En klinisk studie av Efinopegdutide hos personer med kompensert skrumplever på grunn av Steatohepatitt (MK-6024-017)
Fase 2a randomisert, dobbeltblind, placebokontrollert studie for å evaluere effektiviteten og sikkerheten til Efinopegdutide (MK-6024) hos voksne med kompensert skrumplever sekundært til metabolsk dysfunksjon-assosiert Steatohepatitt
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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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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Arizona
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Chandler, Arizona, Forente stater, 85224
- The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)
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Flagstaff, Arizona, Forente stater, 86001
- Arizona Clinical Trials ( Site 0158)
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Peoria, Arizona, Forente stater, 85381
- The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)
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Tucson, Arizona, Forente stater, 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, Forente stater, 91105
- California Liver Research Institute ( Site 0113)
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San Diego, California, Forente stater, 92120
- Acclaim Clinical Research ( Site 0137)
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Van Nuys, California, Forente stater, 91405
- Velocity Clinical Research, Panorama City ( Site 0124)
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Colorado
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Littleton, Colorado, Forente stater, 80120
- Rocky Mountain Gastroenterology ( Site 0127)
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Florida
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Bradenton, Florida, Forente stater, 34209
- Synergy Healthcare ( Site 0118)
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Homestead, Florida, Forente stater, 33033
- Homestead Associates in Research, Inc. ( Site 0139)
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Lakewood Rch, Florida, Forente stater, 34211
- Florida Research Institute ( Site 0116)
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Miami Lakes, Florida, Forente stater, 33016
- Floridian Clinical Research, LLC ( Site 0109)
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Georgia
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Dalton, Georgia, Forente stater, 30720
- Southeast Clinical Research Center ( Site 0119)
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Louisiana
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Bastrop, Louisiana, Forente stater, 71220
- Delta Research Partners ( Site 0160)
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Shreveport, Louisiana, Forente stater, 71105
- Louisiana Research Center ( Site 0161)
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Maryland
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Glen Burnie, Maryland, Forente stater, 21061
- Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130)
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Rockville, Maryland, Forente stater, 20854
- Velocity Clinical Research Rockville ( Site 0143)
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Michigan
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Ypsilanti, Michigan, Forente stater, 48197
- Huron Gastroenterology ( Site 0102)
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Nevada
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Las Vegas, Nevada, Forente stater, 89101
- The Machuca Foundation ( Site 0115)
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Las Vegas, Nevada, Forente stater, 89109
- Excel Clinical Research, LLC ( Site 0101)
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87109
- Southwest Gastroenterology Associates ( Site 0129)
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North Carolina
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Fayetteville, North Carolina, Forente stater, 28304
- Coastal Research Institute - Fayetteville ( Site 0159)
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Morehead City, North Carolina, Forente stater, 28557
- Lucas Research, Inc ( Site 0105)
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Texas
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Arlington, Texas, Forente stater, 76012
- Texas Clinical Research Institute ( Site 0126)
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Austin, Texas, Forente stater, 78757
- Pinnacle Clinical Research ( Site 0104)
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Corpus Christi, Texas, Forente stater, 78404
- Pinnacle Clinical Research-Corpus Christi ( Site 0156)
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Dallas, Texas, Forente stater, 75230
- Zenos Clinical Research ( Site 0136)
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Fort Worth, Texas, Forente stater, 76104
- GI Alliance Department of Research ( Site 0162)
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Houston, Texas, Forente stater, 77079
- Houston Research Institute ( Site 0117)
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Houston, Texas, Forente stater, 77004
- Houston Research Institute ( Site 0172)
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San Antonio, Texas, Forente stater, 78215
- American Research Corporation ( Site 0131)
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San Antonio, Texas, Forente stater, 78229
- Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125)
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Virginia
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Charlottesville, Virginia, Forente stater, 22908
- University of Virginia Health System ( Site 0164)
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Frankrike, 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, Frankrike, 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, Frankrike, 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, Frankrike, 92110
- Hôpital Beaujon-Hépatologie ( Site 0703)
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Limousin
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Limoges, Limousin, Frankrike, 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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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, Spania, 08035
- Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1002)
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Madrid, Spania, 28046
- Hospital Universitario La Paz-HEPATOLOGIA ( Site 1005)
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Seville, Spania, 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, Spania, 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, Spania, 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, Spania, 13700
- Hospital General de Tomelloso-Aparato Digestivo ( Site 1006)
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La Coruna
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A Coruña, La Coruna, Spania, 15006
- CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 1007)
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Santiago de Compostela, La Coruna, Spania, 15706
- CHUS - Hospital Clinico Universitario ( Site 1011)
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London, City of
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London, London, City of, Storbritannia, SE5 9RL
- King's College Hospital ( Site 1104)
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Scotland
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Aberdeen, Scotland, Storbritannia, AB25 2ZN
- Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 1102)
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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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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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
Andre navn:
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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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in Liver Fat Content (LFC) at Week 28
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in Iron-corrected T1 (cT1) at Week 28
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 6024-017
- MK-6024-017 (Annen identifikator: MSD)
- jRCT2031240217 (Registeridentifikator: jRCT)
- U1111-1302-7589 (Registeridentifikator: UTN)
- 2024-510923-20-00 (Registeridentifikator: EU CT)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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