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Un estudio de LY3556050 en participantes adultos con dolor neuropático periférico diabético

6 de julio de 2026 actualizado por: Eli Lilly and Company

Un estudio de fase 2, aleatorizado, doble ciego, controlado con placebo y de rango de dosis para evaluar LY3556050 en participantes adultos con dolor neuropático periférico diabético

El objetivo principal de este estudio es determinar la seguridad y eficacia de LY3556050 versus placebo en participantes con dolor neuropático periférico diabético (DPNP). El estudio tendrá una duración aproximada de 24 semanas, divididas en 3 períodos de estudio.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

404

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Chequia
      • Olomouc, Chequia, 779 00
        • Agentura Science Pro
    • Hradec Králové Region
      • Broumov, Hradec Králové Region, Chequia, 550 01
        • EDUMED - Broumov
    • Praha 1
      • Prague, Praha 1, Chequia, 11000
        • Diabet2 s.r.o., diabetologicka a interni ambulance
    • Praha 6
      • Prague, Praha 6, Chequia, 160 00
        • Neurologická Ambulance - Forbeli
    • Praha, Hlavní Mešto
      • Prague, Praha, Hlavní Mešto, Chequia, 160 00
        • FLEDIP - Na dlouhem lanu
      • Prague, Praha, Hlavní Mešto, Chequia, 140 00
        • DiaVize s.r.o.
    • Rychnov Nad Kněžnou
      • European Union, Rychnov Nad Kněžnou, Chequia, 516 01
        • Vestra Clinics
  • Corea del Sur
    • Kyǒnggi-do
      • Sosa-gu, Kyǒnggi-do, Corea del Sur, 14754
        • Sejong General Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sur, 06351
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sur, 01830
        • Nowon Eulji Medical Center, Eulji University
      • Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sur, 05030
        • Konkuk University Medical Center
    • Taejǒn-Kwangyǒkshi
      • Daejeon, Taejǒn-Kwangyǒkshi, Corea del Sur, 01830
        • Eulji University Hospital
  • Estados Unidos
    • Arizona
      • Chandler, Arizona, Estados Unidos, 85225
        • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
      • Scottsdale, Arizona, Estados Unidos, 85260
        • Headlands Research - Scottsdale
      • Tucson, Arizona, Estados Unidos, 85741
        • Orange Grove Family Practice
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72211
        • Preferred Research Partners
    • California
      • Canoga Park, California, Estados Unidos, 91303
        • Hope Clinical Research, Inc.
      • Northridge, California, Estados Unidos, 91325
        • Valley Clinical Trials, Inc.
      • Sacramento, California, Estados Unidos, 95821
        • Northern California Research - Sacramento
    • Connecticut
      • Hamden, Connecticut, Estados Unidos, 06517
        • CMR of Greater New Haven, LLC
    • Florida
      • Miami, Florida, Estados Unidos, 33165
        • New Horizon Research Center
      • Miami, Florida, Estados Unidos, 33135
        • Suncoast Research Group
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Northwestern University
    • Kansas
      • Wichita, Kansas, Estados Unidos, 67205
        • Alliance for Multispecialty Research, LLC
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40509
        • Alliance for Multispecialty Research, LLC
    • Louisiana
      • Lake Charles, Louisiana, Estados Unidos, 70601
        • Care Access - Lake Charles
    • Massachusetts
      • Waltham, Massachusetts, Estados Unidos, 02451
        • MedVadis Research Corporation
    • Mississippi
      • Ridgeland, Mississippi, Estados Unidos, 39157
        • SKY Integrative Medical Center/SKYCRNG
    • Missouri
      • City of Saint Peters, Missouri, Estados Unidos, 63303
        • StudyMetrix Research
      • Kansas City, Missouri, Estados Unidos, 64114
        • Alliance for Multispecialty Research, LLC
      • Springfield, Missouri, Estados Unidos, 65807
        • Clinvest Research LLC
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89128
        • Las Vegas Medical Research
    • New Jersey
      • East Brunswick, New Jersey, Estados Unidos, 08816
        • UniMed Center
    • New York
      • Port Jefferson Station, New York, Estados Unidos, 11776
        • North Suffolk Neurology
    • North Carolina
      • Hickory, North Carolina, Estados Unidos, 28601
        • Lucas Research - Hickory
      • Morehead City, North Carolina, Estados Unidos, 28557
        • Lucas Research, Inc
    • Oregon
      • Medford, Oregon, Estados Unidos, 97504
        • Velocity Clinical Research, Medford
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19114
        • Tristar Clinical Investigations
      • West Chester, Pennsylvania, Estados Unidos, 19380
        • Suburban Research Associates
    • Tennessee
      • Knoxville, Tennessee, Estados Unidos, 37909
        • New Phase Research and Development
    • Texas
      • Austin, Texas, Estados Unidos, 78731
        • FutureSearch Trials of Neurology
      • Houston, Texas, Estados Unidos, 77040
        • Juno Research
      • Shavano Park, Texas, Estados Unidos, 78231
        • Consano Clinical Research, LLC
    • Utah
      • West Jordan, Utah, Estados Unidos, 84088
        • Velocity Clinical Research, Salt Lake City
    • Washington
      • Bellevue, Washington, Estados Unidos, 98007
        • Northwest Clinical Research Center
      • Renton, Washington, Estados Unidos, 98057
        • Rainier Clinical Research Center
  • Japón
      • Fukuoka, Japón, 819-0168
        • Kunisaki Makoto Clinic
      • Osaka, Japón, 559-0012
        • Minamiosaka Hospital
      • Shizuoka, Japón, 422-8006
        • Plumeria DM Clinic
    • Ehime
      • Matsuyama, Ehime, Japón, 790-0067
        • Matsuyama Shimin Hospital
    • Gunma
      • Maebashi, Gunma, Japón, 370-3573
        • Kikuchi Naika Clinic
    • Hiroshima
      • Kure, Hiroshima, Japón, 737-0023
        • Kure Medical Center
    • Hokkaido
      • Asahikawa, Hokkaido, Japón, 070-8530
        • Japanese Red Cross Asahikawa Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japón, 232-0064
        • Yokohama Minoru Clinic
    • Osaka
      • Suita-shi, Osaka, Japón, 565-0853
        • Medical Corporation Heishinkai OCROM Clinic
    • Saitama
      • Sokashi, Saitama, Japón, 340-0015
        • Sugiura Internal Medicine Clinic
    • Shizuoka
      • Shizuoka, Shizuoka, Japón, 424-0855
        • Suruga Clinic
    • Tokyo
      • Ootaku, Tokyo, Japón, 143-0015
        • Medical Corporation Sato Medical clinic
      • Shinjuku-ku, Tokyo, Japón, 160-0008
        • Heishinkai Medical Group ToCROM Clinic
  • Polonia
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polonia, 61-853
        • Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
    • Kuyavian-Pomeranian Voivodeship
      • Torun, Kuyavian-Pomeranian Voivodeship, Polonia, 87-100
        • MICS Centrum Medyczne Toruń
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polonia, 31-261
        • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polonia, 51-162
        • Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polonia, 00-874
        • MICS Centrum Medyczne Warszawa
      • Wyszków, Masovian Voivodeship, Polonia, 07-200
        • Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow
    • Podlaskie Voivodeship
      • Biaystok, Podlaskie Voivodeship, Polonia, 15-351
        • Zdrowie Osteo-Medic
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Polonia, 40-081
        • Centrum Medyczne Pratia Katowice
      • Katowice, Silesian Voivodeship, Polonia, 40-648
        • Pro Familia Altera
      • Ruda Śląska, Silesian Voivodeship, Polonia, 41-709
        • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polonia, 90-338
        • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Tener antecedentes y diagnóstico actual de diabetes tipo 1 (DT1) o diabetes tipo 2 (DT2) diagnosticados durante al menos 6 meses antes de la evaluación.
  • Tener un control glucémico estable con un régimen de tratamiento estable para la diabetes durante al menos 90 días antes del día 1 con una hemoglobina A1c (HbA1c) ≤10 en el momento de la evaluación.
  • Tener antecedentes de dolor neuropático periférico diario durante al menos 12 semanas según el informe del participante o el historial médico.
  • Tener un valor de dolor en la escala visual analógica (EVA) ≥40 y <95 durante la selección.
  • Tener presencia de neuropatía periférica diabética de naturaleza simétrica y en las extremidades inferiores durante ≥6 meses y diagnosticada con una puntuación de la Parte B ≥3 en el Michigan Neuroopathy Screening Instrument.
  • Están dispuestos a mantener un régimen constante de cualquier terapia no farmacológica para aliviar el dolor en curso (por ejemplo, fisioterapia) y no iniciarán ninguna nueva terapia no farmacológica para aliviar el dolor durante la participación en el estudio.

  • Están dispuestos a suspender todos los medicamentos tomados para afecciones de dolor crónico, excepto los analgésicos concomitantes permitidos por protocolo, durante la duración del estudio.

    • Tener un índice de masa corporal ≤45 kilogramo/metro cuadrado (kg/m²) (inclusive).
    • ¿Son los hombres o las mujeres capaces de cumplir con los requisitos reproductivos y anticonceptivos?

Criterio de exclusión:

  • Antecedentes de otras fuentes de dolor potencialmente causantes y/o confusas que puedan afectar la autoevaluación del dolor debido al DPNP.
  • Haber tenido un procedimiento en los últimos 6 meses destinado a producir pérdida sensorial permanente en el área de interés objetivo (por ejemplo, técnicas de ablación).
  • Haber tenido cáncer dentro de los 2 años posteriores al inicio, excepto carcinoma cutáneo de células basales o de células escamosas resuelto mediante escisión.
  • Son, a juicio del investigador, activamente suicidas y, por lo tanto, se considera que tienen un riesgo significativo de suicidio.
  • Tener, a juicio del investigador, una condición médica aguda, grave o inestable o antecedentes o presencia de cualquier otra enfermedad médica que impediría la participación en el estudio.
  • Tener un resultado positivo en la prueba de VIH en el cribado.
  • Tener planificada una cirugía durante el estudio por cualquier motivo.
  • Tiene un trastorno por uso de sustancias según lo definido por el Manual diagnóstico y estadístico de trastornos mentales (quinta edición; DSM-5; Asociación Estadounidense de Psiquiatría)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Participants received a matching dose of placebo administered orally twice daily (BID) over a period of 12 weeks.
Droga: Placebo
Administrado por vía oral.
Experimental: Mazisotine 50 mg
Participants received mazisotine 50 milligrams (mg) administered orally BID over a period of 12 weeks.
Droga: Mazisotine
Administered orally.
Otros nombres:
  • LY3556050
Experimental: Mazisotine 200 mg
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.
Droga: Mazisotine
Administered orally.
Otros nombres:
  • LY3556050
Experimental: Mazisotine 400 mg
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.
Droga: Mazisotine
Administered orally.
Otros nombres:
  • LY3556050

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Change From Baseline in Average Pain Intensity (API) as Measured by Weekly Average of Numeric Rating Scale (NRS) - Bayesian Model Averaging (BMA) Dose-response Model
Periodo de tiempo: Baseline, Week 12
  • The NRS was a single-item numeric scale used to describe pain severity. Participants were asked to rate their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine; a higher score indicates worse outcome (greater pain severity).
  • The mixed-model repeated measures (MMRM) model included the fixed, centered, categorical effects of region, baseline NRS average pain score, as well as concurrent use of allowed concomitant medications (yes vs. no based on interactive web response system [IWRS]), and visit. The adjusted dose response value from the MMRM was used for fitting a Bayesian model averaging (BMA) dose-response model.
  • Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented were posterior mean with 95% credible interval.
Baseline, Week 12
Mean Change From Baseline in Average Pain Intensity (API) as Measured by Weekly Average of Numeric Rating Scale (NRS) - Frequentist Repeated Measures (FRM) Analysis
Periodo de tiempo: Baseline, Week 12
  • The NRS was a single-item numeric scale used to describe pain severity. Participants were asked to rate their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine; a higher score indicates worse outcome (greater pain severity).
  • The Least Squares (LS) Mean was calculated using a frequentist repeated measures (FRM) analysis, where Change = treatment, time interval, treatment * time interval, region, average baseline pain severity category (mild or moderate versus [vs.] severe), concurrent use of allowed concomitant medication as entered in IWRS (yes versus no).
Baseline, Week 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Change From Baseline in Worst Pain Intensity (WPI) as Measured by Weekly Average of Numeric Rating Scale (NRS)
Periodo de tiempo: Baseline, Week 12
  • The NRS was a single-item numeric scale used to describe pain severity. Participants were asked to rate their worst pain intensity over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine; a higher score indicates worse outcome (greater pain severity).
  • The LS Mean was calculated using an FRM analysis, where Change = treatment, time interval, treatment * time interval, region, average baseline pain severity category (mild or moderate versus severe), concurrent use of allowed concomitant medication (yes versus no based on IWRS).
Baseline, Week 12
Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS PI SF8a)
Periodo de tiempo: Baseline, Week 12
The Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS PI SF8a) was administered to measure self-reported consequences of pain on various aspects of the participant's life within the previous 7 days. The scale consists of 8 items, all measuring a single domain of pain interference, including impact on day-to-day activities, work around the home, household chores, family life, social activities, activities done for fun, enjoyment of social activities, and enjoyment of life. Each item was rated on a 5-point response scale ranging from "not at all" (1) to "very much" (5); the 8 item scores were summed to produce a raw score ranging from 8 (minimum) to 40 (maximum). The raw score was then converted to a T-score with a mean of 50 and a standard deviation of 10; higher T-scores indicate worse outcome (greater pain interference). Range cannot be specified in norm-based scores.
Baseline, Week 12
Mean Change From Baseline in Pain Interference With Sleep
Periodo de tiempo: Baseline, Week 12
  • Pain Interference with Sleep was assessed using a single-item measure: "To what extent did diabetic nerve pain interfere with your sleep last night?" Participants responded on a scale from 0 (minimum, "Not at all") to 4 (maximum, "Unable to sleep at all"); higher scores indicate worse outcome (greater sleep interference due to pain).
  • LS Mean was calculated using an FRM analysis, where Change = treatment, time interval, treatment * time interval, region, average baseline pain severity category (mild or moderate vs. severe), concurrent use of concomitant medication (yes vs. no based on IWRS).
Baseline, Week 12
Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System Physical Functioning Short Form 10a (PROMIS PF SF10a)
Periodo de tiempo: Baseline, Week 12
The PROMIS PF SF10a was administered to assess self-reported physical function and physical activities across 10 items at the present time.The first 5 items assess current physical limitations (health in doing vigorous activities, walking more than one mile, climbing stairs, lifting or carrying groceries, and bending, kneeling, or stooping), each rated on a 5-point Likert scale ranging from "not at all" to "cannot do". The remaining 5 items are self-reported ability to perform specific physical activities such as chores,dressing themselves, bathing,sitting on and getting up from the toilet, each rated on a 5-point likert scale ranging from "without any difficulty" to "unable to do". The 10 item scores were summed to produce a raw score ranging from 10 (minimum) to 50 (maximum).The raw score was then converted to a T-score with a mean of 50 and a standard deviation of 10; higher T-scores indicate better outcome (greater physical function).Range cannot be specified in norm-based scores.
Baseline, Week 12
Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF8b)
Periodo de tiempo: Baseline, Week 12
The Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF8b) was administered to assess perceptions of sleep quality, sleep depth, and restoration associated with sleep within the previous 7 days, including perceived difficulties and concerns with getting to sleep or staying asleep, and perceptions of the adequacy of and satisfaction with sleep. The scale consists of 8 items, all measuring a single domain of sleep disturbance. Each item was rated on a 5-point response scale ranging from "not at all" to "very much," "never" to "always," or "very poor" to "very good"; the 8 item scores were summed to produce a raw score ranging from 8 (minimum) to 40 (maximum). The raw score was then converted to a T-score with a mean of 50 and a standard deviation of 10; higher T-scores indicate worse outcome (greater sleep disturbance). Range cannot be specified in norm-based scores.
Baseline, Week 12
Mean Change From Baseline in Patient's Global Impression of Illness Severity as Measured by Patient's Global Impression-Severity (PGI-Severity)
Periodo de tiempo: Baseline, Week 12
  • The Patient's Global Impression-Severity (PGI-Severity) is a patient-reported single-item instrument designed to assess the participant's severity of diabetic nerve pain over the past week. The single item is rated on a 5-point Likert scale ranging from 1 (minimum, "very severe") to 5 (maximum, "none"); higher scores indicate better outcome (less pain severity).
  • The LS Mean was calculated using an FRM analysis, where Change = treatment, time interval, treatment * time interval, region, average baseline pain severity category (mild or moderate vs. severe), concurrent use of allowed concomitant medication (yes vs. no based on IWRS).
Baseline, Week 12
Mean Change From Baseline in Patient's Global Impression (PGI) of Illness Status as Measured by PGI-Status
Periodo de tiempo: Baseline, Week 12
The Patient's Global Impression-Status (PGI-Status) is a patient-reported single-item instrument designed to assess the participant's status with diabetic nerve pain. Three PGI-Status scales were administered to assess physical activity, usual activity, and sleep disturbance. For physical activity, participants rated their status at the present time; for usual activity and sleep disturbance, participants rated their overall status over the past week. Physical activity and usual activity were each rated on a 5-point Likert scale ranging from 1 (minimum, "extremely limited") to 5 (maximum, "not at all limited"); higher scores indicate better outcome (less limitation). Sleep disturbance was rated on a 5-point Likert scale ranging from 1 (minimum, "very much") to 5 (maximum, "not at all"); higher scores indicate better outcome (less sleep disturbance).
Baseline, Week 12
Patient's Global Impression of Change as Measured by Patient's Global Impression-Change (PGI-Change)
Periodo de tiempo: Week 12
The Patient's Global Impression-Change (PGI-Change) is a patient-reported single-item instrument designed to assess the participant's rating of change in diabetic nerve pain since they began taking the study medication. Four PGI-Change scales were administered to assess diabetic nerve pain's impact on physical activities, usual activities, sleep disturbance, and overall change. Each item was rated on a 5-point Likert scale ranging from 1 (minimum, "much worse") to 5 (maximum, "much better"); higher scores indicate better outcome (greater improvement).
Week 12
Mean Change From Baseline in Neuropathy Total Symptom Score-6 (NTSS-6)
Periodo de tiempo: Baseline, Week 12
The NTSS-6 assessed the frequency and intensity of 6 diabetic peripheral neuropathic symptoms over the previous 7 days: (1) numbness and/or insensitivity, (2) prickling and/or tingling sensation, (3) burning sensation, (4) aching pain and/or tightness, (5) sharp, shooting, lancinating pain, and (6) allodynia and/or hyperalgesia. Each of the 6 symptoms was rated on two separate response scales: an intensity scale (Does not apply [0], Mild [1], Moderate [2], or Severe [3]) and a frequency scale (Never [0], Occasionally, less than 1/3 of the time [0], Often, 1/3 to 2/3 of the time [0.33], or Almost always, more than 2/3 of the time [0.66]). The total score was calculated as the weighted sum across all 6 symptoms, where intensity was given a weight of 1 and frequency was given a weight of 1/3, yielding a total score ranging from 0 (minimum, no symptoms) to 21.96 (maximum, most severe); higher scores indicate worse outcome (greater neuropathic symptom burden).
Baseline, Week 12
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage
Periodo de tiempo: Week 12
Acetaminophen was used as rescue medication during the treatment period. The total amount of rescue medication use was summarized as the average daily dosage at Week 12.
Week 12
Percentage of Participants With at Least One Use of Rescue Medication
Periodo de tiempo: Week 12
Acetaminophen was used as rescue medication during the treatment period. The percentage of participants with at least one use of rescue medication at Week 12 was reported.
Week 12
Pharmacokinetics (PK): Plasma Concentration of Mazisotine
Periodo de tiempo: Postdose at Week 12
Mazisotine plasma concentration was reported. The Measure Type was Median and the Measure of Dispersion/Precision was Inter-Quartile Range, where the lower and upper limits represented the 5th and 95th percentiles, respectively.
Postdose at Week 12

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eli Lilly and Company

Investigadores

  • Director de estudio: 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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de octubre de 2023

Finalización primaria (Actual)

11 de junio de 2025

Finalización del estudio (Actual)

11 de junio de 2025

Fechas de registro del estudio

Enviado por primera vez

3 de octubre de 2023

Primero enviado que cumplió con los criterios de control de calidad

3 de octubre de 2023

Publicado por primera vez (Actual)

10 de octubre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 18509
  • J2P-MC-LXBD (Otro identificador: Eli Lilly and Company)
  • 2023-506127-29-00 (Otro identificador: EU Trial Number)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Los datos anonimizados a nivel de paciente individual se proporcionarán en un entorno de acceso seguro tras la aprobación de una propuesta de investigación y un acuerdo de intercambio de datos firmado.

Marco de tiempo para compartir IPD

Los datos están disponibles 6 meses después de la publicación principal y aprobación de la indicación estudiada en los EE. UU. y la Unión Europea (UE), lo que ocurra más tarde. Los datos estarán disponibles indefinidamente para su solicitud.

Criterios de acceso compartido de IPD

Una propuesta de investigación debe ser aprobada por un panel de revisión independiente y los investigadores deben firmar un acuerdo de intercambio de datos.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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