Uno studio clinico sull'efinopegdutide in persone con cirrosi compensata dovuta a steatoepatite (MK-6024-017)
Studio di fase 2a randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza dell'efinopegdutide (MK-6024) negli adulti con cirrosi compensata secondaria a steatoepatite associata a disfunzione metabolica
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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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South Australia
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Adelaide, South Australia, Australia, 5042
- Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202)
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Victoria
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Melbourne, Victoria, Australia, 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, Colombia, 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, Colombia, 760032
- Fundación Valle del Lili ( Site 0402)
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Francia, 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, Francia, 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, Francia, 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, Francia, 92110
- Hôpital Beaujon-Hépatologie ( Site 0703)
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Limousin
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Limoges, Limousin, Francia, 87042
- Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-Hépato-gastroentérologie ( Site 0702)
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Kyoto, Giappone, 602-8566
- University Hospital,Kyoto Prefectural University of Medicine ( Site 1404)
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Osaka, Giappone, 545-8586
- Osaka Metropolitan University Hospital ( Site 1403)
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Saga, Giappone, 849-8501
- Saga University Hospital ( Site 1405)
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Kanagawa
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Kawasaki, Kanagawa, Giappone, 215-0026
- Shinyurigaoka General Hospital ( Site 1401)
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Yokohama, Kanagawa, Giappone, 236-0004
- Yokohama City University Hospital ( Site 1402)
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Haifa, Israele, 3109601
- Rambam Health Care Campus ( Site 0801)
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Haifa, Israele, 3436212
- Carmel Hospital-Liver Unit ( Site 0802)
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Jerusalem, Israele, 9103102
- Shaare Zedek Medical Center ( Site 0805)
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Petah Tikva, Israele, 4925110
- Maccabi Health Services - Petah Tikva ( Site 0804)
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Tel Aviv, Israele, 6789140
- Assuta Medical Center ( Site 0806)
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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, Regno Unito, SE5 9RL
- King's College Hospital ( Site 1104)
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Scotland
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Aberdeen, Scotland, Regno Unito, AB25 2ZN
- Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 1102)
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Barcelona, Spagna, 08035
- Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1002)
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Madrid, Spagna, 28046
- Hospital Universitario La Paz-HEPATOLOGIA ( Site 1005)
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Seville, Spagna, 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, Spagna, 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, Spagna, 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, Spagna, 13700
- Hospital General de Tomelloso-Aparato Digestivo ( Site 1006)
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La Coruna
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A Coruña, La Coruna, Spagna, 15006
- CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 1007)
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Santiago de Compostela, La Coruna, Spagna, 15706
- CHUS - Hospital Clinico Universitario ( Site 1011)
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Arizona
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Chandler, Arizona, Stati Uniti, 85224
- The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)
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Flagstaff, Arizona, Stati Uniti, 86001
- Arizona Clinical Trials ( Site 0158)
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Peoria, Arizona, Stati Uniti, 85381
- The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)
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Tucson, Arizona, Stati Uniti, 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, Stati Uniti, 91105
- California Liver Research Institute ( Site 0113)
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San Diego, California, Stati Uniti, 92120
- Acclaim Clinical Research ( Site 0137)
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Van Nuys, California, Stati Uniti, 91405
- Velocity Clinical Research, Panorama City ( Site 0124)
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Colorado
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Littleton, Colorado, Stati Uniti, 80120
- Rocky Mountain Gastroenterology ( Site 0127)
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Florida
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Bradenton, Florida, Stati Uniti, 34209
- Synergy Healthcare ( Site 0118)
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Homestead, Florida, Stati Uniti, 33033
- Homestead Associates in Research, Inc. ( Site 0139)
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Lakewood Rch, Florida, Stati Uniti, 34211
- Florida Research Institute ( Site 0116)
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Miami Lakes, Florida, Stati Uniti, 33016
- Floridian Clinical Research, LLC ( Site 0109)
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Georgia
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Dalton, Georgia, Stati Uniti, 30720
- Southeast Clinical Research Center ( Site 0119)
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Louisiana
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Bastrop, Louisiana, Stati Uniti, 71220
- Delta Research Partners ( Site 0160)
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Shreveport, Louisiana, Stati Uniti, 71105
- Louisiana Research Center ( Site 0161)
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Maryland
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Glen Burnie, Maryland, Stati Uniti, 21061
- Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130)
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Rockville, Maryland, Stati Uniti, 20854
- Velocity Clinical Research Rockville ( Site 0143)
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Michigan
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Ypsilanti, Michigan, Stati Uniti, 48197
- Huron Gastroenterology ( Site 0102)
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89101
- The Machuca Foundation ( Site 0115)
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Las Vegas, Nevada, Stati Uniti, 89109
- Excel Clinical Research, LLC ( Site 0101)
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87109
- Southwest Gastroenterology Associates ( Site 0129)
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North Carolina
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Fayetteville, North Carolina, Stati Uniti, 28304
- Coastal Research Institute - Fayetteville ( Site 0159)
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Morehead City, North Carolina, Stati Uniti, 28557
- Lucas Research, Inc ( Site 0105)
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Texas
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Arlington, Texas, Stati Uniti, 76012
- Texas Clinical Research Institute ( Site 0126)
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Austin, Texas, Stati Uniti, 78757
- Pinnacle Clinical Research ( Site 0104)
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Corpus Christi, Texas, Stati Uniti, 78404
- Pinnacle Clinical Research-Corpus Christi ( Site 0156)
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Dallas, Texas, Stati Uniti, 75230
- Zenos Clinical Research ( Site 0136)
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Fort Worth, Texas, Stati Uniti, 76104
- GI Alliance Department of Research ( Site 0162)
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Houston, Texas, Stati Uniti, 77079
- Houston Research Institute ( Site 0117)
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Houston, Texas, Stati Uniti, 77004
- Houston Research Institute ( Site 0172)
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San Antonio, Texas, Stati Uniti, 78215
- American Research Corporation ( Site 0131)
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San Antonio, Texas, Stati Uniti, 78229
- Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125)
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22908
- University of Virginia Health System ( Site 0164)
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Bangkok
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Bangkok, Bangkok, Tailandia, 10330
- Chulalongkorn University ( Site 1301)
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Bangkok, Bangkok, Tailandia, 10700
- Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 1302)
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: 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
Altri nomi:
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Comparatore 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from Baseline in Liver Fat Content (LFC) at Week 28
Lasso di tempo: 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)
Lasso di tempo: Up to approximately 36 weeks
|
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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from Baseline in Iron-corrected T1 (cT1) at Week 28
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Medical Director, Merck Sharp & Dohme LLC
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 6024-017
- MK-6024-017 (Altro identificatore: MSD)
- jRCT2031240217 (Identificatore di registro: jRCT)
- U1111-1302-7589 (Identificatore di registro: UTN)
- 2024-510923-20-00 (Identificatore di registro: EU CT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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