A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
NCT ID: NCT06074562
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
405 participants
INTERVENTIONAL
2023-10-05
2025-06-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain
NCT04707157
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
NCT07285018
A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05).
NCT05620576
Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain
NCT05177094
Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy
NCT06568042
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LY3556050 Dose 1
Participants will receive LY3556050 orally.
LY3556050
Administered orally.
LY3556050 Dose 2
Participants will receive LY3556050 orally.
LY3556050
Administered orally.
LY3556050 Dose 3
Participants will receive LY3556050 orally.
LY3556050
Administered orally.
Placebo
Participants will receive placebo orally.
Placebo
Administered orally.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LY3556050
Administered orally.
Placebo
Administered orally.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, Královéhradecký kraj, 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
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
J2P-MC-LXBD
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506127-29-00
Identifier Type: OTHER
Identifier Source: secondary_id
18509
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.