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NCT06074562

PHASE2

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

404

Start Date

2023-10-05

Completion Date

2025-06-11

Last Updated

2026-07-30

Healthy Volunteers

Conditions

Diabetic Peripheral Neuropathy

Interventions

DRUG

Mazisotine

Administered orally.

DRUG

Placebo

Administered orally.

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)

Locations (70)

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

Chandler, Arizona, United States

Headlands Research - Scottsdale

Scottsdale, Arizona, United States

Orange Grove Family Practice

Tucson, Arizona, United States

Preferred Research Partners

Little Rock, Arkansas, United States

Hope Clinical Research, Inc.

Canoga Park, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

Northern California Research - Sacramento

Sacramento, California, United States

CMR of Greater New Haven, LLC

Hamden, Connecticut, United States

Suncoast Research Group

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Northwestern University

Chicago, Illinois, United States

Alliance for Multispecialty Research, LLC

Wichita, Kansas, United States

Alliance for Multispecialty Research, LLC

Lexington, Kentucky, United States

Care Access - Lake Charles

Lake Charles, Louisiana, United States

MedVadis Research Corporation

Waltham, Massachusetts, United States

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, United States

StudyMetrix Research

City of Saint Peters, Missouri, United States

Alliance for Multispecialty Research, LLC

Kansas City, Missouri, United States

Clinvest Research LLC

Springfield, Missouri, United States

Las Vegas Medical Research

Las Vegas, Nevada, United States

UniMed Center

East Brunswick, New Jersey, United States

North Suffolk Neurology

Port Jefferson Station, New York, United States

Lucas Research - Hickory

Hickory, North Carolina, United States

Lucas Research, Inc

Morehead City, North Carolina, United States

Velocity Clinical Research, Medford

Medford, Oregon, United States

Tristar Clinical Investigations

Philadelphia, Pennsylvania, United States

Suburban Research Associates

West Chester, Pennsylvania, United States

New Phase Research and Development

Knoxville, Tennessee, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

Juno Research

Houston, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Rainier Clinical Research Center

Renton, Washington, United States

EDUMED - Broumov

Broumov, Hradec Králové Region, Czechia

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

Prague, Praha 1, Czechia

Neurologická Ambulance - Forbeli

Prague, Praha 6, Czechia

DiaVize s.r.o.

Prague, Praha, Hlavní Mešto, Czechia

FLEDIP - Na dlouhem lanu

Prague, Praha, Hlavní Mešto, Czechia

Vestra Clinics

European Union, Rychnov Nad Kněžnou, Czechia

Agentura Science Pro

Olomouc, Czechia

Matsuyama Shimin Hospital

Matsuyama, Ehime, Japan

Kikuchi Naika Clinic

Maebashi, Gunma, Japan

Kure Medical Center

Kure, Hiroshima, Japan

Japanese Red Cross Asahikawa Hospital

Asahikawa, Hokkaido, Japan

Yokohama Minoru Clinic

Yokohama, Kanagawa, Japan

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, Japan

Sugiura Internal Medicine Clinic

Sokashi, Saitama, Japan

Suruga Clinic

Shizuoka, Shizuoka, Japan

Medical Corporation Sato Medical clinic

Ootaku, Tokyo, Japan

Heishinkai Medical Group ToCROM Clinic

Shinjuku-ku, Tokyo, Japan

Kunisaki Makoto Clinic

Fukuoka, Japan

Minamiosaka Hospital

Osaka, Japan

Plumeria DM Clinic

Shizuoka, Japan

Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

Poznan, Greater Poland Voivodeship, Poland

MICS Centrum Medyczne Torun

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

Krakow, Lesser Poland Voivodeship, Poland

Centrum Badań Klinicznych Piotr Napora lekarze sp.p.

Wroclaw, Lower Silesian Voivodeship, Poland

MICS Centrum Medyczne Warszawa

Warsaw, Masovian Voivodeship, Poland

Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow

Wyszków, Masovian Voivodeship, Poland

Zdrowie Osteo-Medic

Biaystok, Podlaskie Voivodeship, Poland

Centrum Medyczne Pratia Katowice

Katowice, Silesian Voivodeship, Poland

Pro Familia Altera

Katowice, Silesian Voivodeship, Poland

NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

Ruda Śląska, Silesian Voivodeship, Poland

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

Lodz, Łódź Voivodeship, Poland

Sejong General Hospital

Sosa-gu, Kyǒnggi-do, South Korea

Nowon Eulji Medical Center, Eulji University

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Konkuk University Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Eulji University Hospital

Daejeon, Taejǒn-Kwangyǒkshi, South Korea

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (70)