Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J2P-MC-LXBD | Other Identifier | Eli Lilly and Company | |
| 2023-506127-29-00 | Other Identifier | EU Trial Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3556050 Dose 1 | Experimental | Participants will receive LY3556050 orally. |
|
| LY3556050 Dose 2 | Experimental | Participants will receive LY3556050 orally. |
|
| LY3556050 Dose 3 | Experimental | Participants will receive LY3556050 orally. |
|
| Placebo | Placebo Comparator | Participants will receive placebo orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3556050 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline for Average Pain Intensity Numeric Rating Scale (API-NRS) | Baseline, Week 12 |
| Measure | Description | 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 |
Not provided
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
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Institute for Liver Health II dba Arizona Clinical Trials - Mesa | Chandler | Arizona | 85225 | United States | ||
Not provided
| Label | URL |
|---|---|
| A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain | View source |
Not provided
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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Administered orally. |
|
| 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 |
| Headlands Research - Scottsdale |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Orange Grove Family Practice | Tucson | Arizona | 85741 | United States |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | United States |
| Hope Clinical Research, Inc. | Canoga Park | California | 91303 | United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| Northern California Research - Sacramento | Sacramento | California | 95821 | United States |
| CMR of Greater New Haven, LLC | Hamden | Connecticut | 06517 | United States |
| Suncoast Research Group | Miami | Florida | 33135 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Alliance for Multispecialty Research, LLC | Wichita | Kansas | 67205 | United States |
| Alliance for Multispecialty Research, LLC | Lexington | Kentucky | 40509 | United States |
| Care Access - Lake Charles | Lake Charles | Louisiana | 70601 | United States |
| MedVadis Research Corporation | Waltham | Massachusetts | 02451 | United States |
| SKY Integrative Medical Center/SKYCRNG | Ridgeland | Mississippi | 39157 | United States |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | United States |
| Alliance for Multispecialty Research, LLC | Kansas City | Missouri | 64114 | United States |
| Clinvest Research LLC | Springfield | Missouri | 65807 | United States |
| Las Vegas Medical Research | Las Vegas | Nevada | 89128 | United States |
| UniMed Center | East Brunswick | New Jersey | 08816 | United States |
| North Suffolk Neurology | Port Jefferson Station | New York | 11776 | United States |
| Lucas Research - Hickory | Hickory | North Carolina | 28601 | United States |
| Lucas Research, Inc | Morehead City | North Carolina | 28557 | United States |
| Velocity Clinical Research, Medford | Medford | Oregon | 97504 | United States |
| Tristar Clinical Investigations | Philadelphia | Pennsylvania | 19114 | United States |
| Suburban Research Associates | West Chester | Pennsylvania | 19380 | United States |
| New Phase Research and Development | Knoxville | Tennessee | 37909 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | United States |
| Juno Research | Houston | Texas | 77040 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| Velocity Clinical Research, Salt Lake City | West Jordan | Utah | 84088 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| EDUMED - Broumov | Broumov | Hradec Králové Region | 550 01 | Czechia |
| Diabet2 s.r.o., diabetologicka a interni ambulance | Prague | Praha 1 | 11000 | Czechia |
| Neurologická Ambulance - Forbeli | Prague | Praha 6 | 160 00 | Czechia |
| DiaVize s.r.o. | Prague | Praha, Hlavní Mešto | 140 00 | Czechia |
| FLEDIP - Na dlouhem lanu | Prague | Praha, Hlavní Mešto | 160 00 | Czechia |
| Vestra Clinics | European Union | Rychnov Nad Kněžnou | 516 01 | Czechia |
| Agentura Science Pro | Olomouc | 779 00 | Czechia |
| Matsuyama Shimin Hospital | Matsuyama | Ehime | 790-0067 | Japan |
| Kikuchi Naika Clinic | Maebashi | Gunma | 370-3573 | Japan |
| Kure Medical Center | Kure | Hiroshima | 737-0023 | Japan |
| Japanese Red Cross Asahikawa Hospital | Asahikawa | Hokkaido | 070-8530 | Japan |
| Yokohama Minoru Clinic | Yokohama | Kanagawa | 232-0064 | Japan |
| Medical Corporation Heishinkai OCROM Clinic | Suita-shi | Osaka | 565-0853 | Japan |
| Sugiura Internal Medicine Clinic | Sokashi | Saitama | 340-0015 | Japan |
| Suruga Clinic | Shizuoka | Shizuoka | 424-0855 | Japan |
| Medical Corporation Sato Medical clinic | Ootaku | Tokyo | 143-0015 | Japan |
| Heishinkai Medical Group ToCROM Clinic | Shinjuku-ku | Tokyo | 160-0008 | Japan |
| Kunisaki Makoto Clinic | Fukuoka | 819-0168 | Japan |
| Minamiosaka Hospital | Osaka | 559-0012 | Japan |
| Plumeria DM Clinic | Shizuoka | 422-8006 | Japan |
| Nzoz Neuro-Kard Ilkowski i Partnerzy SPL | Poznan | Greater Poland Voivodeship | 61-853 | Poland |
| MICS Centrum Medyczne Torun | Torun | Kuyavian-Pomeranian Voivodeship | 87-100 | Poland |
| Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET | Krakow | Lesser Poland Voivodeship | 31-261 | Poland |
| Centrum Badań Klinicznych Piotr Napora lekarze sp.p. | Wroclaw | Lower Silesian Voivodeship | 51-162 | Poland |
| MICS Centrum Medyczne Warszawa | Warsaw | Masovian Voivodeship | 00-874 | Poland |
| Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow | Wyszków | Masovian Voivodeship | 07-200 | Poland |
| Zdrowie Osteo-Medic | Biaystok | Podlaskie Voivodeship | 15-351 | Poland |
| Centrum Medyczne Pratia Katowice | Katowice | Silesian Voivodeship | 40-081 | Poland |
| Pro Familia Altera | Katowice | Silesian Voivodeship | 40-648 | Poland |
| NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki | Ruda Śląska | Silesian Voivodeship | 41-709 | Poland |
| Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | Łódź Voivodeship | 90-338 | Poland |
| Sejong General Hospital | Sosa-gu | Kyǒnggi-do | 14754 | South Korea |
| Nowon Eulji Medical Center, Eulji University | Seoul | Seoul-teukbyeolsi [Seoul] | 01830 | South Korea |
| Konkuk University Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | 05030 | South Korea |
| Samsung Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | 06351 | South Korea |
| Eulji University Hospital | Daejeon | Taejǒn-Kwangyǒkshi | 01830 | South Korea |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 10, 2026 | Jul 6, 2026 | 16 | ||
| Jul 6, 2026 |