Een klinisch onderzoek naar efinopegdutide bij mensen met gecompenseerde cirrose als gevolg van steatohepatitis (MK-6024-017)
Fase 2a gerandomiseerde, dubbelblinde, placebogecontroleerde studie om de werkzaamheid en veiligheid van Efinopegdutide (MK-6024) te evalueren bij volwassenen met gecompenseerde cirrose secundair aan metabole disfunctie-geassocieerde steatohepatitis
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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South Australia
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Adelaide, South Australia, Australië, 5042
- Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202)
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Victoria
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Melbourne, Victoria, Australië, 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, Frankrijk, 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, Frankrijk, 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, Frankrijk, 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, Frankrijk, 92110
- Hôpital Beaujon-Hépatologie ( Site 0703)
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Limousin
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Limoges, Limousin, Frankrijk, 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, Japan, 602-8566
- University Hospital,Kyoto Prefectural University of Medicine ( Site 1404)
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Osaka, Japan, 545-8586
- Osaka Metropolitan University Hospital ( Site 1403)
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Saga, Japan, 849-8501
- Saga University Hospital ( Site 1405)
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Kanagawa
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Kawasaki, Kanagawa, Japan, 215-0026
- Shinyurigaoka General Hospital ( Site 1401)
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Yokohama, Kanagawa, Japan, 236-0004
- Yokohama City University Hospital ( Site 1402)
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Guaynabo, Puerto Rico, 00968
- ISIS CLINICAL RESEARCH CENTER ( Site 0606)
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San Juan, Puerto Rico, 00909
- Klinical Investigations Group-Clinical Research ( Site 0601)
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Barcelona, Spanje, 08035
- Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1002)
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Madrid, Spanje, 28046
- Hospital Universitario La Paz-HEPATOLOGIA ( Site 1005)
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Seville, Spanje, 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, Spanje, 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, Spanje, 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, Spanje, 13700
- Hospital General de Tomelloso-Aparato Digestivo ( Site 1006)
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La Coruna
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A Coruña, La Coruna, Spanje, 15006
- CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 1007)
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Santiago de Compostela, La Coruna, Spanje, 15706
- CHUS - Hospital Clinico Universitario ( Site 1011)
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Bangkok
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Bangkok, Bangkok, Thailand, 10330
- Chulalongkorn University ( Site 1301)
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Bangkok, Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 1302)
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London, City of
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London, London, City of, Verenigd Koninkrijk, SE5 9RL
- King's College Hospital ( Site 1104)
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Scotland
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Aberdeen, Scotland, Verenigd Koninkrijk, AB25 2ZN
- Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 1102)
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Arizona
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Chandler, Arizona, Verenigde Staten, 85224
- The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)
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Flagstaff, Arizona, Verenigde Staten, 86001
- Arizona Clinical Trials ( Site 0158)
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Peoria, Arizona, Verenigde Staten, 85381
- The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)
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Tucson, Arizona, Verenigde Staten, 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, Verenigde Staten, 91105
- California Liver Research Institute ( Site 0113)
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San Diego, California, Verenigde Staten, 92120
- Acclaim Clinical Research ( Site 0137)
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Van Nuys, California, Verenigde Staten, 91405
- Velocity Clinical Research, Panorama City ( Site 0124)
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Colorado
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Littleton, Colorado, Verenigde Staten, 80120
- Rocky Mountain Gastroenterology ( Site 0127)
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Florida
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Bradenton, Florida, Verenigde Staten, 34209
- Synergy Healthcare ( Site 0118)
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Homestead, Florida, Verenigde Staten, 33033
- Homestead Associates in Research, Inc. ( Site 0139)
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Lakewood Rch, Florida, Verenigde Staten, 34211
- Florida Research Institute ( Site 0116)
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Miami Lakes, Florida, Verenigde Staten, 33016
- Floridian Clinical Research, LLC ( Site 0109)
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Georgia
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Dalton, Georgia, Verenigde Staten, 30720
- Southeast Clinical Research Center ( Site 0119)
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Louisiana
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Bastrop, Louisiana, Verenigde Staten, 71220
- Delta Research Partners ( Site 0160)
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Shreveport, Louisiana, Verenigde Staten, 71105
- Louisiana Research Center ( Site 0161)
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Maryland
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Glen Burnie, Maryland, Verenigde Staten, 21061
- Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130)
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Rockville, Maryland, Verenigde Staten, 20854
- Velocity Clinical Research Rockville ( Site 0143)
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Michigan
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Ypsilanti, Michigan, Verenigde Staten, 48197
- Huron Gastroenterology ( Site 0102)
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89101
- The Machuca Foundation ( Site 0115)
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Las Vegas, Nevada, Verenigde Staten, 89109
- Excel Clinical Research, LLC ( Site 0101)
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87109
- Southwest Gastroenterology Associates ( Site 0129)
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North Carolina
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Fayetteville, North Carolina, Verenigde Staten, 28304
- Coastal Research Institute - Fayetteville ( Site 0159)
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Morehead City, North Carolina, Verenigde Staten, 28557
- Lucas Research, Inc ( Site 0105)
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Texas
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Arlington, Texas, Verenigde Staten, 76012
- Texas Clinical Research Institute ( Site 0126)
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Austin, Texas, Verenigde Staten, 78757
- Pinnacle Clinical Research ( Site 0104)
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Corpus Christi, Texas, Verenigde Staten, 78404
- Pinnacle Clinical Research-Corpus Christi ( Site 0156)
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Dallas, Texas, Verenigde Staten, 75230
- Zenos Clinical Research ( Site 0136)
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Fort Worth, Texas, Verenigde Staten, 76104
- GI Alliance Department of Research ( Site 0162)
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Houston, Texas, Verenigde Staten, 77079
- Houston Research Institute ( Site 0117)
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Houston, Texas, Verenigde Staten, 77004
- Houston Research Institute ( Site 0172)
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San Antonio, Texas, Verenigde Staten, 78215
- American Research Corporation ( Site 0131)
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San Antonio, Texas, Verenigde Staten, 78229
- Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125)
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Virginia
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Charlottesville, Virginia, Verenigde Staten, 22908
- University of Virginia Health System ( Site 0164)
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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
Andere namen:
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Placebo-vergelijker: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change from Baseline in Liver Fat Content (LFC) at Week 28
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from Baseline in Iron-corrected T1 (cT1) at Week 28
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Medical Director, Merck Sharp & Dohme LLC
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 6024-017
- MK-6024-017 (Andere identificatie: MSD)
- jRCT2031240217 (Register-ID: jRCT)
- U1111-1302-7589 (Register-ID: UTN)
- 2024-510923-20-00 (Register-ID: EU CT)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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