Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)
NCT ID: NCT04822181
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1205 participants
INTERVENTIONAL
2021-04-01
2029-04-25
Brief Summary
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Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance.
Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week.
The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day.
Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The trial has two parts, a part 1 and a part 2, in part 2 sponsor will be unblinded
Study Groups
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Semaglutide OW (once weekly )
Semaglutide administrated subcutaneously once weekly
Semaglutide
Semaglutide administrated subcutaneously (under the skin) once weekly there will be a period of dose escalation before reaching the target dose.
Placebo
Placebo administrated subcutaneously once weekly
Placebo
Placebo administrated subcutaneously (under the skin) once weekly.
Interventions
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Semaglutide
Semaglutide administrated subcutaneously (under the skin) once weekly there will be a period of dose escalation before reaching the target dose.
Placebo
Placebo administrated subcutaneously (under the skin) once weekly.
Eligibility Criteria
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Inclusion Criteria
* Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to the screening visit (V1).
* Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN (Clinical Research Network) classification based on a central pathologist evaluation of the baseline liver biopsy.
* A histological NAS (Non-alcoholic fatty liver disease Activity Score) above or equal to 4 with a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy.
Exclusion Criteria
* Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).
* Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.
* Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).
* Treatment with vitamin E (at doses greater than or equal to 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose from time of biopsy until screening.
* Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening (V2A).
* Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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North AL Health Res, LLC
Huntsville, Alabama, United States
The Institute for Liver Health
Chandler, Arizona, United States
Inst-Liver Hlth dba AZ Liver H
Peoria, Arizona, United States
Inst. Liver H II dba AZ Liver H
Tucson, Arizona, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
ARcare Center for Clinical Research
Jonesboro, Arkansas, United States
ARcare Center for Clinical Research
Little Rock, Arkansas, United States
Arkansas Diagnostic Center, PA
Little Rock, Arkansas, United States
Gastroenterology & Liver Institute
Escondido, California, United States
UCSD NAFLD Research Center
La Jolla, California, United States
OM Research LLC
Lancaster, California, United States
Digestive Hlth Res of SoCa
Long Beach, California, United States
OM Research LLC
Oxnard, California, United States
Cedars-Sinai Medical Center
Pasadena, California, United States
Pasedena Liver Center
Pasadena, California, United States
UC Davis Hlth -Midtwn Ambu Cen
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
Silicon Valley Res Inst
San Jose, California, United States
Peak Gastro Assoc-Col Springs
Colorado Springs, Colorado, United States
Yale Ctr for Clin Invest
New Haven, Connecticut, United States
Encore Medical Research of Boynton Beach LLC
Boynton Beach, Florida, United States
Integrity Clinical Research, LLC
Doral, Florida, United States
University of Florida-CTRB
Gainesville, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Florida Research Institute, LLC
Lakewood Rch, Florida, United States
Sandhill Research, LLC
Maitland, Florida, United States
Tandem Clinical Research - Maitland
Maitland, Florida, United States
Optimus U, Corp
Miami, Florida, United States
Univ of Miami/Schiff Ctr
Miami, Florida, United States
Genoma Research Group, Inc
Miami, Florida, United States
IMIC Inc
Miami, Florida, United States
Ocala GI Research
Ocala, Florida, United States
Sensible Healthcare LLC
Ocoee, Florida, United States
Headlands Research - Sarasota
Sarasota, Florida, United States
ClinCloud, LLC
Viera E., Florida, United States
Florida Medical Clinic Orlando Health
Zephyrhills, Florida, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Gastroenterology Assoc_ CGA
Macon, Georgia, United States
Gastroint Spec of Georgia
Marietta, Georgia, United States
Endeavor Health
Skokie, Illinois, United States
Digestive Research Alliance of Michiana
South Bend, Indiana, United States
Iowa Digestive Disease Center
Clive, Iowa, United States
University Of Kansas Hospital
Kansas City, Kansas, United States
Kansas Medical Clinic, PA
Topeka, Kansas, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Tandem Clinical Research - Metairie
Metairie, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Mercy Medical Center, GI Research
Baltimore, Maryland, United States
Walter Reed Nat Mil Md Ctr
Bethesda, Maryland, United States
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, United States
Boston Medical Center_Cary
Boston, Massachusetts, United States
Southern Therapy and Advanced Research LLC
Jackson, Mississippi, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Univ of Nebraska Medical CTR
Omaha, Nebraska, United States
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, United States
Sierra Clinical Research-Las Vegas
Las Vegas, Nevada, United States
AIG Digestive Disease Research
Florham Park, New Jersey, United States
Premier Health Research, LLC
Sparta, New Jersey, United States
NYU Grossman School of Med
New York, New York, United States
Weill Cornell Med Coll-NYPH
New York, New York, United States
Icahn Sch of Med-Mt Sinai Hosp
New York, New York, United States
Northeast GI Research Division
Concord, North Carolina, United States
Ohio State Univ Wexner Med Ctr
Columbus, Ohio, United States
Objective GI
Springboro, Ohio, United States
CRIOH
Westlake, Ohio, United States
Geisinger Clinic
Danville, Pennsylvania, United States
Pennsylvania State University
Hershey, Pennsylvania, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
UPMC Center for Liver Diseases
Pittsburgh, Pennsylvania, United States
UPMC_Center for Liver Care
Pittsburgh, Pennsylvania, United States
Care Access Research, Pottsville
Pottsville, Pennsylvania, United States
Clinical Res Collaborative
Cumberland, Rhode Island, United States
Ocean St Clin Res Partnrs, LLC
Lincoln, Rhode Island, United States
Medical University Of South Carolina
Charleston, South Carolina, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, United States
Digestive Health Res-TSMC
Hermitage, Tennessee, United States
East Tennessee Research Institute
Johnson City, Tennessee, United States
Quality Medical Research
Nashville, Tennessee, United States
Amarillo Center for Clinical Research, Ltd.
Amarillo, Texas, United States
Texas Clin Res Inst, LLC
Arlington, Texas, United States
Liver Ins@ Mthdist DTX Med Cen
Dallas, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
UT Southwestern Med Cntr
Dallas, Texas, United States
South Texas Research Institute
Edinburg, Texas, United States
Brooke Army Medical Ctr.
Fort Sam Houston, Texas, United States
GI Alliance Research
Fort Worth, Texas, United States
Bipharma Informatic Inc.
Houston, Texas, United States
Bylr Coll Md-Ben Taub Gen Hos
Houston, Texas, United States
Biopharma Informatic
Houston, Texas, United States
Amir Ali Hassan, MD, PA
Houston, Texas, United States
LinQ Research, LLC
Pearland, Texas, United States
Amer. Rrsch Corp-TX Liver Inst
San Antonio, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
Digestive Hlth Res of N Texas
Wichita Falls, Texas, United States
South Ogden Family Medicine/ CCT Research
Ogden, Utah, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Bon Secours Richmond Community Hospital LLC
Richmond, Virginia, United States
McGuire VA Medical Center
Richmond, Virginia, United States
VCU Health System
Richmond, Virginia, United States
Gastroent Consult of SW VA
Roanoke, Virginia, United States
Hospital Britanico de Buenos Aires
Ciudad de Buenos Aires, Buenos Aires, Argentina
DIM Clinica Privada
Buenos Aires, , Argentina
Centro Médico Viamonte SRL
CABA, , Argentina
Hospital Italiano Departamento Hepatologia
CABA, , Argentina
Glenny Corp. S.A
CABA, , Argentina
Centro de Investigaciones Metabólicas
Capital Federal, , Argentina
Centro de Investigaciones Metabólicas
Capital Federal, , Argentina
Hospital El Cruce
Florencio Varela, Buenos Aires, , Argentina
A.W. Morrow Gastroenterology and Liver Centre
Camperdown, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Griffith University Clinical Trial Unit
Southport, Queensland, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
St Vincent's Hospital (Melbourne)
Fitzroy, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Fiona Stanley Hospital - Hepatology
Murdoch, Western Australia, Australia
Sir Charles Gairdner Hospital_Nedlands
Nedlands, Western Australia, Australia
Klinik Landstraße
Vienna, , Austria
CUB Hôpital Erasme_Brussels_0
Brussels, , Belgium
Cliniques Universitaires Saint-Luc - Serv. Hépato-gastroentérology
Brussels, , Belgium
AZ Maria Middelares - Gent - Gastro-Enterology
Ghent, , Belgium
UZ Gent - Department Gastro-enterology
Ghent, , Belgium
Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, Goiás, Brazil
Hospital de Clínicas de Porto Alegre_Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII
Barretos, São Paulo, Brazil
Fundação Pio XII - Hospital de Amor de Barretos
Barretos, São Paulo, Brazil
UPECLIN- Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil
CIP Centro Integrado de Pesquisas do Hospital de Base
São José do Rio Preto, São Paulo, Brazil
Assoc. Paulista para o Desenvolvimento da Medicina - UNIFESP
São Paulo, São Paulo, Brazil
Departamento de Gastroenterologia - HCFMUSP
São Paulo, São Paulo, Brazil
Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, , Brazil
Rocco e Nazato Servicos Medicos LTDA
São Paulo, , Brazil
"Acibadem City Clinic UMHAT Tokuda"
Sofia, , Bulgaria
DCC Aleksandrovska EOOD
Sofia, , Bulgaria
UMHAT "Sv. Ivan Rilski", Clinic of Gastroenterology
Sofia, , Bulgaria
"UMHAT "Tsaritsa Yoanna-ISUL"" EAD, Gastroenterology clinic
Sofia, , Bulgaria
"DCC XX - Sofia" EOOD
Sofia, , Bulgaria
"UMHAT "Sveta Anna" Sofia" AD
Sofia, , Bulgaria
Medical Center Synexus Sofia EOOD
Sofia, , Bulgaria
University of Calgary Liver Unit-(HMRC)
Calgary, Alberta, Canada
GI Research Inst Foundation
Vancouver, British Columbia, Canada
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, Canada
London Hlth Sci Ctr- Univ Camp
London, Ontario, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
TDDA Specialty Research
Vaughan, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Hospital Fleurimont / CIUSS
Sherbrooke, Quebec, Canada
Ctr de Med Metab de Lanaudiere
Terrebonne, Quebec, Canada
Beijing Ditan Hospital Capital Medical University-Hepatology
Beijing, Beijing Municipality, China
Peking University People's Hospital-(White Pagoda Temple Area) - Hepatopathy
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University-Endocrinology
Beijing, Beijing Municipality, China
Beijing You'an Hospital, Capital Medical University-Hepatology center
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital-Hepatology
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital-Hepatology
Chongqing, Chongqing Municipality, China
The First People's Hospital of Foshan-Infectious Disease
Foshan, Guangdong, China
Guangzhou Eighth People's Hospital, Guangzhou Medical University-Hepatology
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Guangzhou First People's Hospital-Gastroenterology
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University-Infectious Diseases
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-sen University-Infectious
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The Third People's Hospital of Shenzhen-Hepatology
Shenzhen, Guangdong, China
The Third Hospital of Hebei Medical University-Hepatology
Shijiazhuang, Hebei, China
Hunan Provincial People's Hospital-Hepatology
Changsha, Hunan, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University (East) - Infectious Diseases
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University-Hepatic Biliary Pancreatic Medicine
Changchun, Jilin, China
General Hosp of Ningxia Medical University,Infectious Depart
Yinchuan, Ningxia, China
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong, China
Liaocheng People's Hospital-Infectious Diseases
Liaocheng, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Qingdao Municipal Hospital (Group)-Infectious Diseases
Qingdao, Shandong, China
Shanghai Jiao Tong University School of Medicine Renji Hospital-Gastroenterology
Shanghai, Shanghai Municipality, China
Ruijin Hospital Affiliate to The Shanghai Jiaotong University-Infectious Diseases
Shanghai, Shanghai Municipality, China
Ruijin Hospital Affiliate to The Shanghai Jiaotong Universit
Shanghai, Shanghai Municipality, China
Shanghai Ninth People's Hospital-Infection Disease
Shanghai, Shanghai Municipality, China
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China
West China Hospital Sichuan University-Infectious Diseases
Chengdu, Sichuan, China
Tianjin Third Central Hospital-Gastroenterology
Tianjin, Tianjin Municipality, China
Tianjin Second People's Hospital-Liver Disease Department III
Tianjin, Tianjin Municipality, China
Zhejiang Hospital-Infectious Diseases
Hangzhou, Zhejiang, China
The First Affiliated Hospital of WMU
Wenzhou, Zhejiang, China
Zhejiang Hospital-Infectious Diseases
Hangzhou, , China
The Third People's Hospital of Shenzhen
Shenzhen, , China
Tianjin Second People's Hospital-Liver Disease Department III
Tianjin, , China
Klinicki bolnicki centar Osijek
Osijek, , Croatia
KBC Rijeka, Zavod za gastroenterologiju
Rijeka, , Croatia
KBC Split/ Firule/ Gastroenterologija
Split, , Croatia
KB Dubrava, Zavod za gastroenterologiju
Zagreb, , Croatia
Klinički bolnički centar Zagreb, Zavod za gastroenterologiju
Zagreb, , Croatia
Krajská nemocice Liberec, a.s
Liberec, , Czechia
Researchsite s.r.o.
Pilsen, , Czechia
Vseobecna Fakultni nemocnice v Praze
Prague, , Czechia
Aarhus Universitetshospital Skejby Mave-Tarm
Aarhus N, , Denmark
Hvidovre Hospital - Gastroenheden
Hvidovre, , Denmark
Abdominal Center K, Research Unit
København NV, , Denmark
Odense University Hospital
Odense C, , Denmark
Centre Hospitalier Universitaire D'Angers-1
Angers, , France
Ap-Hp-Hopital Beaujon
Clichy, , France
Centre Hospitalier Universitaire de Lille-Hopital Claude Huriez
Lille, , France
Centre Hospitalier Universitaire de Nice-Hopital de L'Archet 2
Nice, , France
Aphp-Hopital La Pitie Salpetriere-4
Paris, , France
Ap-Hp-Hopital Cochin
Paris, , France
Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH
Leipzig, , Germany
Universitätsklinikum Leipzig - Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie
Leipzig, , Germany
Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck
Lübeck, , Germany
Universitätsmedizin der JGU Mainz - Hepatologie
Mainz, , Germany
Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
Athens, , Greece
General Hospital of Athens "LAIKO"
Goudi, Athens, , Greece
AHEPA General University Hospital
Thessaloniki, , Greece
General Hospital of Thessaloniki "Ippokrateio"
Thessaloniki, , Greece
Yashoda Hospital
Secunderabad, Andhra Pradesh, India
Surat Institute of Digestive Science
Surat, Gujarat, India
Kasturba Medical College Hospitals (KMC Hospitals), Mangalore
Mangalore, Karnataka, India
Gleneagles Hospital, Super-speciality and Transplant Centre, Parel
Mumbai, Maharashtra, India
Seth GS medical college and KEM Hospital
Mumbai, Maharashtra, India
Midas Multispeciality Hospital
Nagpur, Maharashtra, India
All India Institute of medical Sciences
Delhi, New Delhi, India
Institute of liver and Biliary Sciences
Ghitorni, New Delhi, India
Post Graduate Institute of Medical Education & Research_Chandigarh
Chandigarh, Punjab, India
Dayanand Medical College & Hospital
Ludhiana, Punjab, India
Fortis Heart Institute and Multispeciality Hospital
Mohali, Punjab, India
S.R.Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India
SMS Super speciality Hospital, Department of Gastroenterology
Jaipur, Rajasthan, India
Hepatology St James's
Dublin, , Ireland
Beaumont Hospital Hepatology Dept
Dublin, , Ireland
Carmel MC - Liver Unit
Haifa, , Israel
Carmel Medical Center Liver Unit
Haifa, , Israel
Shaare Zedek MC - Liver Unit
Jerusalem, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah Ein Karam MC - Liver Unit
Jerusalem, , Israel
Liver Institute, Rabin Medical Center, Beilinson Campuse
Petah Tikva, , Israel
Rabin MC Beilinson - Liver Institute
Petah Tikva, , Israel
Sheba MC - Liver Diseases Center
Ramat Gan, , Israel
Sourasky MC - Liver Unit
Tel Aviv, , Israel
Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, Cz, Italy
AOUP Giaccone Palermo
Palermo, Sicily, Italy
Azieda Ospedaliero-Universitaria, Policlinico S. Orsola-Malp
Bologna, , Italy
Osp Magg Policlinico Centro Malattie metaboliche del Fegato
Milan, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCS
Roma, , Italy
Policlinico Università Campus Biomedico di Roma
Rome, , Italy
Città della salute e della scienza - university of Torino
Torino, , Italy
Juntendo University Hospital, Gastroenterology
Bunkyo-ku, Tokyo, , Japan
The University of Tokyo Hospital, Gastroenterology
Bunkyo-ku, Tokyo, , Japan
Fukui-ken Saiseikai Hospital, Internal Medicine
Fukui-shi, Fukui, , Japan
Hoshi General Hospital_Gastroenterology
Fukushima, , Japan
Gifu Municipal Hospital_Hepatology
Gifu, , Japan
Ogaki Municipal Hospital_Gastroenterology and Hepatology
Gifu, , Japan
Hamamatsu University Hospital
Hamamatsu-shi, Shizuoka, , Japan
JA Hiroshima General Hospital_Gastroenterology and Hepatology
Hatsukaichi-shi, Hiroshima, , Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hosp.
Hiroshima-shi, Hiroshima, , Japan
Hiroshima University Hospital
Hiroshima-shi, Hiroshima, , Japan
Juntendo University Shizuoka Hospital
Izunokuni-shi, Shizuoka, , Japan
Kagoshima University Hospital, Gastroenterology
Kagoshima-shi, Kagoshima, , Japan
University Hospital Kyoto Prefectual University of Medicine
Kamigyo-ku, Kyoto, , Japan
Kanazawa University Hospital
Kanazawa-shi, Ishikawa, , Japan
Nara Medical University Hospital_Kashihara-shi, Nara
Kashihara-shi, Nara, , Japan
St. Marianna University School of Medicine Hospital
Kawasaki-shi, Kanagawa, , Japan
Kumamoto Shinto General Hospital_Liver・Gastroenterology
Kumamoto-shi, Kumamoto, , Japan
Toranomon Hospital, Hepatology
Minato-ku, Tokyo, , Japan
Japanese Red Cross Musashino Hospital_Gastroenterology
Musashino-shi, Tokyo, , Japan
Japanese Red Cross Musashino Hospital
Musashino-shi, Tokyo, , Japan
Aichi Medical University Hospital
Nagakute-shi, Aichi, , Japan
Heartlife Hospital_Liver internal medicine
Nakagamigun, Okinawa, , Japan
Nara City Hospital, Gastroenterology and Hepatology
Nara-shi, Nara, , Japan
Hyogo Medical University Hospital_Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine
Nishinomiya-shi, Hyogo, , Japan
Oita Cardiovascular Hospital_Gastroenterology
Oita-shi, Oita, , Japan
Kawasaki Medical School General Medical Center_Internal Medicine
Okayama-shi, Okayama, , Japan
Kawasaki Medical School General Medical Center
Okayama-shi, Okayama, , Japan
Japan Organization of Occupational Health and Safety Osaka Rosai Hospital_Gastroenterology
Osaka, , Japan
Osaka Metropolitan University Hospital, Department of Hepatology
Osaka-shi, Osaka, , Japan
Otsu City Hospital, Gastroenterological Medicine
Otsu-shi, Shiga, , Japan
Saga University Hospital_Liver Center
Saga-shi, Saga, , Japan
Japan Community Health care Organization Hokkaido Hospital
Sapporo-shi, Hokkaido, , Japan
JCHO Hokkaido Hospital_Digestive Disease Center
Sapporo-shi, Hokkaido, , Japan
Sendai Kousei Hospital
Sendai-shi, Miyagi, , Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, , Japan
Saiseikai Suita Hospital, Gastroenterology
Suita-shi, Osaka, , Japan
Kagawa Prefectural Central Hospital
Takamatsu-shi, Kagawa, , Japan
National Hospital Organization Takasaki General Medical Ctr.
Takasaki-shi, Gunma, , Japan
Nihon University Itabashi Hospital_Division of Gastro.&Hepa.
Tokyo, , Japan
Nihon University Itabashi Hospital
Tokyo, , Japan
Ehime University Hospital_Department of Gastro.& Metabo.
Toon-shi, Ehime, , Japan
Ehime University Hospital
Toon-shi, Ehime, , Japan
Saiseikai Wakayama Hospital_Gastroenterology
Wakayama-shi, Wakayama, , Japan
Saiseikai Wakayama Hospital
Wakayama-shi, Wakayama, , Japan
Yokohama City University Hospital, Gastrointestinal Medicine
Yokohama-shi, Kanagawa, , Japan
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Selayang
Batu Caves, , Malaysia
Centro de Investigacion Clinica del Pacifico, S.A. de C.V.
Acapulco de Juárez, Guerrero, Mexico
Centro de Investigación Médico Biológica y Terapia
Guadalajara, Jalisco, Mexico
Centro de Investigación y Gastroenterología, S.C.
Mexico City, México, D.F., Mexico
Investigaciones Médicas Cisneros, S.C.
Monterrey, Nuevo León, Mexico
Servicios de Oncologia Medica Integral S.A de C.V (ONCARE)
San Pedro Garza García, Nuevo León, Mexico
Hospital Angeles de Culiacan
Culiacán, Sinaloa, Mexico
Medical Care and Research S. A de C.V
Mérida, Yucatán, Mexico
Centro de Investigación y Gastroenterología_ Hospital Angeles Universidad
México, , Mexico
Noordwest Ziekenhuisgroep
Alkmaar, , Netherlands
Academisch Medisch Centrum
Amsterdam, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Bærum sykehus
Gjettum, , Norway
Oslo universitetssykehus, Ullevål
Oslo, , Norway
ID Clinic Arkadiusz Pisula
Myslowice, Lesser Poland Voivodeship, Poland
BodyClinic
Warsaw, , Poland
Centrum Badan Klinicznych
Wroclaw, , Poland
FutureMeds Sp. z o.o.
Wroclaw, , Poland
Ko-Med Centra Kliniczne Staszow
Staszów, Świętokrzyskie Voivodeship, Poland
Unidade Local De Saude De Matosinhos E.P.E.
Senhora Da Hora, Matosinhos, Matosinhos, Portugal
Hospital Garcia de Orta
Almada, , Portugal
Unidade Local De Saude De Almada-Seixal E.P.E. - Hospital Garcia de Orta
Almada, , Portugal
Unidade de Local de Saúde de Braga
Braga, , Portugal
Unidade Local De Saude Da Guarda E.P.E. - Hospital Sousa Martins
Guarda, , Portugal
APDP - Associação Protectora dos Diabéticos de Portugal
Lisbon, , Portugal
Unidade Local De Saude De Santa Maria E.P.E.
Lisbon, , Portugal
Unidade Local de Saúde de Santo António, E.P.E
Porto, , Portugal
Unidade Local de Saúde do Alto Minho E.P.E. - Viana do Castelo
Viana do Castelo, , Portugal
Hospital Luz Arrabida, S.A.
Vila Nova de Gaia, , Portugal
Unidade Local De Saude De Gaia/Espinho E.P.E.
Vila Nova de Gaia, , Portugal
FDI Clinical Research
San Juan, , Puerto Rico
SC Diamed Obesity SRL
Galati, , Romania
Spital Judetean De Urgenta Satu Mare
Satu Mare, , Romania
Volosevich First City Clinical Hospital
Arkhangelsk, , Russia
Kazan Federal University
Kazan', , Russia
Friendship University of Russia
Moscow, , Russia
Limited Law Company "Healthy Family" Medicine Center"
Novosibirsk, , Russia
Joint Stock Company "Polyclinic Complex"
Saint Petersburg, , Russia
Limited Liability Company "Energiya Zdoroviya"
Saint Petersburg, , Russia
North-Western State Medical Univer. based on Med-Prof Center
Saint Petersburg, , Russia
Consultative & Diagnostic Center with a Outpatient Hospital
Saint Petersburg, , Russia
Ulianovsk Regional Clinical Hospital
Ulyanovsk, , Russia
Polyclinic #2 in Yoshkar-Ola
Yoshkar-Ola, , Russia
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad, Vojvodina, Serbia
Clinic for gastroenterology and hepatology
Belgrade, , Serbia
Clinical-hospital centre Zvezdara
Belgrade, , Serbia
National University Hospital Singapore_Tahir Building
Singapore, , Singapore
National University Hospital_Tahir Building
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Changi General Hospital
Singapore, , Singapore
Nemocnica akademika L. Derera, UNB
Bratislava, , Slovakia
MEDISPEKTRUM s.r.o.
Bratislava, , Slovakia
Phoenix Pharma
Port Elizabeth, Eastern Cape, South Africa
Chris Hani Baragwanath Hospital
Johannesburg, Gauteng, South Africa
WITS Clinical Research
Johannesburg, Gauteng, South Africa
Lenasia Clinical Trial Centre
Lenasia, Gauteng, South Africa
Maxwell Centre
Durban, KwaZulu-Natal, South Africa
Tiervlei Trial Centre
Cape Town, Western Cape, South Africa
Dr Rajabally's Practice
Cape Town, Western Cape, South Africa
Wits Health Consortium
Johannesburg, , South Africa
Kyungpook National University Hospital
Daegu, , South Korea
Yeungnam Univ. Medical Center
Daegu, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Wonju Severance Christian Hospital
Gangwon-do, , South Korea
SoonChunHyang University Hospital Bucheon
Gyeonggi-do, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Complejo Hospitalario de Pontevedra - Hospital de Montecelo
Pontevedra, Galicia, Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Complejo Hospitalario de Pontevedra - Hospital de Montecelo
Pontevedra, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Hospital Clínico de Valladolid
Valladolid, , Spain
Universitätsklinik für Viszerale Chirurgie und Medizin
Bern, , Switzerland
Hôpitaux Universitaires de Genève
Geneva, , Switzerland
Kantonsspital Olten
Olten, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Taipei Tzu Chi Hospital
New Taipei City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital_main
Taipei, , Taiwan
Taipei-Veterans General Hospital - Dept of Gastrointestinal
Taipei, , Taiwan
T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
Adana, , Turkey (Türkiye)
Ankara Universitesi Tıp Fakultesi Gastroenteroloji Bilim Da
Ankara, , Turkey (Türkiye)
Ankara Sehir Hastanesi,Gastroenteroloji Klinigi
Ankara, , Turkey (Türkiye)
Uludag Universitesi Tıp Fakultesi-Gastroenteroloji
Bursa, , Turkey (Türkiye)
Koc Universitesi Hastanesi-Gastroenteroloji
Istanbul, , Turkey (Türkiye)
Bezmialem Vakıf Üniversitesi Hastanesi-Gastroenteroloji
Istanbul, , Turkey (Türkiye)
Marmara Univ. Pendik Gastroenterology
Istanbul, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi, Gastroenteroloji
Izmir, , Turkey (Türkiye)
Kocaeli Universitesi Tıp Fakültesi Gastroenteroloji ve Hepat
Kocaeli, , Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Gastroenteroloji Bilim Dal
Mersin, , Turkey (Türkiye)
Queen Elizabeth Hospital, Birmingham
Birmingham, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Royal Devon University Healthcare NHS Foundation Trust
Exeter, , United Kingdom
Hull Royal Infirmary_Hull
Hull, , United Kingdom
The Diabetes Centre
Ipswich, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
St. James University Hospital
Leeds, , United Kingdom
Royal Free - Immunity & Transplantation
London, , United Kingdom
Chelsea & Westminster Hospital
London, , United Kingdom
Imperial College London
London, , United Kingdom
Freeman Hospital, Newcastle
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospital
Nottingham, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Joint Clinical Research Facility - Swansea
Swansea, , United Kingdom
Countries
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References
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Newsome PN, Sanyal AJ, Engebretsen KA, Kliers I, Ostergaard L, Vanni D, Bugianesi E, Rinella ME, Roden M, Ratziu V. Semaglutide 2.4 mg in Participants With Metabolic Dysfunction-Associated Steatohepatitis: Baseline Characteristics and Design of the Phase 3 ESSENCE Trial. Aliment Pharmacol Ther. 2024 Dec;60(11-12):1525-1533. doi: 10.1111/apt.18331. Epub 2024 Oct 16.
Sanyal AJ, Newsome PN, Kliers I, Ostergaard LH, Long MT, Kjaer MS, Cali AMG, Bugianesi E, Rinella ME, Roden M, Ratziu V; ESSENCE Study Group. Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis. N Engl J Med. 2025 Jun 5;392(21):2089-2099. doi: 10.1056/NEJMoa2413258. Epub 2025 Apr 30.
Rowe IA, Allen AM. Hepatic steatosis provides the terroir that promotes the development of cardiovascular risk factors and disease. Hepatology. 2023 Jun 1;77(6):1843-1845. doi: 10.1097/HEP.0000000000000327. Epub 2023 Feb 6. No abstract available.
Other Identifiers
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U1111-1244-3678
Identifier Type: OTHER
Identifier Source: secondary_id
2019-004594-44
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2031210033
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN9931-4553
Identifier Type: -
Identifier Source: org_study_id
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