Phase
Condition
Hypertriglyceridemia
Liver Disease
Liver Disorders
Treatment
Semaglutide
Placebo
Efinopegdutide
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) ≥4 with ascore ≥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
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 diabetessecondary to pancreatectomy
History of a bariatric surgical procedure ≤5 years before study entry, or a knownclinically significant gastric emptying abnormality
Has significant systemic or major illnesses, including recent events (≤6 monthsbefore study entry) of congestive heart failure, unstable angina, myocardialinfarction, arterial revascularization, stroke, or transient ischemic attack
Study Design
Connect with a study center
Medizinische Universität Graz-Department of Internal Medicine ( Site 0302)
Graz, Steiermark 8036
AustriaSite Not Available
Antwerp University Hospital-Gastr-enterologie/hepatologie ( Site 3300)
Edegem, Antwerpen 2650
BelgiumSite Not Available
AZ Maria Middelares-Digestief Centrum ( Site 3301)
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
UZ Leuven-Hepatology ( Site 3302)
Leuven, Vlaams-Brabant 3001
BelgiumSite Not Available
Heritage Medical Research Clinic ( Site 0403)
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
Vancouver General Hospital-Gastroenterology ( Site 0408)
Vancouver, British Columbia V5Z 1M9
CanadaSite Not Available
Toronto General Hospital ( Site 0402)
Toronto, Ontario M5G 2C4
CanadaSite Not Available
McGill University Health Centre ( Site 0400)
Montréal, Quebec H4A 3J1
CanadaSite Not Available
Diex Recherche Quebec Inc. ( Site 0409)
Quebec, G1V 4T3
CanadaSite Not Available
Enroll SpA ( Site 0501)
Providencia, Region M. De Santiago 7500587
ChileSite Not Available
CECIM ( Site 0500)
Santiago, Region M. De Santiago 8320000
ChileSite Not Available
Pontificia Universidad Catolica de Chile-CICUC ( Site 0502)
Santiago, Region M. De Santiago 8330032
ChileSite Not Available
Beijing Tsinghua Changgung Hospital ( Site 0606)
Beijing, Beijing 102218
ChinaSite Not Available
Beijing Youan Hospital ( Site 0602)
Beijing, Beijing 100069
ChinaSite Not Available
Chongqing University Three Gorges Hospital ( Site 0607)
Chongqing, Chongqing 404199
ChinaSite Not Available
Chongqing Three Gorges Central Hospital ( Site 0607)
Wanzhou, Chongqing 404199
ChinaActive - Recruiting
Chongqing University Three Gorges Hospital ( Site 0607)
Wanzhou, Chongqing 404000
ChinaSite Not Available
Southern Medical University Nanfang Hospital ( Site 0601)
Guangzhou, Guangdong 510515
ChinaSite Not Available
The First Affiliated Hospital, Sun Yat-sen University ( Site 0603)
Guangzhou, Guangdong 510080
ChinaSite Not Available
No. 2 Hospital of Nanjing ( Site 0605)
Nanjing, Jiangsu 210037
ChinaSite Not Available
West China Hospital, Sichuan University ( Site 0611)
Cheng Du, Sichuan 610041
ChinaSite Not Available
Tianjin Second People's Hospital ( Site 0604)
Tianjin, Tianjin 300192
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University ( Site 0609)
Wenzhou, Zhejiang 325000
ChinaSite Not Available
Fundación Centro de Investigación Clínica CIC ( Site 0704)
Medellín, Antioquia 050021
ColombiaSite Not Available
Sociedad De Oncología y Hematología Del Cesar SAS ( Site 0708)
Valledupar, Cesar 200001
ColombiaSite Not Available
Oncomédica S.A.S ( Site 0702)
Montería, Cordoba 230002
ColombiaSite Not Available
Fundacion Santa Fe de Bogota ( Site 0701)
Bogotá, Cundinamarca 110111
ColombiaSite Not Available
Solano & Terront Servicios Medicos - UNIENDO ( Site 0705)
Bogotá, Cundinamarca 110221
ColombiaSite Not Available
Fundación Valle del Lili ( Site 0700)
Cali, Valle Del Cauca 760026
ColombiaSite Not Available
KlinMed ( Site 0801)
Prague, Praha 2 120 00
CzechiaSite Not Available
Krajská nemocnice Liberec ( Site 0800)
Liberec, 460 63
CzechiaSite Not Available
Vseobecna fakultni nemocnice v Praze ( Site 0802)
Praha 2, 128 08
CzechiaSite Not Available
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol
Nice, Alpes-Maritimes 06202
FranceSite Not Available
CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0904)
Pessac, Aquitaine 33600
FranceSite Not Available
CHU Charles Nicolle ( Site 0910)
Rouen, Haute-Normandie 76000
FranceSite Not Available
Hôpital Beaujon-Hépatologie ( Site 0908)
Clichy, Hauts-de-Seine 92110
FranceSite Not Available
Centre Hospitalier Universitaire d'Angers-Hepato Gastroenterology ( Site 0900)
Angers, Maine-et-Loire 49933
FranceSite Not Available
Centre Hospitalier Universitaire Estaing ( Site 0913)
Clermont-Ferrand, Puy-de-Dome 63100
FranceSite Not Available
Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0911)
Lyon, Rhone-Alpes 69004
FranceSite Not Available
centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0906)
Pierre-Bénite, Rhone-Alpes 69494 Cédex
FranceSite Not Available
Hopitaux Universitaires Paris Centre-Hopital Cochin-Service HEPATOLOGIE- Recherche Clinique ( Site 0
Paris, 75679
FranceSite Not Available
Hôpital Saint Antoine ( Site 0914)
Paris, 75571
FranceSite Not Available
Prince of Wales Hospital ( Site 1000)
Shatin,
Hong KongSite Not Available
Dél-Pesti Centrumkórház-Hepatologiai Szakrendekő ( Site 1102)
Budapest, 1097
HungarySite Not Available
SYNEXUS Magyarország Kft. Eü. ( Site 1110)
Budapest, 1036
HungarySite Not Available
Barzilai Medical Center ( Site 1306)
Ashkelon, 7830604
IsraelSite Not Available
Carmel Hospital ( Site 1305)
Haifa, 3436212
IsraelSite Not Available
Rambam Health Care Campus ( Site 1304)
Haifa, 3109601
IsraelSite Not Available
Shaare Zedek Medical Center-Liver Unit ( Site 1302)
Jerusalem, 9778419
IsraelSite Not Available
Rabin Medical Center ( Site 1301)
Petah Tikva, 4941 492
IsraelSite Not Available
Sheba Medical Center ( Site 1300)
Ramat Gan, 5265601
IsraelSite Not Available
Maccabi Health Services - Ramat Hasharon ( Site 1303)
Ramat Hasharon, 4731001
IsraelSite Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Dipartimento di Medicina Interna e Gas
Roma, Lazio 00168
ItalySite Not Available
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 1403)
Milano, Lombardia 20122
ItalySite Not Available
Humanitas-Medicina interna ed Epatologia ( Site 1400)
Rozzano, Lombardia 20089
ItalySite Not Available
A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic ( Site 1402)
Palermo, Sicilia 90127
ItalySite Not Available
Azienda Ospedaliero-Universitaria Città della Salute e della-S.C. Gastroenterologia U. ( Site 1401)
Torino, 10126
ItalySite Not Available
Ehime University Hospital ( Site 1509)
Toon, Ehime 7910295
JapanSite Not Available
Kurume University Hospital ( Site 1504)
Kurume, Fukuoka 830-0011
JapanSite Not Available
Ogaki Municipal Hospital ( Site 1511)
Ogaki, Gifu 503-0864
JapanSite Not Available
Sapporo Kosei General Hospital ( Site 1521)
Sapporo, Hokkaido 060-0033
JapanSite Not Available
Kagawa University Hospital ( Site 1515)
Kita, Kagawa 761-0701
JapanSite Not Available
Kagawa Prefectural Central Hospital ( Site 1514)
Takamatsu, Kagawa 760-8557
JapanSite Not Available
Shinyurigaoka General Hospital ( Site 1518)
Kawasaki, Kanagawa 215-0026
JapanSite Not Available
St. Marianna University Hospital ( Site 1516)
Kawasaki, Kanagawa 216-8511
JapanSite Not Available
Toranomon Hospital Kajigaya ( Site 1502)
Kawasaki, Kanagawa 105-8470
JapanSite Not Available
Yokohama City University Hospital ( Site 1505)
Yokohama, Kanagawa 236-0004
JapanSite Not Available
Shinshu University Hospital ( Site 1512)
Matsumoto, Nagano 390-8621
JapanSite Not Available
Nara Medical University Hospital ( Site 1513)
Kashihara, Nara 634-0813
JapanSite Not Available
Osaka Saiseikai Suita Hospital ( Site 1503)
Suita, Osaka 564-0013
JapanSite Not Available
Toranomon Hospital ( Site 1501)
Minato-ku, Tokyo 105-8470
JapanSite Not Available
Fukuiken Saiseikai Hospital ( Site 1507)
Fukui, 918-8503
JapanSite Not Available
Gifu Municipal Hospital ( Site 1506)
Gifu, 500-8513
JapanSite Not Available
University Hospital,Kyoto Prefectural University of Medicine ( Site 1519)
Kyoto, 602-8566
JapanSite Not Available
Kawasaki Medical School General Medical Center ( Site 1508)
Okayama, 700-8505
JapanSite Not Available
Osaka Metropolitan University Hospital ( Site 1520)
Osaka, 545-8586
JapanSite Not Available
Saga University Hospital ( Site 1510)
Saga, 849-8501
JapanSite Not Available
Japanese Red Cross Musashino Hospital ( Site 1517)
Tokyo, 180-8610
JapanSite Not Available
Boramae Medical Center-Internal Medicine ( Site 2403)
Dongjak-gu, Seoul 07061
Korea, Republic ofSite Not Available
Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2402)
Incheon, 22332
Korea, Republic ofSite Not Available
Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2400)
Seoul, 06351
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System ( Site 2401)
Seoul, 03722
Korea, Republic ofSite Not Available
Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 1603)
Mexico City, Distrito Federal 14050
MexicoSite Not Available
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 1604)
Monterrey, Nuevo Leon 64460
MexicoSite Not Available
Servicios de Oncología Médica Integral - Monterrey ( Site 1611)
Monterrey, Nuevo Leon 66220
MexicoSite Not Available
ICARO Investigaciones en Medicina ( Site 1608)
Chihuahua, 31000
MexicoSite Not Available
Centro de Investigación y Gastroenterología ( Site 1601)
Cuauhtemoc, 06700
MexicoSite Not Available
Centro de Investigación y Gastroenterología ( Site 1601)
Cuauhtémoc, 06700
MexicoSite Not Available
Centro de Investigación y Gastroenterología - S.C. ( Site 1609)
Mexico City, 03330
MexicoSite Not Available
Centro de Investigacion Clinica de Oaxaca ( Site 1607)
Oaxaca, 68020
MexicoSite Not Available
Oaxaca Site Management Organization ( Site 1613)
Oaxaca, 68000
MexicoSite Not Available
Centro de investigacion Clínica Trujillo ( Site 1802)
Trujillo, La Libertad 13001
PeruSite Not Available
CLINICA DELGADO-Clinical Research ( Site 1800)
Miraflores, Lima 15074
PeruSite Not Available
Instituto Médico Soy Diabetico ( Site 1804)
Piura, 20009
PeruSite Not Available
Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira ( Site 1905)
Guimaraes, Braga 4835-044
PortugalSite Not Available
Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira-Internal Medicine ( Site 1905)
Guimarães, Braga 4800-055
PortugalSite Not Available
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 1904)
Lisbon, Lisboa 1649-035
PortugalActive - Recruiting
Centro Hospitalar de Lisboa Ocidental - Hospital de Egas Moniz ( Site 1906)
Lisbon, Lisboa 1349-019
PortugalActive - Recruiting
Unidade Local de Saude Lisboa Ocidental - Hospital Egas Moniz ( Site 1906)
Lisbon, Lisboa 1349-019
PortugalSite Not Available
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1904)
Lisbon, Lisboa 1649-035
PortugalSite Not Available
ULSAM - Hospital de Santa Luzia ( Site 1907)
Viana do Castelo, 4904 - 858
PortugalSite Not Available
ISIS CLINICAL RESEARCH CENTER ( Site 2006)
Guaynabo, 00968
Puerto RicoSite Not Available
Pan American Center for Oncology Trials ( Site 2000)
Rio Piedras, 00935
Puerto RicoSite Not Available
Klinical Investigations Group-Clinical Research ( Site 2001)
San Juan, 00909
Puerto RicoSite Not Available
Latin Clinical Trial Center ( Site 2004)
San Juan, 00909
Puerto RicoSite Not Available
Singapore General Hospital ( Site 2188)
Singapore, Central Singapore 169608
SingaporeSite Not Available
Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 2506)
Malaga, Andalucia 29010
SpainSite Not Available
Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2505)
Santander, Cantabria 39005
SpainSite Not Available
Hospital General de Tomelloso-Aparato Digestivo ( Site 2514)
Tomelloso, Ciudad Real 13700
SpainSite Not Available
CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 2511)
A Coruña, La Coruna 15006
SpainSite Not Available
CHUS - Hospital Clinico Universitario ( Site 2503)
Santiago de Compostela, La Coruna 15706
SpainSite Not Available
Hospital Universitario Ramón y Cajal ( Site 2508)
Madrid, Madrid, Comunidad De 28034
SpainSite Not Available
Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 2507)
Barcelona, 08035
SpainSite Not Available
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Gastroenterologia y Hepatologia ( Site 2500)
Madrid, 28222
SpainSite Not Available
Hospital Universitario La Paz-HEPATOLOGIA ( Site 2509)
Madrid, 28046
SpainSite Not Available
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 2504)
Sevilla, 41013
SpainSite Not Available
Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 2601)
St.Gallen, Sankt Gallen 9007
SwitzerlandSite Not Available
Fondazione Epatocentro Ticino ( Site 2602)
Lugano, Ticino 6900
SwitzerlandSite Not Available
UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 2603)
Zürich, Zurich 8091
SwitzerlandSite Not Available
Changhua Christian Hospital-Endocrinology and metabolism ( Site 2704)
Changhua County, Changhua 50006
TaiwanSite Not Available
Chiayi Christian Hospital ( Site 2707)
Chiayi City, Chiayi 600
TaiwanSite Not Available
Taichung Veterans General Hospital ( Site 2703)
Taichung, 407
TaiwanSite Not Available
National Cheng Kung University Hospital-Liver Research team of National Cheng Kung University Hospi
Tainan, 704
TaiwanSite Not Available
National Taiwan University Hospital-Internal Medicine ( Site 2700)
Taipei, 10002
TaiwanSite Not Available
Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (
Taipei, 11217
TaiwanSite Not Available
Chang Gung Medical Foundation-Linkou Branch ( Site 2702)
Taoyuan, 33305
TaiwanSite Not Available
Maharaj Nakorn Chiang Mai Hospital ( Site 2801)
Muang, Chiang Mai 50200
ThailandSite Not Available
Chulalongkorn University ( Site 2800)
Bangkok, Krung Thep Maha Nakhon 10330
ThailandSite Not Available
Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 2802)
Bangkok, Krung Thep Maha Nakhon 10700
ThailandSite Not Available
Hacettepe Universite Hastaneleri-internal diseases ( Site 2901)
Ankara, 06230
TurkeySite Not Available
Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2903)
Istanbul, 34093
TurkeySite Not Available
T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik -T.C. Sağlik Bakanliği- Marmara Ünivers
Istanbul, 34899
TurkeySite Not Available
Recep Tayyip Erdogan University Training and Research Hospital ( Site 2900)
Rize, 53100
TurkeySite Not Available
Dokuz Eylul Universitesi Hastanesi-Gastroenterology ( Site 2905)
İzmir, 35340
TurkeySite Not Available
Royal London Hospital ( Site 3003)
London, England E1 1BB
United KingdomSite Not Available
King's College Hospital ( Site 3002)
London, London, City Of SE5 9RL
United KingdomSite Not Available
Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 3004)
Aberdeen, Scotland AB25 2ZN
United KingdomSite Not Available
Queen Elizabeth Hospital Birmingham ( Site 3000)
Birmingham, Warwickshire B15 2TH
United KingdomSite Not Available
St James's University Hospital ( Site 3005)
Leeds, LS9 7TF
United KingdomSite Not Available
The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 3
Chandler, Arizona 85224
United StatesSite Not Available
The Institute for Liver Health II dba Arizona Clinical Trials - Peoria ( Site 3289)
Peoria, Arizona 85381
United StatesSite Not Available
Del Sol Research Management, LLC ( Site 3211)
Tucson, Arizona 85715
United StatesSite Not Available
The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 3218)
Tucson, Arizona 85712
United StatesSite Not Available
Om Research - Apple Valley ( Site 3244)
Apple Valley, California 92307
United StatesSite Not Available
Om Research LLC ( Site 3245)
Camarillo, California 93012
United StatesSite Not Available
Velocity Clinical Research, Gardena ( Site 3225)
Gardena, California 90247
United StatesSite Not Available
Velocity Clinical Research, Huntington Park ( Site 3217)
Huntington Park, California 90255
United StatesSite Not Available
Velocity Clinical Research, San Diego ( Site 3226)
La Mesa, California 91942
United StatesSite Not Available
Om Research LLC ( Site 3229)
Lancaster, California 93534
United StatesSite Not Available
Velocity Clinical Research, Westlake ( Site 3216)
Los Angeles, California 90057
United StatesSite Not Available
Velocity Clinical Research, Panorama City ( Site 3214)
Panorama City, California 91402
United StatesSite Not Available
California Liver Research Institute ( Site 3232)
Pasadena, California 91105
United StatesSite Not Available
Clinical Trials Research ( Site 3230)
Sacramento, California 95821
United StatesSite Not Available
Excel Medical Clinical Trials ( Site 3246)
Boca Raton, Florida 33434
United StatesSite Not Available
Synergy Healthcare ( Site 3286)
Bradenton, Florida 34208
United StatesSite Not Available
Synergy Healthcare LLC ( Site 3290)
Brandon, Florida 33511
United StatesSite Not Available
Top Medical Research ( Site 3209)
Cutler Bay, Florida 33189
United StatesSite Not Available
Covenant Metabolic Specialists, LLC ( Site 3231)
Fort Myers, Florida 33912
United StatesSite Not Available
Velocity Clinical Research, Hallandale Beach ( Site 3241)
Hallandale Beach, Florida 33009
United StatesSite Not Available
Indago Research & Health Center, Inc ( Site 3207)
Hialeah, Florida 33012
United StatesSite Not Available
Sweet Hope Research Specialty, Inc-Research ( Site 3200)
Hialeah, Florida 33016
United StatesSite Not Available
Florida Research Institute ( Site 3243)
Lakewood Ranch, Florida 34211
United StatesSite Not Available
Genoma Research Group ( Site 3242)
Miami, Florida 33173
United StatesSite Not Available
Floridian Clinical Research, LLC ( Site 3203)
Miami Lakes, Florida 33016-1518
United StatesSite Not Available
Southeast Clinical Research Center ( Site 3288)
Dalton, Georgia 30720
United StatesSite Not Available
Eagle Clinical Research ( Site 3233)
Chicago, Illinois 60621
United StatesSite Not Available
University of Iowa ( Site 3213)
Iowa City, Iowa 52242
United StatesSite Not Available
Kansas City Research Institute ( Site 3249)
Kansas City, Missouri 64131
United StatesSite Not Available
The Machuca Foundation ( Site 3234)
Las Vegas, Nevada 89101
United StatesSite Not Available
Velocity Clinical Research, Syracuse ( Site 3227)
East Syracuse, New York 13057
United StatesSite Not Available
New York Gastroenterology Associates ( Site 3252)
New York, New York 10075
United StatesSite Not Available
Velocity Clinical Research, Cincinnati ( Site 3237)
Cincinnati, Ohio 45242
United StatesSite Not Available
Velocity Clinical Research, Providence ( Site 3222)
East Greenwich, Rhode Island 02818
United StatesSite Not Available
Velocity Clinical Research, Austin ( Site 3235)
Austin, Texas 78759
United StatesSite Not Available
South Texas Research Institute - Brownsville ( Site 3285)
Brownsville, Texas 78520
United StatesSite Not Available
Velocity Clinical Research, Dallas ( Site 3220)
Dallas, Texas 75230
United StatesSite Not Available
Houston Research Institute ( Site 3262)
Houston, Texas 77079
United StatesSite Not Available
American Research Corporation ( Site 3202)
San Antonio, Texas 78215
United StatesSite Not Available
Pinnacle Clinical Research ( Site 3284)
San Antonio, Texas 78229
United StatesSite Not Available
Velocity Clinical Research, Salt Lake City ( Site 3223)
West Jordan, Utah 84088
United StatesSite Not Available
Gastroenterology Consultants of South West Virginia ( Site 3282)
Roanoke, Virginia 24014
United StatesActive - Recruiting
Gastroenterology Consultants of Southwest Virginia ( Site 3282)
Roanoke, Virginia 24014
United StatesSite Not Available
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