      • MICS Centrum Medyczne Warszawa
    • Wyszkow, Mazowieckie, Poland, 07-200
      • Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow
  • Małopolskie
    • Krakow, Małopolskie, Poland, 31-261
      • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
  • Podlaskie
    • Biaystok, Podlaskie, Poland, 15-351
      • Zdrowie Osteo-Medic
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 61-853
      • Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
  • Łódzkie
    • Lodz, Łódzkie, Poland, 90-338
      • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
  • Śląskie
    • Katowice, Śląskie, Poland, 40-081
      • Centrum Medyczne Pratia Katowice
    • Katowice, Śląskie, Poland, 40-648
      • Pro Familia Altera
    • Ruda Slaska, Śląskie, Poland, 41-709
      • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
• United States
  • Arizona
    • Chandler, Arizona, United States, 85225
      • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
    • Scottsdale, Arizona, United States, 85260
      • Headlands Research - Scottsdale
    • Tucson, Arizona, United States, 85741
      • Orange Grove Family Practice
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners
  • California
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research, Inc.
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • Sacramento, California, United States, 95821
      • Northern California Research - Sacramento
  • Connecticut
    • Hamden, Connecticut, United States, 06517
      • CMR of Greater New Haven, LLC
  • Florida
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • Miami, Florida, United States, 33135
      • Suncoast Research Group
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Kansas
    • Wichita, Kansas, United States, 67205
      • Alliance for Multispecialty Research, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Alliance for Multispecialty Research, LLC
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Care Access - Lake Charles
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • MedVadis Research Corporation
  • Mississippi
    • Ridgeland, Mississippi, United States, 39157
      • SKY Integrative Medical Center/SKYCRNG
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Alliance for Multispecialty Research, LLC
    • Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research
    • Springfield, Missouri, United States, 65807
      • Clinvest Research LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Las Vegas Medical Research
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • UniMed Center
  • New York
    • Port Jefferson Station, New York, United States, 11776
      • North Suffolk Neurology
  • North Carolina
    • Hickory, North Carolina, United States, 28601
      • Lucas Research - Hickory
    • Morehead City, North Carolina, United States, 28557
      • Lucas Research, Inc
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research, Medford
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Tristar Clinical Investigations
    • West Chester, Pennsylvania, United States, 19380
      • Suburban Research Associates
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • New Phase Research and Development
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology
    • Houston, Texas, United States, 77040
      • Juno Research
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, LLC
  • Utah
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research, Salt Lake City
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 90 days prior to day 1 with a hemoglobin A1c (HbA1c) ≤10 for T1D and HbA1c ≤11 for participants with T2D at time of screening.
• Have a history of daily peripheral neuropathic pain for at least 12 weeks based on participant 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 lower extremities for ≥6 months and diagnosed by a score of Part B ≥3 on Michigan Neuropathy Screening Instrument
• Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.

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

  • 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 Criteria:

• History of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to DPNP.
• Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques.
• Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
• Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
• Have in the judgement of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study 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 of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive placebo orally.	Drug: Placebo; Administered orally.
Experimental: LY3556050 Dose 1; Participants will receive LY3556050 orally.	Drug: LY3556050; Administered orally.
Experimental: LY3556050 Dose 2; Participants will receive LY3556050 orally.	Drug: LY3556050; Administered orally.
Experimental: LY3556050 Dose 3; Participants will receive LY3556050 orally.	Drug: LY3556050; Administered orally.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean Change from Baseline for Worst Pain Intensity Numeric Rating Scale (WPI-NRS)	Baseline, Week 12
Mean Change from Baseline for Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF)8a	Baseline, Week 12
Mean Change from Baseline for Pain Interference with Sleep	Baseline, Week 12
Mean Change from Baseline for PROMIS Physical Functioning Short Form (SF)10a	Baseline, Week 12
Mean Change from Baseline for PROMIS Sleep Disturbance (SD)8b	Baseline, Week 12
Mean Change from Baseline for Patient's Global Impression of Illness (PGI) Severity as Measured by PGI-Severity	Baseline, Week 12
Mean Change from Baseline for Patient's Global Impression of Illness Status as Measured by PGI-Status	Baseline, Week 12
Mean Change from Baseline for Patient's Global Impression of Change as Measured by PGI-Change	Baseline, Week 12
Mean Change from Baseline for Neuropathy Total Symptom Score-6 (NTSS-6)	Baseline, Week 12
Summary of Frequency, Timing and Amount of Rescue Medication Used During the Treatment Period	Baseline to Week 12
Pharmacokinetics (PK): Plasma Concentration of LY3556050	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Actual): June 11, 2025
• Study Completion (Actual): June 11, 2025

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Neuralgia; Peripheral Nervous System Diseases
• Other Study ID Numbers: 18509; J2P-MC-LXBD (Other Identifier: Eli Lilly and Company); 2023-506127-29-00 (Other Identifier: EU Trial Number)

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