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Um estudo de LY3556050 em participantes adultos com dor neuropática periférica diabética

6 de julho de 2026 atualizado por: Eli Lilly and Company

Um estudo de fase 2, randomizado, duplo-cego, controlado por placebo e de variação de dose para avaliar LY3556050 em participantes adultos com dor neuropática periférica diabética

O objetivo principal deste estudo é determinar a segurança e eficácia do LY3556050 versus placebo em participantes com dor neuropática periférica diabética (DPNP). O estudo durará aproximadamente 24 semanas, em 3 períodos de estudo.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

404

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Coréia do Sul
    • Kyǒnggi-do
      • Sosa-gu, Kyǒnggi-do, Coréia do Sul, 14754
        • Sejong General Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Coréia do Sul, 06351
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Coréia do Sul, 01830
        • Nowon Eulji Medical Center, Eulji University
      • Seoul, Seoul-teukbyeolsi [Seoul], Coréia do Sul, 05030
        • Konkuk University Medical Center
    • Taejǒn-Kwangyǒkshi
      • Daejeon, Taejǒn-Kwangyǒkshi, Coréia do Sul, 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
  • Japão
      • Fukuoka, Japão, 819-0168
        • Kunisaki Makoto Clinic
      • Osaka, Japão, 559-0012
        • Minamiosaka Hospital
      • Shizuoka, Japão, 422-8006
        • Plumeria DM Clinic
    • Ehime
      • Matsuyama, Ehime, Japão, 790-0067
        • Matsuyama Shimin Hospital
    • Gunma
      • Maebashi, Gunma, Japão, 370-3573
        • Kikuchi Naika Clinic
    • Hiroshima
      • Kure, Hiroshima, Japão, 737-0023
        • Kure Medical Center
    • Hokkaido
      • Asahikawa, Hokkaido, Japão, 070-8530
        • Japanese Red Cross Asahikawa Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japão, 232-0064
        • Yokohama Minoru Clinic
    • Osaka
      • Suita-shi, Osaka, Japão, 565-0853
        • Medical Corporation Heishinkai OCROM Clinic
    • Saitama
      • Sokashi, Saitama, Japão, 340-0015
        • Sugiura Internal Medicine Clinic
    • Shizuoka
      • Shizuoka, Shizuoka, Japão, 424-0855
        • Suruga Clinic
    • Tokyo
      • Ootaku, Tokyo, Japão, 143-0015
        • Medical Corporation Sato Medical clinic
      • Shinjuku-ku, Tokyo, Japão, 160-0008
        • Heishinkai Medical Group ToCROM Clinic
  • Polônia
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polônia, 61-853
        • Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
    • Kuyavian-Pomeranian Voivodeship
      • Torun, Kuyavian-Pomeranian Voivodeship, Polônia, 87-100
        • MICS Centrum Medyczne Toruń
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polônia, 31-261
        • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polônia, 51-162
        • Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polônia, 00-874
        • MICS Centrum Medyczne Warszawa
      • Wyszków, Masovian Voivodeship, Polônia, 07-200
        • Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow
    • Podlaskie Voivodeship
      • Biaystok, Podlaskie Voivodeship, Polônia, 15-351
        • Zdrowie Osteo-Medic
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Polônia, 40-081
        • Centrum Medyczne Pratia Katowice
      • Katowice, Silesian Voivodeship, Polônia, 40-648
        • Pro Familia Altera
      • Ruda Śląska, Silesian Voivodeship, Polônia, 41-709
        • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polônia, 90-338
        • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
  • Tcheca
      • Olomouc, Tcheca, 779 00
        • Agentura Science Pro
    • Hradec Králové Region
      • Broumov, Hradec Králové Region, Tcheca, 550 01
        • EDUMED - Broumov
    • Praha 1
      • Prague, Praha 1, Tcheca, 11000
        • Diabet2 s.r.o., diabetologicka a interni ambulance
    • Praha 6
      • Prague, Praha 6, Tcheca, 160 00
        • Neurologická Ambulance - Forbeli
    • Praha, Hlavní Mešto
      • Prague, Praha, Hlavní Mešto, Tcheca, 160 00
        • FLEDIP - Na dlouhem lanu
      • Prague, Praha, Hlavní Mešto, Tcheca, 140 00
        • DiaVize s.r.o.
    • Rychnov Nad Kněžnou
      • European Union, Rychnov Nad Kněžnou, Tcheca, 516 01
        • Vestra Clinics

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Ter histórico e diagnóstico atual de Diabetes Tipo 1 (DT1) ou Diabetes Tipo 2 (DT2) diagnosticado há pelo menos 6 meses antes da triagem.
  • Ter um controle glicêmico estável no regime de tratamento estável do diabetes por pelo menos 90 dias antes do dia 1 com hemoglobina A1c (HbA1c) ≤10 no momento da triagem.
  • Ter histórico de dor neuropática periférica diária por pelo menos 12 semanas com base no relato do participante ou histórico médico.
  • Ter um valor de dor na escala visual analógica (VAS) ≥40 e <95 durante a triagem.
  • Ter presença de neuropatia periférica diabética de natureza simétrica e nas extremidades inferiores por ≥6 meses e diagnosticada por uma pontuação da Parte B ≥3 no Michigan Neuropathy Screening Instrument
  • Estão dispostos a manter um regime consistente de quaisquer terapias não farmacológicas de alívio da dor em andamento (por exemplo, fisioterapia) e não iniciarão nenhuma nova terapia não farmacológica de alívio da dor durante a participação no estudo.

  • Estão dispostos a descontinuar todos os medicamentos tomados para condições de dor crônica, exceto os analgésicos concomitantes permitidos pelo protocolo, durante a duração do estudo

    • Ter índice de massa corporal ≤45 quilograma/metro quadrado (kg/m²) (inclusive).
    • Os homens ou mulheres são capazes de cumprir os requisitos reprodutivos e contraceptivos?

Critério de exclusão:

  • História de outras fontes de dor potencialmente causadoras e/ou confusas que podem prejudicar a autoavaliação da dor devido ao DPNP.
  • Foram submetidos a um procedimento nos últimos 6 meses destinado a produzir perda sensorial permanente na área alvo de interesse (por exemplo, técnicas de ablação).
  • Teve câncer dentro de 2 anos após o início do estudo, exceto carcinoma basocelular cutâneo ou carcinoma espinocelular resolvido por excisão.
  • São, no julgamento do investigador, ativamente suicidas e, portanto, considerados em risco significativo de suicídio.
  • Ter, no julgamento do investigador, uma condição médica aguda, grave ou instável ou um histórico ou presença de qualquer outra doença médica que possa impedir a participação no estudo.
  • Ter um resultado positivo no teste de HIV na triagem.
  • Ter uma cirurgia planejada durante o estudo por qualquer motivo.
  • Ter um transtorno por uso de substâncias, conforme definido pelo Manual Diagnóstico e Estatístico de Transtornos Mentais (5ª edição; DSM-5; Associação Americana de Psiquiatria)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo
Participants received a matching dose of placebo administered orally twice daily (BID) over a period of 12 weeks.
Medicamento: Placebo
Administrado por via oral.
Experimental: Mazisotine 50 mg
Participants received mazisotine 50 milligrams (mg) administered orally BID over a period of 12 weeks.
Medicamento: Mazisotine
Administered orally.
Outros nomes:
  • 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.
Medicamento: Mazisotine
Administered orally.
Outros nomes:
  • 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.
Medicamento: Mazisotine
Administered orally.
Outros nomes:
  • LY3556050

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Mean Change From Baseline in Worst Pain Intensity (WPI) as Measured by Weekly Average of Numeric Rating Scale (NRS)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Eli Lilly and Company

Investigadores

  • Diretor de estudo: 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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

5 de outubro de 2023

Conclusão Primária (Real)

11 de junho de 2025

Conclusão do estudo (Real)

11 de junho de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

3 de outubro de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de outubro de 2023

Primeira postagem (Real)

10 de outubro de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Dados anonimizados de nível de paciente individual serão fornecidos em um ambiente de acesso seguro mediante aprovação de uma proposta de pesquisa e um acordo de compartilhamento de dados assinado.

Prazo de Compartilhamento de IPD

Os dados estão disponíveis 6 meses após a publicação primária e aprovação da indicação estudada nos EUA e na União Europeia (UE), o que ocorrer depois. Os dados ficarão disponíveis por tempo indeterminado para solicitação.

Critérios de acesso de compartilhamento IPD

Uma proposta de investigação deve ser aprovada por um painel de revisão independente e os investigadores devem assinar um acordo de partilha de dados.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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