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A new pill takes aim at diabetic nerve pain — will it work?

NCT ID NCT06074562

Symptom relief Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether mazisotine, an oral drug, can reduce the persistent nerve pain that often complicates diabetes. About 400 adults with diabetic peripheral neuropathic pain will receive either mazisotine or a placebo for roughly 24 weeks. Researchers will measure changes in average pain intensity to see if the drug offers meaningful relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental drug called mazisotine (LY3556050)
What this could lead to
If it works, mazisotine could offer a new oral option for the burning, stabbing nerve pain that many people with diabetes experience.
What could go wrong
This is a mid-stage trial, so the drug may not prove more effective than placebo. Side effects are possible, and the results may not apply to everyone with diabetic nerve pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

404 people

The number who actually took part.

Started

Oct 2023

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic peripheral neuropathy

Contacts and locations

Locations

  • Agentura Science Pro

    Olomouc, 779 00, Czechia

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67205, United States

  • Alliance for Multispecialty Research, LLC

    Lexington, Kentucky, 40509, United States

  • Alliance for Multispecialty Research, LLC

    Kansas City, Missouri, 64114, United States

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut, 06517, United States

  • Care Access - Lake Charles

    Lake Charles, Louisiana, 70601, United States

  • Centrum Badań Klinicznych Piotr Napora lekarze sp.p.

    Wroclaw, Lower Silesian Voivodeship, 51-162, Poland

  • Centrum Medyczne Pratia Katowice

    Katowice, Silesian Voivodeship, 40-081, Poland

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

    Lodz, Łódź Voivodeship, 90-338, Poland

  • Clinvest Research LLC

    Springfield, Missouri, 65807, United States

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231, United States

  • DiaVize s.r.o.

    Prague, Praha, Hlavní Mešto, 140 00, Czechia

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

    Prague, Praha 1, 11000, Czechia

  • EDUMED - Broumov

    Broumov, Hradec Králové Region, 550 01, Czechia

  • Eulji University Hospital

    Daejeon, Taejǒn-Kwangyǒkshi, 01830, South Korea

  • FLEDIP - Na dlouhem lanu

    Prague, Praha, Hlavní Mešto, 160 00, Czechia

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731, United States

  • Headlands Research - Scottsdale

    Scottsdale, Arizona, 85260, United States

  • Heishinkai Medical Group ToCROM Clinic

    Shinjuku-ku, Tokyo, 160-0008, Japan

  • Hope Clinical Research, Inc.

    Canoga Park, California, 91303, United States

  • Japanese Red Cross Asahikawa Hospital

    Asahikawa, Hokkaido, 070-8530, Japan

  • Juno Research

    Houston, Texas, 77040, United States

  • Kikuchi Naika Clinic

    Maebashi, Gunma, 370-3573, Japan

  • Konkuk University Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 05030, South Korea

  • Kunisaki Makoto Clinic

    Fukuoka, 819-0168, Japan

  • Kure Medical Center

    Kure, Hiroshima, 737-0023, Japan

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89128, United States

  • Lucas Research - Hickory

    Hickory, North Carolina, 28601, United States

  • Lucas Research, Inc

    Morehead City, North Carolina, 28557, United States

  • MICS Centrum Medyczne Torun

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

  • MICS Centrum Medyczne Warszawa

    Warsaw, Masovian Voivodeship, 00-874, Poland

  • Matsuyama Shimin Hospital

    Matsuyama, Ehime, 790-0067, Japan

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451, United States

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, Osaka, 565-0853, Japan

  • Medical Corporation Sato Medical clinic

    Ootaku, Tokyo, 143-0015, Japan

  • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

    Krakow, Lesser Poland Voivodeship, 31-261, Poland

  • Minamiosaka Hospital

    Osaka, 559-0012, Japan

  • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

    Ruda Śląska, Silesian Voivodeship, 41-709, Poland

  • Neurologická Ambulance - Forbeli

    Prague, Praha 6, 160 00, Czechia

  • New Horizon Research Center

    Miami, Florida, 33165, United States

  • New Phase Research and Development

    Knoxville, Tennessee, 37909, United States

  • North Suffolk Neurology

    Port Jefferson Station, New York, 11776, United States

  • Northern California Research - Sacramento

    Sacramento, California, 95821, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Nowon Eulji Medical Center, Eulji University

    Seoul, Seoul-teukbyeolsi [Seoul], 01830, South Korea

  • Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

    Poznan, Greater Poland Voivodeship, 61-853, Poland

  • Orange Grove Family Practice

    Tucson, Arizona, 85741, United States

  • Plumeria DM Clinic

    Shizuoka, 422-8006, Japan

  • Preferred Research Partners

    Little Rock, Arkansas, 72211, United States

  • Pro Familia Altera

    Katowice, Silesian Voivodeship, 40-648, Poland

  • Rainier Clinical Research Center

    Renton, Washington, 98057, United States

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi, 39157, United States

  • Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow

    Wyszków, Masovian Voivodeship, 07-200, Poland

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

  • Sejong General Hospital

    Sosa-gu, Kyǒnggi-do, 14754, South Korea

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303, United States

  • Suburban Research Associates

    West Chester, Pennsylvania, 19380, United States

  • Sugiura Internal Medicine Clinic

    Sokashi, Saitama, 340-0015, Japan

  • Suncoast Research Group

    Miami, Florida, 33135, United States

  • Suruga Clinic

    Shizuoka, Shizuoka, 424-0855, Japan

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

    Chandler, Arizona, 85225, United States

  • Tristar Clinical Investigations

    Philadelphia, Pennsylvania, 19114, United States

  • UniMed Center

    East Brunswick, New Jersey, 08816, United States

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325, United States

  • Velocity Clinical Research, Medford

    Medford, Oregon, 97504, United States

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088, United States

  • Vestra Clinics

    European Union, Rychnov Nad Kněžnou, 516 01, Czechia

  • Yokohama Minoru Clinic

    Yokohama, Kanagawa, 232-0064, Japan

  • Zdrowie Osteo-Medic

    Biaystok, Podlaskie Voivodeship, 15-351, Poland

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Other studies related to the condition(s) this trial covers.