Clinical trial NCT05877547: A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-alcoholic Fatty Liver Disease
Fatty Liver, Nonalcoholic
NAFLD
Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-05-26
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52
timeFrame: Week 52
measure: Percentage of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to 60 weeks
measure: Percentage of Participants Discontinuing Study Medication Due to an AE
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis At Week 52
timeFrame: Week 52
measure: Change from Baseline in Body Weight At Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Chandler
country: United States
facility: The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 3
state: Arizona
city: Peoria
country: United States
facility: The Institute for Liver Health II dba Arizona Clinical Trials - Peoria ( Site 3289)
state: Arizona
city: Tucson
country: United States
facility: The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 3218)
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management, LLC ( Site 3211)
state: Arizona
city: Apple Valley
country: United States
facility: Om Research - Apple Valley ( Site 3244)
state: California
city: Camarillo
country: United States
facility: Om Research LLC ( Site 3245)
state: California
city: Gardena
country: United States
facility: Velocity Clinical Research, Gardena ( Site 3225)
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park ( Site 3217)
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research, San Diego ( Site 3226)
state: California
city: Lancaster
country: United States
facility: Om Research LLC ( Site 3229)
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Westlake ( Site 3216)
state: California
city: Panorama City
country: United States
facility: Velocity Clinical Research, Panorama City ( Site 3214)
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute ( Site 3232)
state: California
city: Sacramento
country: United States
facility: Clinical Trials Research ( Site 3230)
state: California
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials ( Site 3246)
state: Florida
city: Bradenton
country: United States
facility: Synergy Healthcare ( Site 3286)
state: Florida
city: Brandon
country: United States
facility: Synergy Healthcare LLC ( Site 3290)
state: Florida
city: Cutler Bay
country: United States
facility: Top Medical Research ( Site 3209)
state: Florida
city: Fort Myers
country: United States
facility: Covenant Metabolic Specialists, LLC ( Site 3231)
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach ( Site 3241)
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc ( Site 3207)
state: Florida
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty, Inc-Research ( Site 3200)
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Research Institute ( Site 3243)
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research, LLC ( Site 3203)
state: Florida
city: Miami
country: United States
facility: Genoma Research Group ( Site 3242)
state: Florida
city: Dalton
country: United States
facility: Southeast Clinical Research Center ( Site 3288)
state: Georgia
city: Chicago
country: United States
facility: Eagle Clinical Research ( Site 3233)
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa ( Site 3213)
state: Iowa
city: Kansas City
country: United States
facility: Kansas City Research Institute ( Site 3249)
state: Missouri
city: Las Vegas
country: United States
facility: The Machuca Foundation ( Site 3234)
state: Nevada
city: East Syracuse
country: United States
facility: Velocity Clinical Research, Syracuse ( Site 3227)
state: New York
city: New York
country: United States
facility: New York Gastroenterology Associates ( Site 3252)
state: New York
city: Cincinnati
country: United States
facility: Velocity Clinical Research, Cincinnati ( Site 3237)
state: Ohio
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence ( Site 3222)
state: Rhode Island
city: Austin
country: United States
facility: Velocity Clinical Research, Austin ( Site 3235)
state: Texas
city: Brownsville
country: United States
facility: South Texas Research Institute - Brownsville ( Site 3285)
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas ( Site 3220)
state: Texas
city: Houston
country: United States
facility: Houston Research Institute ( Site 3262)
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation ( Site 3202)
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research ( Site 3284)
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City ( Site 3223)
state: Utah
city: Roanoke
country: United States
facility: Gastroenterology Consultants of Southwest Virginia ( Site 3282)
state: Virginia
city: Graz
country: Austria
facility: Medizinische Universität Graz-Department of Internal Medicine ( Site 0302)
state: Steiermark
city: Edegem
country: Belgium
facility: Antwerp University Hospital-Gastr-enterologie/hepatologie ( Site 3300)
state: Antwerpen
city: Gent
country: Belgium
facility: AZ Maria Middelares-Digestief Centrum ( Site 3301)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven-Hepatology ( Site 3302)
state: Vlaams-Brabant
city: Calgary
country: Canada
facility: Heritage Medical Research Clinic ( Site 0403)
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital-Gastroenterology ( Site 0408)
state: British Columbia
city: Toronto
country: Canada
facility: Toronto General Hospital ( Site 0402)
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0400)
state: Quebec
city: Quebec
country: Canada
facility: Diex Recherche Quebec Inc. ( Site 0409)
city: Providencia
country: Chile
facility: Enroll SpA ( Site 0501)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: CECIM ( Site 0500)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-CICUC ( Site 0502)
state: Region M. De Santiago
city: Beijing
country: China
facility: Beijing Youan Hospital ( Site 0602)
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital ( Site 0606)
state: Beijing
city: Wanzhou
country: China
facility: Chongqing University Three Gorges Hospital ( Site 0607)
state: Chongqing
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University ( Site 0603)
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital ( Site 0601)
state: Guangdong
city: Nanjing
country: China
facility: No. 2 Hospital of Nanjing ( Site 0605)
state: Jiangsu
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University ( Site 0611)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Second People's Hospital ( Site 0604)
state: Tianjin
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University ( Site 0609)
state: Zhejiang
city: Medellín
country: Colombia
facility: Fundación Centro de Investigación Clínica CIC ( Site 0704)
state: Antioquia
city: Valledupar
country: Colombia
facility: Sociedad De Oncología y Hematología Del Cesar SAS ( Site 0708)
state: Cesar
city: Montería
country: Colombia
facility: Oncomédica S.A.S ( Site 0702)
state: Cordoba
city: Bogotá
country: Colombia
facility: Fundacion Santa Fe de Bogota ( Site 0701)
state: Cundinamarca
city: Bogotá
country: Colombia
facility: Solano & Terront Servicios Medicos - UNIENDO ( Site 0705)
state: Cundinamarca
city: Cali
country: Colombia
facility: Fundación Valle del Lili ( Site 0700)
state: Valle Del Cauca
city: Prague
country: Czechia
facility: KlinMed ( Site 0801)
state: Praha 2
city: Liberec
country: Czechia
facility: Krajská nemocnice Liberec ( Site 0800)
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze ( Site 0802)
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol
state: Alpes-Maritimes
city: Pessac
country: France
facility: CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0904)
state: Aquitaine
city: Rouen
country: France
facility: CHU Charles Nicolle ( Site 0910)
state: Haute-Normandie
city: Clichy
country: France
facility: Hôpital Beaujon-Hépatologie ( Site 0908)
state: Hauts-de-Seine
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers-Hepato Gastroenterology ( Site 0900)
state: Maine-et-Loire
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire Estaing ( Site 0913)
state: Puy-de-Dome
city: Lyon
country: France
facility: Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0911)
state: Rhone-Alpes
city: Pierre-Bénite
country: France
facility: centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0906)
state: Rhone-Alpes
city: Paris
country: France
facility: Hôpital Saint Antoine ( Site 0914)
city: Paris
country: France
facility: Hopitaux Universitaires Paris Centre-Hopital Cochin-Service HEPATOLOGIE- Recherche Clinique ( Site 0
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital ( Site 1000)
city: Budapest
country: Hungary
facility: SYNEXUS Magyarország Kft. Eü. ( Site 1110)
city: Budapest
country: Hungary
facility: Dél-Pesti Centrumkórház-Hepatologiai Szakrendekő ( Site 1102)
city: Ashkelon
country: Israel
facility: Barzilai Medical Center ( Site 1306)
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 1304)
city: Haifa
country: Israel
facility: Carmel Hospital ( Site 1305)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center-Liver Unit ( Site 1302)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1301)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 1300)
city: Ramat Hasharon
country: Israel
facility: Maccabi Health Services - Ramat Hasharon ( Site 1303)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Dipartimento di Medicina Interna e Gas
state: Lazio
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 1403)
state: Lombardia
city: Rozzano
country: Italy
facility: Humanitas-Medicina interna ed Epatologia ( Site 1400)
state: Lombardia
city: Palermo
country: Italy
facility: A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic ( Site 1402)
state: Sicilia
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Città della Salute e della-S.C. Gastroenterologia U. ( Site 1401)
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 1509)
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 1504)
state: Fukuoka
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital ( Site 1511)
state: Gifu
city: Sapporo
country: Japan
facility: Sapporo Kosei General Hospital ( Site 1521)
state: Hokkaido
city: Kita
country: Japan
facility: Kagawa University Hospital ( Site 1515)
state: Kagawa
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital ( Site 1514)
state: Kagawa
city: Kawasaki
country: Japan
facility: Toranomon Hospital Kajigaya ( Site 1502)
state: Kanagawa
city: Kawasaki
country: Japan
facility: Shinyurigaoka General Hospital ( Site 1518)
state: Kanagawa
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital ( Site 1516)
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital ( Site 1505)
state: Kanagawa
city: Matsumoto
country: Japan
facility: Shinshu University Hospital ( Site 1512)
state: Nagano
city: Kashihara
country: Japan
facility: Nara Medical University Hospital ( Site 1513)
state: Nara
city: Suita
country: Japan
facility: Osaka Saiseikai Suita Hospital ( Site 1503)
state: Osaka
city: Minato-ku
country: Japan
facility: Toranomon Hospital ( Site 1501)
state: Tokyo
city: Fukui
country: Japan
facility: Fukuiken Saiseikai Hospital ( Site 1507)
city: Gifu
country: Japan
facility: Gifu Municipal Hospital ( Site 1506)
city: Kyoto
country: Japan
facility: University Hospital,Kyoto Prefectural University of Medicine ( Site 1519)
city: Okayama
country: Japan
facility: Kawasaki Medical School General Medical Center ( Site 1508)
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital ( Site 1520)
city: Saga
country: Japan
facility: Saga University Hospital ( Site 1510)
city: Tokyo
country: Japan
facility: Japanese Red Cross Musashino Hospital ( Site 1517)
city: Dongjak-gu
country: Korea, Republic of
facility: Boramae Medical Center-Internal Medicine ( Site 2403)
state: Seoul
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2402)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System ( Site 2401)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2400)
city: Mexico City
country: Mexico
facility: Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 1603)
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 1604)
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Servicios de Oncología Médica Integral - Monterrey ( Site 1611)
state: Nuevo Leon
city: Chihuahua
country: Mexico
facility: ICARO Investigaciones en Medicina ( Site 1608)
city: Cuauhtemoc
country: Mexico
facility: Centro de Investigación y Gastroenterología ( Site 1601)
city: Mexico City
country: Mexico
facility: Centro de Investigación y Gastroenterología - S.C. ( Site 1609)
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization ( Site 1613)
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca ( Site 1607)
city: Trujillo
country: Peru
facility: Centro de investigacion Clínica Trujillo ( Site 1802)
state: La Libertad
city: Miraflores
country: Peru
facility: CLINICA DELGADO-Clinical Research ( Site 1800)
state: Lima
city: Piura
country: Peru
facility: Instituto Médico Soy Diabetico ( Site 1804)
city: Guimaraes
country: Portugal
facility: Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira ( Site 1905)
state: Braga
city: Lisbon
country: Portugal
facility: Unidade Local de Saude Lisboa Ocidental - Hospital Egas Moniz ( Site 1906)
state: Lisboa
city: Lisbon
country: Portugal
facility: Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1904)
state: Lisboa
city: Viana do Castelo
country: Portugal
facility: ULSAM - Hospital de Santa Luzia ( Site 1907)
city: Guaynabo
country: Puerto Rico
facility: ISIS CLINICAL RESEARCH CENTER ( Site 2006)
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials ( Site 2000)
city: San Juan
country: Puerto Rico
facility: Klinical Investigations Group-Clinical Research ( Site 2001)
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center ( Site 2004)
city: Singapore
country: Singapore
facility: Singapore General Hospital ( Site 2188)
state: Central Singapore
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 2506)
state: Andalucia
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2505)
state: Cantabria
city: Tomelloso
country: Spain
facility: Hospital General de Tomelloso-Aparato Digestivo ( Site 2514)
state: Ciudad Real
city: A Coruña
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 2511)
state: La Coruna
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario ( Site 2503)
state: La Coruna
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal ( Site 2508)
state: Madrid, Comunidad De
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 2507)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz-HEPATOLOGIA ( Site 2509)
city: Madrid
country: Spain
facility: HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Gastroenterologia y Hepatologia ( Site 2500)
city: Sevilla
country: Spain
facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 2504)
city: St.Gallen
country: Switzerland
facility: Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 2601)
state: Sankt Gallen
city: Lugano
country: Switzerland
facility: Fondazione Epatocentro Ticino ( Site 2602)
state: Ticino
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 2603)
state: Zurich
city: Changhua County
country: Taiwan
facility: Changhua Christian Hospital-Endocrinology and metabolism ( Site 2704)
state: Changhua
city: Chiayi City
country: Taiwan
facility: Chiayi Christian Hospital ( Site 2707)
state: Chiayi
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 2703)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital-Liver Research team of National Cheng Kung University Hospi
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital-Internal Medicine ( Site 2700)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch ( Site 2702)
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 2801)
state: Chiang Mai
city: Bangkok
country: Thailand
facility: Chulalongkorn University ( Site 2800)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 2802)
state: Krung Thep Maha Nakhon
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-internal diseases ( Site 2901)
city: Istanbul
country: Turkey
facility: Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2903)
city: Istanbul
country: Turkey
facility: T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik -T.C. Sağlik Bakanliği- Marmara Ünivers
city: İzmir
country: Turkey
facility: Dokuz Eylul Universitesi Hastanesi-Gastroenterology ( Site 2905)
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Training and Research Hospital ( Site 2900)
city: London
country: United Kingdom
facility: Royal London Hospital ( Site 3003)
state: England
city: London
country: United Kingdom
facility: King's College Hospital ( Site 3002)
state: London, City Of
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 3004)
state: Scotland
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham ( Site 3000)
state: Warwickshire
city: Leeds
country: United Kingdom
facility: St James's University Hospital ( Site 3005)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: