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CompletedPhase 2

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

Key facts

Who runs it
Eli Lilly and Company
Where
Austin, Bellevue, Canoga Park, Chandler, Chicago, City of Saint Peters, East Brunswick, Hamden, Hickory, Houston, Kansas City, Knoxville, Lake Charles, Las Vegas, Lexington, Little Rock, Medford, Miami, Morehead City, Northridge, Philadelphia, Port Jefferson Station, Renton, Ridgeland, Sacramento, Scottsdale, Shavano Park, Springfield, Tucson, Waltham, West Chester, West Jordan, and Wichita, United StatesSee the 34 sitesAlso in 4 other countries, 36 sites
Trial code
Status
Completed
Phase
Phase 2
People taking part
404 people enrolled
Started
5 Oct 2023
Ended
11 Jun 2025
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Mazisotine
  • Placebo
Record updated
30 July 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Have a surgery planned during the study for any reason
  • History of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to DPNP
  • Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision
  • 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 substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)
  • 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
  • Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide

Where in United States

Also in 4 other countries, 36 sites

  • FutureSearch Trials of NeurologyAustin, United States
  • Northwest Clinical Research CenterBellevue, United States
  • Hope Clinical Research, Inc.Canoga Park, United States
  • The Institute for Liver Health II dba Arizona Clinical Trials - MesaChandler, United States
  • Northwestern UniversityChicago, United States
  • StudyMetrix ResearchCity of Saint Peters, United States
  • UniMed CenterEast Brunswick, United States
  • CMR of Greater New Haven, LLCHamden, United States
  • Lucas Research - HickoryHickory, United States
  • Juno ResearchHouston, United States
  • Alliance for Multispecialty Research, LLCKansas City, United States
  • New Phase Research And DevelopmentKnoxville, United States
  • Care Access - Lake CharlesLake Charles, United States
  • Las Vegas Medical ResearchLas Vegas, United States
  • Alliance for Multispecialty Research, LLCLexington, United States
  • Preferred Research PartnersLittle Rock, United States
  • Velocity Clinical Research, MedfordMedford, United States
  • New Horizon Research CenterMiami, United States
  • Suncoast Research GroupMiami, United States
  • Lucas Research, Inc.Morehead City, United States
  • Valley Clinical Trials, Inc.Northridge, United States
  • Tristar Clinical InvestigationsPhiladelphia, United States
  • North Suffolk NeurologyPort Jefferson Station, United States
  • Rainier Clinical Research CenterRenton, United States
  • SKY Integrative Medical Center/SKYCRNGRidgeland, United States
  • Northern California Research - SacramentoSacramento, United States
  • Headlands Research - ScottsdaleScottsdale, United States
  • Consano Clinical Research, LLCShavano Park, United States
  • Clinvest Research, LLCSpringfield, United States
  • Orange Grove Family PracticeTucson, United States
  • MedVadis Research CorporationWaltham, United States
  • Suburban Research AssociatesWest Chester, United States
  • Velocity Clinical Research, Salt Lake CityWest Jordan, United States
  • Alliance for Multispecialty Research LLCWichita, United States

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • PlaceboPlacebo, for comparison

    Participants received a matching dose of placebo administered orally twice daily (BID) over a period of 12 weeks.

  • Mazisotine 50 mgTreatment being tested

    Participants received mazisotine 50 milligrams (mg) administered orally BID over a period of 12 weeks.

    Treatment: Mazisotine

  • Mazisotine 200 mgTreatment being tested

    Participants received mazisotine BID orally, starting at 50 mg and titrated weekly, reaching 100 mg BID by Week 2 and a target maintenance dose of 200 mg BID by Week 3, which was then maintained up to Week 12.

    Treatment: Mazisotine

  • Mazisotine 400 mgTreatment being tested

    Participants received mazisotine BID orally, starting at 50 mg and titrated weekly, reaching 100 mg BID by Week 2, 200 mg BID by Week 3, and 300 mg BID by Week 4, until reaching a target maintenance dose of 400 mg BID by Week 5, which was then maintained up to Week 12.

    Treatment: Mazisotine

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study to Evaluate LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
Record updated
30 July 2026