Eine klinische Studie zu Efinopegdutid bei Menschen mit kompensierter Zirrhose aufgrund von Steatohepatitis (MK-6024-017)
Randomisierte, doppelblinde, placebokontrollierte Phase-2a-Studie zur Bewertung der Wirksamkeit und Sicherheit von Efinopegdutid (MK-6024) bei Erwachsenen mit kompensierter Zirrhose als Folge einer metabolischen Dysfunktion-assoziierten 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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South Australia
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Adelaide, South Australia, Australien, 5042
- Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202)
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Victoria
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Melbourne, Victoria, Australien, 3065
- St Vincent's Hospital-Gastroenterology Department ( Site 1205)
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Frankreich, 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, Frankreich, 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, Frankreich, 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, Frankreich, 92110
- Hôpital Beaujon-Hépatologie ( Site 0703)
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Limousin
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Limoges, Limousin, Frankreich, 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, 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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Ontario
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Toronto, Ontario, Kanada, M5G 2C4
- Toronto General Hospital ( Site 0207)
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Quebec
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Québec, Quebec, Kanada, G1V 4T3
- Diex Recherche Quebec ( Site 0204)
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Cundinamarca
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Bogotá, Cundinamarca, Kolumbien, 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, Kolumbien, 760032
- Fundación Valle del Lili ( Site 0402)
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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, Spanien, 08035
- Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1002)
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Madrid, Spanien, 28046
- Hospital Universitario La Paz-HEPATOLOGIA ( Site 1005)
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Seville, Spanien, 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, Spanien, 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, Spanien, 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, Spanien, 13700
- Hospital General de Tomelloso-Aparato Digestivo ( Site 1006)
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La Coruna
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A Coruña, La Coruna, Spanien, 15006
- CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 1007)
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Santiago de Compostela, La Coruna, Spanien, 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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Arizona
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Chandler, Arizona, Vereinigte Staaten, 85224
- The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)
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Flagstaff, Arizona, Vereinigte Staaten, 86001
- Arizona Clinical Trials ( Site 0158)
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Peoria, Arizona, Vereinigte Staaten, 85381
- The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)
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Tucson, Arizona, Vereinigte Staaten, 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, Vereinigte Staaten, 91105
- California Liver Research Institute ( Site 0113)
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San Diego, California, Vereinigte Staaten, 92120
- Acclaim Clinical Research ( Site 0137)
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Van Nuys, California, Vereinigte Staaten, 91405
- Velocity Clinical Research, Panorama City ( Site 0124)
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Colorado
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Littleton, Colorado, Vereinigte Staaten, 80120
- Rocky Mountain Gastroenterology ( Site 0127)
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Florida
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Bradenton, Florida, Vereinigte Staaten, 34209
- Synergy Healthcare ( Site 0118)
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Homestead, Florida, Vereinigte Staaten, 33033
- Homestead Associates in Research, Inc. ( Site 0139)
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Lakewood Rch, Florida, Vereinigte Staaten, 34211
- Florida Research Institute ( Site 0116)
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Miami Lakes, Florida, Vereinigte Staaten, 33016
- Floridian Clinical Research, LLC ( Site 0109)
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Georgia
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Dalton, Georgia, Vereinigte Staaten, 30720
- Southeast Clinical Research Center ( Site 0119)
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Louisiana
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Bastrop, Louisiana, Vereinigte Staaten, 71220
- Delta Research Partners ( Site 0160)
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Shreveport, Louisiana, Vereinigte Staaten, 71105
- Louisiana Research Center ( Site 0161)
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Maryland
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Glen Burnie, Maryland, Vereinigte Staaten, 21061
- Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130)
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Rockville, Maryland, Vereinigte Staaten, 20854
- Velocity Clinical Research Rockville ( Site 0143)
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Michigan
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Ypsilanti, Michigan, Vereinigte Staaten, 48197
- Huron Gastroenterology ( Site 0102)
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Nevada
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Las Vegas, Nevada, Vereinigte Staaten, 89101
- The Machuca Foundation ( Site 0115)
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Las Vegas, Nevada, Vereinigte Staaten, 89109
- Excel Clinical Research, LLC ( Site 0101)
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New Mexico
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Albuquerque, New Mexico, Vereinigte Staaten, 87109
- Southwest Gastroenterology Associates ( Site 0129)
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North Carolina
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Fayetteville, North Carolina, Vereinigte Staaten, 28304
- Coastal Research Institute - Fayetteville ( Site 0159)
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Morehead City, North Carolina, Vereinigte Staaten, 28557
- Lucas Research, Inc ( Site 0105)
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Texas
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Arlington, Texas, Vereinigte Staaten, 76012
- Texas Clinical Research Institute ( Site 0126)
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Austin, Texas, Vereinigte Staaten, 78757
- Pinnacle Clinical Research ( Site 0104)
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Corpus Christi, Texas, Vereinigte Staaten, 78404
- Pinnacle Clinical Research-Corpus Christi ( Site 0156)
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Dallas, Texas, Vereinigte Staaten, 75230
- Zenos Clinical Research ( Site 0136)
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Fort Worth, Texas, Vereinigte Staaten, 76104
- GI Alliance Department of Research ( Site 0162)
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Houston, Texas, Vereinigte Staaten, 77079
- Houston Research Institute ( Site 0117)
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Houston, Texas, Vereinigte Staaten, 77004
- Houston Research Institute ( Site 0172)
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San Antonio, Texas, Vereinigte Staaten, 78215
- American Research Corporation ( Site 0131)
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San Antonio, Texas, Vereinigte Staaten, 78229
- Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125)
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Virginia
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Charlottesville, Virginia, Vereinigte Staaten, 22908
- University of Virginia Health System ( Site 0164)
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London, City of
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London, London, City of, Vereinigtes Königreich, SE5 9RL
- King's College Hospital ( Site 1104)
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Scotland
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Aberdeen, Scotland, Vereinigtes Königreich, AB25 2ZN
- Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 1102)
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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
Andere Namen:
|
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Placebo-Komparator: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from Baseline in Liver Fat Content (LFC) at Week 28
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from Baseline in Iron-corrected T1 (cT1) at Week 28
Zeitfenster: 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
|
|
Change from Baseline in Enhanced Liver Fibrosis (ELF) score at Week 28
Zeitfenster: 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
Zeitfenster: 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
|
|
Change from Baseline in Fibrosis-4 index (FIB-4) at Week 28
Zeitfenster: 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
Zeitfenster: Baseline and up to 28 weeks
|
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
Zeitfenster: Baseline and up to approximately 28 weeks
|
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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Medical Director, Merck Sharp & Dohme LLC
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 6024-017
- MK-6024-017 (Andere Kennung: MSD)
- jRCT2031240217 (Registrierungskennung: jRCT)
- U1111-1302-7589 (Registrierungskennung: UTN)
- 2024-510923-20-00 (Registrierungskennung: EU CT)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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