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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-510923-20-00 | Registry Identifier | EU CT | |
| MK-6024-017 | Other Identifier | MSD | |
| jRCT2031240217 | Registry Identifier | jRCT | |
| U1111-1302-7589 | Registry Identifier | UTN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efinopegdutide | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efinopegdutide | Combination Product | Efinopegdutide is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Liver Fat Content (LFC) at Week 28 | 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 |
| Percentage of Participants Who Experienced an Adverse Event (AE) | An AE is a health problem that happens or worsens during the study | Up to approximately 36 weeks |
| Percentage of Participants Discontinuing Study Medication Due to an AE | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Iron-corrected T1 (cT1) at Week 28 | 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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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149) | Chandler | Arizona | 85224 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| Placebo | Combination Product | Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks. |
|
| Change from Baseline in Enhanced Liver Fibrosis (ELF) score at Week 28 | 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 |
| Change from Baseline in Propeptide of Type III Collagen (Pro-C3) at Week 28 | 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 | 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 |
| Change from Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) at week 28 | 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 |
| Percent Change from Baseline in Body Weight at Week 28 | 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 |
| Arizona Clinical Trials ( Site 0158) | Flagstaff | Arizona | 86001 | United States |
| The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120) | Peoria | Arizona | 85381 | United States |
| The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 0111) | Tucson | Arizona | 85712 | United States |
| California Liver Research Institute ( Site 0113) | Pasadena | California | 91105 | United States |
| Acclaim Clinical Research ( Site 0137) | San Diego | California | 92120 | United States |
| Velocity Clinical Research, Panorama City ( Site 0124) | Van Nuys | California | 91405 | United States |
| Rocky Mountain Gastroenterology ( Site 0127) | Littleton | Colorado | 80120 | United States |
| Synergy Healthcare ( Site 0118) | Bradenton | Florida | 34209 | United States |
| Homestead Associates in Research, Inc. ( Site 0139) | Homestead | Florida | 33033 | United States |
| Florida Research Institute ( Site 0116) | Lakewood Rch | Florida | 34211 | United States |
| Floridian Clinical Research, LLC ( Site 0109) | Miami Lakes | Florida | 33016 | United States |
| Southeast Clinical Research Center ( Site 0119) | Dalton | Georgia | 30720 | United States |
| Delta Research Partners ( Site 0160) | Bastrop | Louisiana | 71220 | United States |
| Louisiana Research Center ( Site 0161) | Shreveport | Louisiana | 71105 | United States |
| Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130) | Glen Burnie | Maryland | 21061 | United States |
| Velocity Clinical Research Rockville ( Site 0143) | Rockville | Maryland | 20854 | United States |
| Huron Gastroenterology ( Site 0102) | Ypsilanti | Michigan | 48197 | United States |
| The Machuca Foundation ( Site 0115) | Las Vegas | Nevada | 89101 | United States |
| Excel Clinical Research, LLC ( Site 0101) | Las Vegas | Nevada | 89109 | United States |
| Southwest Gastroenterology Associates ( Site 0129) | Albuquerque | New Mexico | 87109 | United States |
| Coastal Research Institute - Fayetteville ( Site 0159) | Fayetteville | North Carolina | 28304 | United States |
| Lucas Research, Inc ( Site 0105) | Morehead City | North Carolina | 28557 | United States |
| Texas Clinical Research Institute ( Site 0126) | Arlington | Texas | 76012 | United States |
| Pinnacle Clinical Research ( Site 0104) | Austin | Texas | 78757 | United States |
| Pinnacle Clinical Research-Corpus Christi ( Site 0156) | Corpus Christi | Texas | 78404 | United States |
| Zenos Clinical Research ( Site 0136) | Dallas | Texas | 75230 | United States |
| GI Alliance Department of Research ( Site 0162) | Fort Worth | Texas | 76104 | United States |
| Houston Research Institute ( Site 0172) | Houston | Texas | 77004 | United States |
| Houston Research Institute ( Site 0117) | Houston | Texas | 77079 | United States |
| American Research Corporation ( Site 0131) | San Antonio | Texas | 78215 | United States |
| Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125) | San Antonio | Texas | 78229 | United States |
| University of Virginia Health System ( Site 0164) | Charlottesville | Virginia | 22908 | United States |
| Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202) | Adelaide | South Australia | 5042 | Australia |
| St Vincent's Hospital-Gastroenterology Department ( Site 1205) | Melbourne | Victoria | 3065 | Australia |
| Toronto General Hospital ( Site 0207) | Toronto | Ontario | M5G 2C4 | Canada |
| Diex Recherche Quebec ( Site 0204) | Québec | Quebec | G1V 4T3 | Canada |
| Fundacion Santa Fe de Bogota ( Site 0403) | Bogotá | Cundinamarca | 110111 | Colombia |
| Fundación Valle del Lili ( Site 0402) | Cali | Valle del Cauca Department | 760032 | Colombia |
| Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol ( Site 0704) | Nice | Alpes-Maritimes | 06202 | France |
| CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0701) | Pessac | Aquitaine | 33600 | France |
| Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0705) | Lyon | Auvergne-Rhône-Alpes | 69004 | France |
| Hôpital Beaujon-Hépatologie ( Site 0703) | Clichy | Hauts-de-Seine | 92110 | France |
| Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-Hépato-gastroentérologie ( Site 0702) | Limoges | Limousin | 87042 | France |
| Rambam Health Care Campus ( Site 0801) | Haifa | 3109601 | Israel |
| Carmel Hospital-Liver Unit ( Site 0802) | Haifa | 3436212 | Israel |
| Shaare Zedek Medical Center ( Site 0805) | Jerusalem | 9103102 | Israel |
| Maccabi Health Services - Petah Tikva ( Site 0804) | Petah Tikva | 4925110 | Israel |
| Assuta Medical Center ( Site 0806) | Tel Aviv | 6789140 | Israel |
| Shinyurigaoka General Hospital ( Site 1401) | Kawasaki | Kanagawa | 215-0026 | Japan |
| Yokohama City University Hospital ( Site 1402) | Yokohama | Kanagawa | 236-0004 | Japan |
| University Hospital,Kyoto Prefectural University of Medicine ( Site 1404) | Kyoto | 602-8566 | Japan |
| Osaka Metropolitan University Hospital ( Site 1403) | Osaka | 545-8586 | Japan |
| Saga University Hospital ( Site 1405) | Saga | 849-8501 | Japan |
| ISIS CLINICAL RESEARCH CENTER ( Site 0606) | Guaynabo | 00968 | Puerto Rico |
| Klinical Investigations Group-Clinical Research ( Site 0601) | San Juan | 00909 | Puerto Rico |
| Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 1004) | Santander | Cantabria | 39005 | Spain |
| Hospital Clínico Universitario de Valladolid-Servicio de Endocrinologia y Nutricion ( Site 1008) | Valladolid | Castille and León | 47010 | Spain |
| Hospital General de Tomelloso-Aparato Digestivo ( Site 1006) | Tomelloso | Ciudad Real | 13700 | Spain |
| CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 1007) | A Coruña | La Coruna | 15006 | Spain |
| CHUS - Hospital Clinico Universitario ( Site 1011) | Santiago de Compostela | La Coruna | 15706 | Spain |
| Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1002) | Barcelona | 08035 | Spain |
| Hospital Universitario La Paz-HEPATOLOGIA ( Site 1005) | Madrid | 28046 | Spain |
| HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos clinicos de Aparato Digestivo ( Site 1001) | Seville | 41013 | Spain |
| Chulalongkorn University ( Site 1301) | Bangkok | Bangkok | 10330 | Thailand |
| Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 1302) | Bangkok | Bangkok | 10700 | Thailand |
| King's College Hospital ( Site 1104) | London | London, City of | SE5 9RL | United Kingdom |
| Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 1102) | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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