Um estudo clínico de efinopegdutida em pessoas com cirrose compensada devido a esteatohepatite (MK-6024-017)
Estudo de fase 2a randomizado, duplo-cego e controlado por placebo para avaliar a eficácia e segurança da efinopegdutida (MK-6024) em adultos com cirrose compensada secundária à esteatohepatite associada à disfunção metabólica
Researchers are looking for ways to treat a type of liver disease caused by elevated liver fat, called metabolic dysfunction-associated steatohepatitis (MASH). MASH was formerly called non-alcoholic steatohepatitis (NASH). Researchers want to learn if a study medicine called efinopegdutide can treat MASH.The goals of this study are to learn:
- If efinopegdutide can lower the amount of fat, inflammation, and scarring (fibrosis) in the liver
- About the safety of efinopegdutide and how well people tolerate it
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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South Australia
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Adelaide, South Australia, Austrália, 5042
- Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202)
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Victoria
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Melbourne, Victoria, Austrália, 3065
- St Vincent's Hospital-Gastroenterology Department ( Site 1205)
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Ontario
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Toronto, Ontario, Canadá, M5G 2C4
- Toronto General Hospital ( Site 0207)
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Quebec
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Québec, Quebec, Canadá, G1V 4T3
- Diex Recherche Quebec ( Site 0204)
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Cundinamarca
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Bogotá, Cundinamarca, Colômbia, 110111
- Fundacion Santa Fe de Bogota ( Site 0403)
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colômbia, 760032
- Fundación Valle del Lili ( Site 0402)
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Barcelona, Espanha, 08035
- Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1002)
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Madrid, Espanha, 28046
- Hospital Universitario La Paz-HEPATOLOGIA ( Site 1005)
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Seville, Espanha, 41013
- HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos clinicos de Aparato Digestivo ( Site 1001)
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Cantabria
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Santander, Cantabria, Espanha, 39005
- Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 1004)
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Castille and León
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Valladolid, Castille and León, Espanha, 47010
- Hospital Clínico Universitario de Valladolid-Servicio de Endocrinologia y Nutricion ( Site 1008)
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Ciudad Real
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Tomelloso, Ciudad Real, Espanha, 13700
- Hospital General de Tomelloso-Aparato Digestivo ( Site 1006)
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La Coruna
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A Coruña, La Coruna, Espanha, 15006
- CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 1007)
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Santiago de Compostela, La Coruna, Espanha, 15706
- CHUS - Hospital Clinico Universitario ( Site 1011)
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Arizona
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Chandler, Arizona, Estados Unidos, 85224
- The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)
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Flagstaff, Arizona, Estados Unidos, 86001
- Arizona Clinical Trials ( Site 0158)
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Peoria, Arizona, Estados Unidos, 85381
- The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)
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Tucson, Arizona, Estados Unidos, 85712
- The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 0111)
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California
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Pasadena, California, Estados Unidos, 91105
- California Liver Research Institute ( Site 0113)
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San Diego, California, Estados Unidos, 92120
- Acclaim Clinical Research ( Site 0137)
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Van Nuys, California, Estados Unidos, 91405
- Velocity Clinical Research, Panorama City ( Site 0124)
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Colorado
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Littleton, Colorado, Estados Unidos, 80120
- Rocky Mountain Gastroenterology ( Site 0127)
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Florida
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Bradenton, Florida, Estados Unidos, 34209
- Synergy Healthcare ( Site 0118)
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Homestead, Florida, Estados Unidos, 33033
- Homestead Associates in Research, Inc. ( Site 0139)
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Lakewood Rch, Florida, Estados Unidos, 34211
- Florida Research Institute ( Site 0116)
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Miami Lakes, Florida, Estados Unidos, 33016
- Floridian Clinical Research, LLC ( Site 0109)
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Georgia
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Dalton, Georgia, Estados Unidos, 30720
- Southeast Clinical Research Center ( Site 0119)
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Louisiana
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Bastrop, Louisiana, Estados Unidos, 71220
- Delta Research Partners ( Site 0160)
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Shreveport, Louisiana, Estados Unidos, 71105
- Louisiana Research Center ( Site 0161)
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Maryland
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Glen Burnie, Maryland, Estados Unidos, 21061
- Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130)
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Rockville, Maryland, Estados Unidos, 20854
- Velocity Clinical Research Rockville ( Site 0143)
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Michigan
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Ypsilanti, Michigan, Estados Unidos, 48197
- Huron Gastroenterology ( Site 0102)
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89101
- The Machuca Foundation ( Site 0115)
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Las Vegas, Nevada, Estados Unidos, 89109
- Excel Clinical Research, LLC ( Site 0101)
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87109
- Southwest Gastroenterology Associates ( Site 0129)
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North Carolina
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Fayetteville, North Carolina, Estados Unidos, 28304
- Coastal Research Institute - Fayetteville ( Site 0159)
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Morehead City, North Carolina, Estados Unidos, 28557
- Lucas Research, Inc ( Site 0105)
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Texas
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Arlington, Texas, Estados Unidos, 76012
- Texas Clinical Research Institute ( Site 0126)
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Austin, Texas, Estados Unidos, 78757
- Pinnacle Clinical Research ( Site 0104)
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Corpus Christi, Texas, Estados Unidos, 78404
- Pinnacle Clinical Research-Corpus Christi ( Site 0156)
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Dallas, Texas, Estados Unidos, 75230
- Zenos Clinical Research ( Site 0136)
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Fort Worth, Texas, Estados Unidos, 76104
- GI Alliance Department of Research ( Site 0162)
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Houston, Texas, Estados Unidos, 77079
- Houston Research Institute ( Site 0117)
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Houston, Texas, Estados Unidos, 77004
- Houston Research Institute ( Site 0172)
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San Antonio, Texas, Estados Unidos, 78215
- American Research Corporation ( Site 0131)
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San Antonio, Texas, Estados Unidos, 78229
- Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125)
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
- University of Virginia Health System ( Site 0164)
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Alpes-Maritimes
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Nice, Alpes-Maritimes, França, 06202
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol ( Site 0704)
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Aquitaine
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Pessac, Aquitaine, França, 33600
- CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0701)
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, França, 69004
- Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0705)
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Hauts-de-Seine
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Clichy, Hauts-de-Seine, França, 92110
- Hôpital Beaujon-Hépatologie ( Site 0703)
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Limousin
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Limoges, Limousin, França, 87042
- Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-Hépato-gastroentérologie ( Site 0702)
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Haifa, Israel, 3109601
- Rambam Health Care Campus ( Site 0801)
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Haifa, Israel, 3436212
- Carmel Hospital-Liver Unit ( Site 0802)
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Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center ( Site 0805)
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Petah Tikva, Israel, 4925110
- Maccabi Health Services - Petah Tikva ( Site 0804)
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Tel Aviv, Israel, 6789140
- Assuta Medical Center ( Site 0806)
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Kyoto, Japão, 602-8566
- University Hospital,Kyoto Prefectural University of Medicine ( Site 1404)
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Osaka, Japão, 545-8586
- Osaka Metropolitan University Hospital ( Site 1403)
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Saga, Japão, 849-8501
- Saga University Hospital ( Site 1405)
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Kanagawa
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Kawasaki, Kanagawa, Japão, 215-0026
- Shinyurigaoka General Hospital ( Site 1401)
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Yokohama, Kanagawa, Japão, 236-0004
- Yokohama City University Hospital ( Site 1402)
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Guaynabo, Porto Rico, 00968
- ISIS CLINICAL RESEARCH CENTER ( Site 0606)
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San Juan, Porto Rico, 00909
- Klinical Investigations Group-Clinical Research ( Site 0601)
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London, City of
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London, London, City of, Reino Unido, SE5 9RL
- King's College Hospital ( Site 1104)
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Scotland
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Aberdeen, Scotland, Reino Unido, AB25 2ZN
- Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 1102)
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Bangkok
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Bangkok, Bangkok, Tailândia, 10330
- Chulalongkorn University ( Site 1301)
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Bangkok, Bangkok, Tailândia, 10700
- Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 1302)
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH)
- Has either type 2 diabetes that is controlled by diet or medication, or does not have type 2 diabetes
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has history of a liver disease other than MASH, for example, Hepatitis B or C, drug-induced liver disease, or autoimmune liver disease
- Has history of type 1 diabetes
- Had a bariatric surgical procedure less than 5 years before entry into the study
- History of pancreatitis
- Major illnesses like recent (within 6 months of study entry) episodes of heart problems, such as congestive heart failure, unstable angina, heart attack, stroke, or mini-stroke
Plano de estudo
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 |
|---|---|
|
Experimental: Efinopegdutide
Participants will start efinopegdutide once a week at the lowest dose level. Then, the dose level will go up every month for three months until they are getting the highest dose level. Efinopegdutide is given as an injection under the skin (subcutaneous injection) for 28 weeks. |
Efinopegdutide is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks
Outros nomes:
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Comparador de Placebo: Placebo
Participants will receive placebo once a week. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of a study medicine. Placebo is given as an injection under the skin (subcutaneous injection) for 28 weeks. |
Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from Baseline in Liver Fat Content (LFC) at Week 28
Prazo: Baseline and 28 weeks
|
Researchers will measure the change in the amount of fat in the liver using magnetic resonance imaging (MRI) after about 7 months of treatment. The change in MRI-Estimated proton density fat fraction (PDFF) will be measured from baseline to 28 weeks. |
Baseline and 28 weeks
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Percentage of Participants Who Experienced an Adverse Event (AE)
Prazo: Up to approximately 36 weeks
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An AE is a health problem that happens or worsens during the study |
Up to approximately 36 weeks
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Percentage of Participants Discontinuing Study Medication Due to an AE
Prazo: Up to approximately 28 weeks
|
An AE is a health problem that happens or worsens during a study. The percentage of participants who stop study treatment due to an AE will be reported. |
Up to approximately 28 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from Baseline in Iron-corrected T1 (cT1) at Week 28
Prazo: Baseline and up to 28 Weeks
|
Researchers will measure the change in liver inflammation and scarring (fibrosis) after about 7 months of treatment. MRI measurement of cT1 mapping will be used to indicate the amount of liver inflammation and fibrosis. The change in cT1 mapping from baseline to 28 weeks will be presented. |
Baseline and up to 28 Weeks
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Change from Baseline in Enhanced Liver Fibrosis (ELF) score at Week 28
Prazo: Baseline and up to 28 weeks
|
Researchers will measure the change in liver scarring using biomarkers. Biomarkers are substances measured in blood that show normal or abnormal activity taking place in the liver. ELF is calculated using 3 markers of hepatic extracellular matrix turnover to generate a unitless numerical score. The change from baseline in ELF up to 28 weeks will be reported. |
Baseline and up to 28 weeks
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Change from Baseline in Propeptide of Type III Collagen (Pro-C3) at Week 28
Prazo: Baseline and up to 28 weeks
|
Researchers will measure the change in liver scarring using biomarkers. Pro-C3 is measured in serum; Increasing levels indicate worsening of fibrosis activity. The change in Pro-C3 from baseline to 28 weeks will be reported. |
Baseline and up to 28 weeks
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Change from Baseline in Fibrosis-4 index (FIB-4) at Week 28
Prazo: Baseline and up to 28 weeks
|
Researchers will measure the change in liver scarring using biomarkers. FIB-4 index is calculated using the participant's age and 3 serum markers (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and platelet count). The change from baseline in FIB-4 after 28 weeks will be reported. |
Baseline and up to 28 weeks
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Change from Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) at week 28
Prazo: Baseline and up to 28 weeks
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Researchers will measure the change in liver scarring using ultrasound. LSM is measured using VCTE. The change from baseline in LSM after 28 weeks will be reported. |
Baseline and up to 28 weeks
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Percent Change from Baseline in Body Weight at Week 28
Prazo: Baseline and up to approximately 28 weeks
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Body weight will be measured using a standardized, digital scale. The percent change from baseline in body weight after 28 weeks will be reported |
Baseline and up to approximately 28 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 6024-017
- MK-6024-017 (Outro identificador: MSD)
- jRCT2031240217 (Identificador de registro: jRCT)
- U1111-1302-7589 (Identificador de registro: UTN)
- 2024-510923-20-00 (Identificador de registro: EU CT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informações sobre medicamentos e dispositivos, documentos de estudo
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