Non-alcoholic Fatty Liver Disease Clinical Trial
Official title:
A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Precirrhotic Nonalcoholic Steatohepatitis
The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH). Researchers will also learn about the safety and benefit of efinopegdutide and how well people tolerate the medicine. The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | December 5, 2025 |
| Est. primary completion date | December 5, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) =4 with a score =1 point in each component (steatosis, ballooning, and lobular inflammation) AND NASH clinical research network (CRN) fibrosis score of Stage 2 or 3 - No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM with an A1C =9% that is controlled by diet or stable doses of antihyperglycemic agents (AHAs) - Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive) Exclusion Criteria: - History of liver disease other than NASH - History or evidence of cirrhosis - History of pancreatitis - History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy - History of a bariatric surgical procedure =5 years before study entry, or a known clinically significant gastric emptying abnormality - Has significant systemic or major illnesses, including recent events (=6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medizinische Universität Graz-Department of Internal Medicine ( Site 0302) | Graz | Steiermark |
| Belgium | Antwerp University Hospital-Gastr-enterologie/hepatologie ( Site 3300) | Edegem | Antwerpen |
| Belgium | AZ Maria Middelares-Digestief Centrum ( Site 3301) | Gent | Oost-Vlaanderen |
| Belgium | UZ Leuven-Hepatology ( Site 3302) | Leuven | Vlaams-Brabant |
| Canada | Heritage Medical Research Clinic ( Site 0403) | Calgary | Alberta |
| Canada | McGill University Health Centre ( Site 0400) | Montréal | Quebec |
| Canada | Diex Recherche Quebec Inc. ( Site 0409) | Quebec | |
| Canada | Toronto General Hospital ( Site 0402) | Toronto | Ontario |
| Canada | Vancouver General Hospital-Gastroenterology ( Site 0408) | Vancouver | British Columbia |
| Chile | Enroll SpA ( Site 0501) | Providencia | Region M. De Santiago |
| Chile | CECIM ( Site 0500) | Santiago | Region M. De Santiago |
| Chile | Pontificia Universidad Catolica de Chile-CICUC ( Site 0502) | Santiago | Region M. De Santiago |
| China | Beijing Tsinghua Changgung Hospital ( Site 0606) | Beijing | Beijing |
| China | Beijing Youan Hospital ( Site 0602) | Beijing | Beijing |
| China | West China Hospital, Sichuan University ( Site 0611) | Cheng Du | Sichuan |
| China | Chongqing University Three Gorges Hospital ( Site 0607) | Chongqing | Chongqing |
| China | Southern Medical University Nanfang Hospital ( Site 0601) | Guangzhou | Guangdong |
| China | The First Affiliated Hospital, Sun Yat-sen University ( Site 0603) | Guangzhou | Guangdong |
| China | No. 2 Hospital of Nanjing ( Site 0605) | Nanjing | Jiangsu |
| China | The First Affiliated Hospital of Wenzhou Medical University ( Site 0609) | Wenzhou | Zhejiang |
| Colombia | Fundacion Santa Fe de Bogota ( Site 0701) | Bogotá | Cundinamarca |
| Colombia | Solano & Terront Servicios Medicos - UNIENDO ( Site 0705) | Bogotá | Cundinamarca |
| Colombia | Fundación Valle del Lili ( Site 0700) | Cali | Valle Del Cauca |
| Colombia | Fundación Centro de Investigación Clínica CIC ( Site 0704) | Medellín | Antioquia |
| Colombia | Oncomédica S.A.S ( Site 0702) | Montería | Cordoba |
| Colombia | Sociedad De Oncología y Hematología Del Cesar SAS ( Site 0708) | Valledupar | Cesar |
| Czechia | Krajská nemocnice Liberec ( Site 0800) | Liberec | |
| Czechia | KlinMed ( Site 0801) | Prague | Praha 2 |
| Czechia | Vseobecna fakultni nemocnice v Praze ( Site 0802) | Praha 2 | |
| France | Centre Hospitalier Universitaire d'Angers-Hepato Gastroenterology ( Site 0900) | Angers | Maine-et-Loire |
| France | Centre Hospitalier Universitaire Estaing ( Site 0913) | Clermont-Ferrand | Puy-de-Dome |
| France | Hôpital Beaujon-Hépatologie ( Site 0908) | Clichy | Hauts-de-Seine |
| France | Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0911) | Lyon | Rhone-Alpes |
| France | Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol | Nice | Alpes-Maritimes |
| France | Hôpital Saint Antoine ( Site 0914) | Paris | |
| France | Hopitaux Universitaires Paris Centre-Hopital Cochin-Service HEPATOLOGIE- Recherche Clinique ( Site 0 | Paris | |
| France | CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0904) | Pessac | Aquitaine |
| France | centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0906) | Pierre-Bénite | Rhone-Alpes |
| France | CHU Charles Nicolle ( Site 0910) | Rouen | Haute-Normandie |
| Hong Kong | Prince of Wales Hospital ( Site 1000) | Shatin | |
| Hungary | SYNEXUS Magyarország Kft. Eü. ( Site 1110) | Budapest | |
| Israel | Carmel Hospital ( Site 1305) | Haifa | |
| Israel | Rambam Health Care Campus ( Site 1304) | Haifa | |
| Israel | Shaare Zedek Medical Center-Liver Unit ( Site 1302) | Jerusalem | |
| Israel | Rabin Medical Center ( Site 1301) | Petah Tikva | |
| Israel | Sheba Medical Center ( Site 1300) | Ramat Gan | |
| Israel | Maccabi Health Services - Ramat Hasharon ( Site 1303) | Ramat Hasharon | |
| Italy | Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 1403) | Milano | Lombardia |
| Italy | A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic ( Site 1402) | Palermo | Sicilia |
| Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Dipartimento di Medicina Interna e Gas | Roma | Lazio |
| Italy | Humanitas-Medicina interna ed Epatologia ( Site 1400) | Rozzano | Lombardia |
| Italy | Azienda Ospedaliero-Universitaria Città della Salute e della-S.C. Gastroenterologia U. ( Site 1401) | Torino | |
| Japan | Fukuiken Saiseikai Hospital ( Site 1507) | Fukui | |
| Japan | Gifu Municipal Hospital ( Site 1506) | Gifu | |
| Japan | Nara Medical University Hospital ( Site 1513) | Kashihara | Nara |
| Japan | Shinyurigaoka General Hospital ( Site 1518) | Kawasaki | Kanagawa |
| Japan | St. Marianna University Hospital ( Site 1516) | Kawasaki | Kanagawa |
| Japan | Toranomon Hospital Kajigaya ( Site 1502) | Kawasaki | Kanagawa |
| Japan | Kagawa University Hospital ( Site 1515) | Kita | Kagawa |
| Japan | Kurume University Hospital ( Site 1504) | Kurume | Fukuoka |
| Japan | University Hospital,Kyoto Prefectural University of Medicine ( Site 1519) | Kyoto | |
| Japan | Shinshu University Hospital ( Site 1512) | Matsumoto | Nagano |
| Japan | Toranomon Hospital ( Site 1501) | Minato-ku | Tokyo |
| Japan | Ogaki Municipal Hospital ( Site 1511) | Ogaki | Gifu |
| Japan | Kawasaki Medical School General Medical Center ( Site 1508) | Okayama | |
| Japan | Osaka Metropolitan University Hospital ( Site 1520) | Osaka | |
| Japan | Saga University Hospital ( Site 1510) | Saga | |
| Japan | Sapporo Kosei General Hospital ( Site 1521) | Sapporo | Hokkaido |
| Japan | Osaka Saiseikai Suita Hospital ( Site 1503) | Suita | Osaka |
| Japan | Kagawa Prefectural Central Hospital ( Site 1514) | Takamatsu | Kagawa |
| Japan | Japanese Red Cross Musashino Hospital ( Site 1517) | Tokyo | |
| Japan | Ehime University Hospital ( Site 1509) | Toon | Ehime |
| Japan | Yokohama City University Hospital ( Site 1505) | Yokohama | Kanagawa |
| Korea, Republic of | Boramae Medical Center-Internal Medicine ( Site 2403) | Dongjak-gu | Seoul |
| Korea, Republic of | Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2402) | Incheon | |
| Korea, Republic of | Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2400) | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System ( Site 2401) | Seoul | |
| Mexico | Centro de Investigación y Gastroenterología ( Site 1601) | Cuauhtemoc | |
| Mexico | Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 1603) | Mexico City | Distrito Federal |
| Mexico | Centro de Investigacion Clinica de Oaxaca ( Site 1607) | Oaxaca | |
| Peru | CLINICA DELGADO-Clinical Research ( Site 1800) | Miraflores | Lima |
| Peru | Instituto Médico Soy Diabetico ( Site 1804) | Piura | |
| Peru | Centro de investigacion Clínica Trujillo ( Site 1802) | Trujillo | La Libertad |
| Portugal | Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira-Internal Medicine ( Site 1905) | Guimarães | Braga |
| Portugal | Centro Hospitalar de Lisboa Ocidental - Hospital de Egas Moniz ( Site 1906) | Lisbon | Lisboa |
| Portugal | Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 1904) | Lisbon | Lisboa |
| Portugal | ULSAM - Hospital de Santa Luzia ( Site 1907) | Viana do Castelo | |
| Puerto Rico | ISIS CLINICAL RESEARCH CENTER ( Site 2006) | Guaynabo | |
| Puerto Rico | Pan American Center for Oncology Trials ( Site 2000) | Rio Piedras | |
| Puerto Rico | Klinical Investigations Group-Clinical Research ( Site 2001) | San Juan | |
| Puerto Rico | Latin Clinical Trial Center ( Site 2004) | San Juan | |
| Singapore | Singapore General Hospital ( Site 2188) | Singapore | Central Singapore |
| Spain | CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 2511) | A Coruña | La Coruna |
| Spain | Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 2507) | Barcelona | |
| Spain | Hospital Universitario La Paz-HEPATOLOGIA ( Site 2509) | Madrid | |
| Spain | HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Gastroenterologia y Hepatologia ( Site 2500) | Madrid | |
| Spain | Hospital Universitario Ramón y Cajal ( Site 2508) | Madrid | Madrid, Comunidad De |
| Spain | Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 2506) | Malaga | Andalucia |
| Spain | Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2505) | Santander | Cantabria |
| Spain | CHUS - Hospital Clinico Universitario ( Site 2503) | Santiago de Compostela | La Coruna |
| Spain | HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 2504) | Sevilla | |
| Spain | Hospital General de Tomelloso-Aparato Digestivo ( Site 2514) | Tomelloso | Ciudad Real |
| Switzerland | Fondazione Epatocentro Ticino ( Site 2602) | Lugano | Ticino |
| Switzerland | Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 2601) | st.Gallen | Sankt Gallen |
| Switzerland | UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 2603) | Zürich | Zurich |
| Taiwan | Changhua Christian Hospital-Endocrinology and metabolism ( Site 2704) | Changhua County | Changhua |
| Taiwan | Chiayi Christian Hospital ( Site 2707) | Chiayi City | Chiayi |
| Taiwan | Taichung Veterans General Hospital ( Site 2703) | Taichung | |
| Taiwan | National Cheng Kung University Hospital-Liver Research team of National Cheng Kung University Hospi | Tainan | |
| Taiwan | National Taiwan University Hospital-Internal Medicine ( Site 2700) | Taipei | |
| Taiwan | Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine ( | Taipei | |
| Taiwan | Chang Gung Medical Foundation-Linkou Branch ( Site 2702) | Taoyuan | |
| Thailand | Chulalongkorn University ( Site 2800) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 2802) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Maharaj Nakorn Chiang Mai Hospital ( Site 2801) | Muang | Chiang Mai |
| Turkey | Hacettepe Universite Hastaneleri-internal diseases ( Site 2901) | Ankara | |
| Turkey | Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2903) | Istanbul | |
| Turkey | Dokuz Eylul Universitesi Hastanesi-Gastroenterology ( Site 2905) | Izmir | |
| Turkey | Recep Tayyip Erdogan University Training and Research Hospital ( Site 2900) | Rize | |
| United Kingdom | Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 3004) | Aberdeen | Scotland |
| United Kingdom | Queen Elizabeth Hospital Birmingham ( Site 3000) | Birmingham | England |
| United Kingdom | King's College Hospital ( Site 3002) | London | London, City Of |
| United Kingdom | Royal London Hospital ( Site 3003) | London | England |
| United States | Synergy Healthcare ( Site 3286) | Bradenton | Florida |
| United States | Synergy Healthcare LLC ( Site 3290) | Brandon | Florida |
| United States | South Texas Research Institute - Brownsville ( Site 3285) | Brownsville | Texas |
| United States | Om Research LLC ( Site 3245) | Camarillo | California |
| United States | The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 3 | Chandler | Arizona |
| United States | Eagle Clinical Research ( Site 3233) | Chicago | Illinois |
| United States | Velocity Clinical Research, Cincinnati ( Site 3237) | Cincinnati | Ohio |
| United States | Top Medical Research ( Site 3209) | Cutler Bay | Florida |
| United States | Velocity Clinical Research, Dallas ( Site 3220) | Dallas | Texas |
| United States | Southeast Clinical Research Center ( Site 3288) | Dalton | Georgia |
| United States | Velocity Clinical Research, Providence ( Site 3222) | East Greenwich | Rhode Island |
| United States | Velocity Clinical Research, Syracuse ( Site 3227) | East Syracuse | New York |
| United States | Covenant Metabolic Specialists, LLC ( Site 3231) | Fort Myers | Florida |
| United States | Velocity Clinical Research, Gardena ( Site 3225) | Gardena | California |
| United States | Velocity Clinical Research, Hallandale Beach ( Site 3241) | Hallandale Beach | Florida |
| United States | Indago Research & Health Center, Inc ( Site 3207) | Hialeah | Florida |
| United States | Sweet Hope Research Specialty, Inc-Research ( Site 3200) | Hialeah | Florida |
| United States | Houston Research Institute ( Site 3262) | Houston | Texas |
| United States | Velocity Clinical Research, Huntington Park ( Site 3217) | Huntington Park | California |
| United States | University of Iowa ( Site 3213) | Iowa City | Iowa |
| United States | Kansas City Research Institute ( Site 3249) | Kansas City | Missouri |
| United States | Velocity Clinical Research, San Diego ( Site 3226) | La Mesa | California |
| United States | Florida Research Institute ( Site 3243) | Lakewood Ranch | Florida |
| United States | Om Research LLC ( Site 3229) | Lancaster | California |
| United States | The Machuca Foundation ( Site 3234) | Las Vegas | Nevada |
| United States | Velocity Clinical Research, Westlake ( Site 3216) | Los Angeles | California |
| United States | Genoma Research Group ( Site 3242) | Miami | Florida |
| United States | Floridian Clinical Research, LLC ( Site 3203) | Miami Lakes | Florida |
| United States | New York Gastroenterology Associates ( Site 3252) | New York | New York |
| United States | Velocity Clinical Research, Panorama City ( Site 3214) | Panorama City | California |
| United States | California Liver Research Institute ( Site 3232) | Pasadena | California |
| United States | The Institute for Liver Health II dba Arizona Clinical Trials - Peoria ( Site 3289) | Peoria | Arizona |
| United States | Gastroenterology Consultants of Southwest Virginia ( Site 3282) | Roanoke | Virginia |
| United States | Clinical Trials Research ( Site 3230) | Sacramento | California |
| United States | American Research Corporation ( Site 3202) | San Antonio | Texas |
| United States | Pinnacle Clinical Research ( Site 3284) | San Antonio | Texas |
| United States | Del Sol Research Management, LLC ( Site 3211) | Tucson | Arizona |
| United States | The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 3218) | Tucson | Arizona |
| United States | Velocity Clinical Research, Salt Lake City ( Site 3223) | West Jordan | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Austria, Belgium, Canada, Chile, China, Colombia, Czechia, France, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Peru, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52 | The NASH Clinical Research Network (CRN) scoring system evaluated by Blinded Independent Central Review (BICR) is used to assess treatment response. The NASH CRN scoring scales are: lobular inflammation score (0-3); hepatocyte ballooning score (0-2); steatosis score (0-3); and fibrosis score (0-4). NASH resolution is defined as a score of 0-1 for inflammation, 0 for ballooning, and any grade of steatosis. | Week 52 | |
| Primary | Percentage of Participants Who Experienced an Adverse Event (AE) | An adverse event (AE) is a health problem that happens or worsens during a study. | Up to 60 weeks | |
| Primary | Percentage of Participants Discontinuing Study Medication Due to an AE | An adverse event (AE) is a health problem that happens or worsens during a study. | Up to 52 weeks | |
| Secondary | Percentage of Participants With =1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis At Week 52 | Participants will be assessed using the NASH CRN scoring system evaluated by BICR for =1-stage improvement in fibrosis without worsening of steatohepatitis. Fibrosis is scored from stage 0 to 4 where 0 = None, 1=Perisinusoidal OR periportal, 2=Perisinusoidal AND portal/periportal, 3= Bridging fibrosis, 4=Cirrhosis. No worsening of steatohepatitis is defined as no increase in the ballooning, inflammation, or steatosis scores. | Week 52 | |
| Secondary | Change from Baseline in Body Weight At Week 52 | Body weight (kg) will be measured using a standardized, digital scale. The percent change from baseline in body weight after 52 weeks will be reported. | Week 52 |
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