Une étude clinique sur l'éfinopegdutide chez des personnes atteintes de cirrhose compensée due à une stéatohépatite (MK-6024-017)
Étude de phase 2a randomisée, en double aveugle et contrôlée par placebo pour évaluer l'efficacité et l'innocuité de l'éfinopegdutide (MK-6024) chez les adultes atteints de cirrhose compensée secondaire à une stéatohépatite associée à un dysfonctionnement métabolique
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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South Australia
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Adelaide, South Australia, Australie, 5042
- Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202)
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Victoria
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Melbourne, Victoria, Australie, 3065
- St Vincent's Hospital-Gastroenterology Department ( Site 1205)
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital ( Site 0207)
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Quebec
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Québec, Quebec, Canada, G1V 4T3
- Diex Recherche Quebec ( Site 0204)
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Cundinamarca
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Bogotá, Cundinamarca, Colombie, 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, Colombie, 760032
- Fundación Valle del Lili ( Site 0402)
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Barcelona, Espagne, 08035
- Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1002)
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Madrid, Espagne, 28046
- Hospital Universitario La Paz-HEPATOLOGIA ( Site 1005)
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Seville, Espagne, 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, Espagne, 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, Espagne, 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, Espagne, 13700
- Hospital General de Tomelloso-Aparato Digestivo ( Site 1006)
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La Coruna
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A Coruña, La Coruna, Espagne, 15006
- CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 1007)
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Santiago de Compostela, La Coruna, Espagne, 15706
- CHUS - Hospital Clinico Universitario ( Site 1011)
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Alpes-Maritimes
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Nice, Alpes-Maritimes, France, 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, France, 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, France, 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, France, 92110
- Hôpital Beaujon-Hépatologie ( Site 0703)
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Limousin
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Limoges, Limousin, France, 87042
- Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-Hépato-gastroentérologie ( Site 0702)
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Haifa, Israël, 3109601
- Rambam Health Care Campus ( Site 0801)
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Haifa, Israël, 3436212
- Carmel Hospital-Liver Unit ( Site 0802)
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Jerusalem, Israël, 9103102
- Shaare Zedek Medical Center ( Site 0805)
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Petah Tikva, Israël, 4925110
- Maccabi Health Services - Petah Tikva ( Site 0804)
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Tel Aviv, Israël, 6789140
- Assuta Medical Center ( Site 0806)
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Kyoto, Japon, 602-8566
- University Hospital,Kyoto Prefectural University of Medicine ( Site 1404)
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Osaka, Japon, 545-8586
- Osaka Metropolitan University Hospital ( Site 1403)
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Saga, Japon, 849-8501
- Saga University Hospital ( Site 1405)
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Kanagawa
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Kawasaki, Kanagawa, Japon, 215-0026
- Shinyurigaoka General Hospital ( Site 1401)
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Yokohama, Kanagawa, Japon, 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, Royaume-Uni, SE5 9RL
- King's College Hospital ( Site 1104)
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Scotland
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Aberdeen, Scotland, Royaume-Uni, AB25 2ZN
- Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 1102)
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Bangkok
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Bangkok, Bangkok, Thaïlande, 10330
- Chulalongkorn University ( Site 1301)
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Bangkok, Bangkok, Thaïlande, 10700
- Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 1302)
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Arizona
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Chandler, Arizona, États-Unis, 85224
- The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)
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Flagstaff, Arizona, États-Unis, 86001
- Arizona Clinical Trials ( Site 0158)
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Peoria, Arizona, États-Unis, 85381
- The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)
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Tucson, Arizona, États-Unis, 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, États-Unis, 91105
- California Liver Research Institute ( Site 0113)
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San Diego, California, États-Unis, 92120
- Acclaim Clinical Research ( Site 0137)
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Van Nuys, California, États-Unis, 91405
- Velocity Clinical Research, Panorama City ( Site 0124)
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Colorado
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Littleton, Colorado, États-Unis, 80120
- Rocky Mountain Gastroenterology ( Site 0127)
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Florida
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Bradenton, Florida, États-Unis, 34209
- Synergy Healthcare ( Site 0118)
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Homestead, Florida, États-Unis, 33033
- Homestead Associates in Research, Inc. ( Site 0139)
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Lakewood Rch, Florida, États-Unis, 34211
- Florida Research Institute ( Site 0116)
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Miami Lakes, Florida, États-Unis, 33016
- Floridian Clinical Research, LLC ( Site 0109)
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Georgia
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Dalton, Georgia, États-Unis, 30720
- Southeast Clinical Research Center ( Site 0119)
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Louisiana
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Bastrop, Louisiana, États-Unis, 71220
- Delta Research Partners ( Site 0160)
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Shreveport, Louisiana, États-Unis, 71105
- Louisiana Research Center ( Site 0161)
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Maryland
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Glen Burnie, Maryland, États-Unis, 21061
- Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130)
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Rockville, Maryland, États-Unis, 20854
- Velocity Clinical Research Rockville ( Site 0143)
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Michigan
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Ypsilanti, Michigan, États-Unis, 48197
- Huron Gastroenterology ( Site 0102)
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Nevada
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Las Vegas, Nevada, États-Unis, 89101
- The Machuca Foundation ( Site 0115)
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Las Vegas, Nevada, États-Unis, 89109
- Excel Clinical Research, LLC ( Site 0101)
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87109
- Southwest Gastroenterology Associates ( Site 0129)
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North Carolina
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Fayetteville, North Carolina, États-Unis, 28304
- Coastal Research Institute - Fayetteville ( Site 0159)
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Morehead City, North Carolina, États-Unis, 28557
- Lucas Research, Inc ( Site 0105)
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Texas
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Arlington, Texas, États-Unis, 76012
- Texas Clinical Research Institute ( Site 0126)
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Austin, Texas, États-Unis, 78757
- Pinnacle Clinical Research ( Site 0104)
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Corpus Christi, Texas, États-Unis, 78404
- Pinnacle Clinical Research-Corpus Christi ( Site 0156)
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Dallas, Texas, États-Unis, 75230
- Zenos Clinical Research ( Site 0136)
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Fort Worth, Texas, États-Unis, 76104
- GI Alliance Department of Research ( Site 0162)
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Houston, Texas, États-Unis, 77079
- Houston Research Institute ( Site 0117)
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Houston, Texas, États-Unis, 77004
- Houston Research Institute ( Site 0172)
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San Antonio, Texas, États-Unis, 78215
- American Research Corporation ( Site 0131)
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San Antonio, Texas, États-Unis, 78229
- Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125)
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Virginia
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Charlottesville, Virginia, États-Unis, 22908
- University of Virginia Health System ( Site 0164)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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
Autres noms:
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Comparateur 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from Baseline in Liver Fat Content (LFC) at Week 28
Délai: Baseline and 28 weeks
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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)
Délai: 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
Délai: Up to approximately 28 weeks
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from Baseline in Iron-corrected T1 (cT1) at Week 28
Délai: Baseline and up to 28 Weeks
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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
Délai: Baseline and up to 28 weeks
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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
Délai: Baseline and up to 28 weeks
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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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Medical Director, Merck Sharp & Dohme LLC
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 6024-017
- MK-6024-017 (Autre identifiant: MSD)
- jRCT2031240217 (Identificateur de registre: jRCT)
- U1111-1302-7589 (Identificateur de registre: UTN)
- 2024-510923-20-00 (Identificateur de registre: EU CT)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informations sur les médicaments et les dispositifs, documents d'étude
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