Clinical trial NCT04822181: Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)
Official title: The Effect of Semaglutide in Subjects With Non-cirrhotic Non-alcoholic Steatohepatitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Non-alcoholic Steatohepatitis
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-03-30
Enrollment: 1205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries.

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.


Eligibility criteria: Inclusion Criteria:

* Age above or equal to 18 years at the time of signing informed consent.
* 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:

* Documented causes of chronic liver disease other than non-alcoholic fatty liver disease (NAFLD)
* 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.

Primary outcomes:
measure: Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
timeFrame: From randomisation (week 0) to week 72
measure: Part 1: Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No)
timeFrame: From randomisation (week 0) to week 72
measure: Part 2: Cirrhosis-free survival (Yes/No)
timeFrame: From randomisation (week 0) to week 240
Secondary outcomes:
measure: Change in body weight
timeFrame: From randomisation (week 0) to week 72
measure: Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No)
timeFrame: From randomisation (week 0) to week 72
measure: Change in SF-36 (Short Form 36) Bodily Pain
timeFrame: From randomisation (week 0) to week 72
measure: Change in body weight
timeFrame: From randomisation (week 0) to week 240
measure: Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No)
timeFrame: From randomisation (week 0) to week 72
measure: Change in histology-assessed liver collagen proportionate area
timeFrame: From randomisation (week 0) to week 72
measure: Worsening in steatohepatitis (Yes/No)
timeFrame: From randomisation (week 0) to week 72
measure: Improvement in histology-assessed ballooning (Yes/No)
timeFrame: From randomisation (week 0) to week 72
measure: Improvement in histology-assessed inflammation (Yes/No)
timeFrame: From randomisation (week 0) to week 72
measure: Improvement in histology-assessed steatosis (Yes/No)
timeFrame: From randomisation (week 0) to week 72
measure: NASH resolution (ballooning of 0, inflammation of 0-1) and above or equal to 2point NAS reduction with no worsening of fibrosis
timeFrame: From randomisation (week 0) to week 72
measure: Progression of liver fibrosis in patients with F2 at baseline (Yes/No)
timeFrame: From randomisation (week 0) to week 72
measure: Progression of liver fibrosis
timeFrame: From randomisation (week 0) to week 72
measure: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
timeFrame: From randomisation (week 0) to week 240
measure: Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No)
timeFrame: From randomisation (week 0) to week 240
measure: Absence of histological evidence of NASH (Yes/No)
timeFrame: From randomisation (week 0) to week 240
measure: Changes in liver stiffness values assessed by transient elastography (FibroScan®)
timeFrame: From randomisation (week 0) to week 72 and week 240
measure: Change in ELF (Enhanced Liver Fibrosis) score
timeFrame: From randomisation (week 0) to week 72 and week 240
measure: Change in ALT (alanine aminotransferase)
timeFrame: From randomisation (week 0) to week 72 and week 240
measure: Change in AST (aspartate aminotransferase)
timeFrame: From randomisation (week 0) to week 72 and week 240
measure: Change in CAP (Controlled Attenuation Parameter) values assessed by transient elastography (FibroScan)
timeFrame: From randomisation (week 0) to week 72 and week 240
measure: Change in FAST (FibroScan-AST) score
timeFrame: From randomisation (week 0) to week 72 and week 240
measure: Change in Pro-C3 (pro-peptide of type III collagen)
timeFrame: From randomisation (week 0) to week 72 and week 240
measure: Change in inflammation assessed by hsCRP (High Sensitive C-Reactive Protein)
timeFrame: From randomisation (week 0) to week 72 and week 240
measure: Change in HbA1c (glycated haemoglobin)
timeFrame: From randomisation (week 0) to week 72 and week 240
measure: Change in triglyceride
timeFrame: From randomisation (week 0) to week 72 and week 240
measure: Change in free fatty acids
timeFrame: From randomisation (week 0) to week 72 and week 240
measure: Change in LDL (low-density lipoprotein) cholesterol
timeFrame: From randomisation (week 0) to week 72 and week 240
measure: Change in HDL (High density lipoprotein ) cholesterol
timeFrame: From randomisation (week 0) to week 72 and week 240
measure: Time to first MACE(Major Adverse Cardiovascular event ) (composite endpoint)
timeFrame: From randomisation (week 0) to week 240
measure: Major cardio-hepatic event-free survival (Yes/No)
timeFrame: From randomisation (week 0) to week 240
measure: Changes in SF-36 (Short Form 36 v2.0 acute ) Physical Component Summary
timeFrame: From randomisation (week 0) to week 72 and week 240
measure: Changes in SF-36 Mental Component Summary
timeFrame: From randomisation (week 0) to week 72 and week 240
measure: Change in SF-36 Bodily Pain
timeFrame: From randomisation (week 0) to week 240
measure: Changes in NASH-CHECK Abdominal Pain
timeFrame: From randomisation (week 0) to week 72 and week 240
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: North AL Health Res, LLC
state: Alabama
city: Chandler
country: United States
facility: The Institute for Liver Health
state: Arizona
city: Peoria
country: United States
facility: Inst-Liver Hlth dba AZ Liver H
state: Arizona
city: Tucson
country: United States
facility: Inst. Liver H II dba AZ Liver H
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Jonesboro
country: United States
facility: ARcare Center for Clinical Research
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Diagnostic Center, PA
state: Arkansas
city: Escondido
country: United States
facility: Gastroenterology & Liver Institute
state: California
city: La Jolla
country: United States
facility: UCSD NAFLD Research Center
state: California
city: Lancaster
country: United States
facility: OM Research LLC
state: California
city: Long Beach
country: United States
facility: Digestive Hlth Res of SoCa
state: California
city: Oxnard
country: United States
facility: OM Research LLC
state: California
city: Pasadena
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Pasadena
country: United States
facility: Pasedena Liver Center
state: California
city: Sacramento
country: United States
facility: UC Davis Hlth -Midtwn Ambu Cen
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: San Jose
country: United States
facility: Silicon Valley Res Inst
state: California
city: Colorado Springs
country: United States
facility: Peak Gastro Assoc-Col Springs
state: Colorado
city: New Haven
country: United States
facility: Yale Ctr for Clin Invest
state: Connecticut
city: Boynton Beach
country: United States
facility: Encore Medical Research of Boynton Beach LLC
state: Florida
city: Doral
country: United States
facility: Integrity Clinical Research, LLC
state: Florida
city: Gainesville
country: United States
facility: University of Florida-CTRB
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Research Institute, LLC
state: Florida
city: Maitland
country: United States
facility: Sandhill Research, LLC
state: Florida
city: Maitland
country: United States
facility: Tandem Clinical Research - Maitland
state: Florida
city: Miami
country: United States
facility: Optimus U, Corp
state: Florida
city: Miami
country: United States
facility: Univ of Miami/Schiff Ctr
state: Florida
city: Miami
country: United States
facility: Genoma Research Group, Inc
state: Florida
city: Miami
country: United States
facility: IMIC Inc
state: Florida
city: Ocala
country: United States
facility: Ocala GI Research
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare LLC
state: Florida
city: Sarasota
country: United States
facility: Headlands Research - Sarasota
state: Florida
city: Viera E.
country: United States
facility: ClinCloud, LLC
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic Orlando Health
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Assoc_ CGA
state: Georgia
city: Marietta
country: United States
facility: Gastroint Spec of Georgia
state: Georgia
city: Skokie
country: United States
facility: Endeavor Health
state: Illinois
city: South Bend
country: United States
facility: Digestive Research Alliance of Michiana
state: Indiana
city: Clive
country: United States
facility: Iowa Digestive Disease Center
state: Iowa
city: Kansas City
country: United States
facility: University Of Kansas Hospital
state: Kansas
city: Topeka
country: United States
facility: Kansas Medical Clinic, PA
state: Kansas
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Metairie
country: United States
facility: Tandem Clinical Research - Metairie
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center, GI Research
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed Nat Mil Md Ctr
state: Maryland
city: Glen Burnie
country: United States
facility: Woodholme Gastroenterology Associates
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center_Cary
state: Massachusetts
city: Jackson
country: United States
facility: Southern Therapy and Advanced Research LLC
state: Mississippi
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Omaha
country: United States
facility: Univ of Nebraska Medical CTR
state: Nebraska
city: Las Vegas
country: United States
facility: Jubilee Clinical Research, Inc.
state: Nevada
city: Las Vegas
country: United States
facility: Sierra Clinical Research-Las Vegas
state: Nevada
city: Florham Park
country: United States
facility: AIG Digestive Disease Research
state: New Jersey
city: Sparta
country: United States
facility: Premier Health Research, LLC
state: New Jersey
city: New York
country: United States
facility: NYU Grossman School of Med
state: New York
city: New York
country: United States
facility: Weill Cornell Med Coll-NYPH
state: New York
city: New York
country: United States
facility: Icahn Sch of Med-Mt Sinai Hosp
state: New York
city: Concord
country: United States
facility: Northeast GI Research Division
state: North Carolina
city: Columbus
country: United States
facility: Ohio State Univ Wexner Med Ctr
state: Ohio
city: Springboro
country: United States
facility: Objective GI
state: Ohio
city: Westlake
country: United States
facility: CRIOH
state: Ohio
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Hershey
country: United States
facility: Pennsylvania State University
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Center for Liver Diseases
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC_Center for Liver Care
state: Pennsylvania
city: Pottsville
country: United States
facility: Care Access Research, Pottsville
state: Pennsylvania
city: Cumberland
country: United States
facility: Clinical Res Collaborative
state: Rhode Island
city: Lincoln
country: United States
facility: Ocean St Clin Res Partnrs, LLC
state: Rhode Island
city: Charleston
country: United States
facility: Medical University Of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: WR-ClinSearch, LLC
state: Tennessee
city: Hermitage
country: United States
facility: Digestive Health Res-TSMC
state: Tennessee
city: Johnson City
country: United States
facility: East Tennessee Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Center for Clinical Research, Ltd.
state: Texas
city: Arlington
country: United States
facility: Texas Clin Res Inst, LLC
state: Texas
city: Dallas
country: United States
facility: Liver Ins@ Mthdist DTX Med Cen
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Med Cntr
state: Texas
city: Edinburg
country: United States
facility: South Texas Research Institute
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Ctr.
state: Texas
city: Fort Worth
country: United States
facility: GI Alliance Research
state: Texas
city: Houston
country: United States
facility: Bipharma Informatic Inc.
state: Texas
city: Houston
country: United States
facility: Bylr Coll Md-Ben Taub Gen Hos
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic
state: Texas
city: Houston
country: United States
facility: Amir Ali Hassan, MD, PA
state: Texas
city: Pearland
country: United States
facility: LinQ Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Amer. Rrsch Corp-TX Liver Inst
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
city: Wichita Falls
country: United States
facility: Digestive Hlth Res of N Texas
state: Texas
city: Ogden
country: United States
facility: South Ogden Family Medicine/ CCT Research
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Richmond Community Hospital LLC
state: Virginia
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Richmond
country: United States
facility: VCU Health System
state: Virginia
city: Roanoke
country: United States
facility: Gastroent Consult of SW VA
state: Virginia
city: Ciudad de Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: DIM Clinica Privada
city: Caba
country: Argentina
facility: Centro Médico Viamonte SRL
city: Caba
country: Argentina
facility: Hospital Italiano Departamento Hepatologia
city: Caba
country: Argentina
facility: Glenny Corp. S.A
city: Capital Federal
country: Argentina
facility: Centro de Investigaciones Metabólicas
city: Capital Federal
country: Argentina
facility: Centro de Investigaciones Metabólicas
city: Florencio Varela, Buenos Aires
country: Argentina
facility: Hospital El Cruce
city: Camperdown
country: Australia
facility: A.W. Morrow Gastroenterology and Liver Centre
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Southport
country: Australia
facility: Griffith University Clinical Trial Unit
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Fitzroy
country: Australia
facility: St Vincent's Hospital (Melbourne)
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital - Hepatology
state: Western Australia
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital_Nedlands
state: Western Australia
city: Wien
country: Austria
facility: Klinik Landstraße
city: Bruxelles
country: Belgium
facility: CUB Hôpital Erasme_Brussels_0
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc - Serv. Hépato-gastroentérology
city: Gent
country: Belgium
facility: AZ Maria Middelares - Gent - Gastro-Enterology
city: Gent
country: Belgium
facility: UZ Gent - Department Gastro-enterology
city: Goiânia
country: Brazil
facility: Hospital das Clínicas da Universidade Federal de Goiás
state: Goias
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre_Porto Alegre
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Botucatu
state: Sao Paulo
city: São José do Rio Preto
country: Brazil
facility: CIP Centro Integrado de Pesquisas do Hospital de Base
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Assoc. Paulista para o Desenvolvimento da Medicina - UNIFESP
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Departamento de Gastroenterologia - HCFMUSP
state: Sao Paulo
city: Barretos
country: Brazil
facility: Fundação Pio XII
state: São Paulo
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Amor de Barretos
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Clementino Fraga Filho
city: São Paulo
country: Brazil
facility: Rocco e Nazato Servicos Medicos LTDA
city: Sofia
country: Bulgaria
facility: "Acibadem City Clinic UMHAT Tokuda"
city: Sofia
country: Bulgaria
facility: "Diagnostic - Consulting Center Aleksandrovska" EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", Clinic of Gastroenterology
city: Sofia
country: Bulgaria
facility: "UMHAT "Tsaritsa Yoanna-ISUL"" EAD, Gastroenterology clinic
city: Sofia
country: Bulgaria
facility: "DCC XX - Sofia" EOOD
city: Sofia
country: Bulgaria
facility: "UMHAT "Sveta Anna" Sofia" AD
city: Sofia
country: Bulgaria
facility: Medical Center Synexus Sofia
city: Varna
country: Bulgaria
facility: UMHAT "Sveta Marina"
city: Calgary
country: Canada
facility: University of Calgary Liver Unit-(HMRC)
state: Alberta
city: Vancouver
country: Canada
facility: GI Research Inst Foundation
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Hlth Halifax
state: Nova Scotia
city: London
country: Canada
facility: London Hlth Sci Ctr- Univ Camp
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Vaughan
country: Canada
facility: TDDA Specialty Research
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Sherbrooke
country: Canada
facility: Hospital Fleurimont / CIUSS
state: Quebec
city: Terrebonne
country: Canada
facility: Ctr de Med Metab de Lanaudiere
state: Quebec
city: Beijing
country: China
facility: Beijing Ditan Hospital Capital Medical University-Hepatology
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital-(White Pagoda Temple Area)-Hepatopathy
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University-Endocrinology
state: Beijing
city: Beijing
country: China
facility: Beijing You'an Hospital, Capital Medical University-Hepatology center
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital-Hepatology
state: Beijing
city: Chongqing
country: China
facility: Three Gorges Hospital Affiliated to Chongqing University-Endocrinology
state: Chongqing
city: Foshan
country: China
facility: The First People's Hospital of Foshan-Infectious Disease
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First people's Hospital-Gastroenterology
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University-Infectious Diseases
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-sen University-Infectious
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University-Hepatology
state: Hebei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital-Hepatology
state: Hunan
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: THE Affiliated Hospital of Xuzhou Medical University（East）-Infectious Diseases
state: Jiangsu
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University-Hepatic-biliary-pancrestic Medicine
state: Jilin
city: Yinchuan
country: China
facility: General Hosp of Ningxia Medical University,Infectious Depart
state: Ningxia
city: Ji'nan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital-Infectious Diseases
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital (Group)-Infectious Diseases
state: Shandong
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine Renji Hospital-Gastroenterology
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital Affiliate to The Shanghai Jiaotong University-Infectious Diseases
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital Affiliate to The Shanghai Jiaotong Universit
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital-Infection Disease
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital Sichuan University-Infectious Diseases
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Third Central Hospital-Gastroenterology
state: Tianjin
city: Wenzhou
country: China
facility: The First Affiliated Hospital of WMU
state: Zhejiang
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital-Hepatology
city: Hangzhou
country: China
facility: Zhejiang Hospital-Infectious Diseases
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Shenzhen
country: China
facility: The Third People's Hospital of Shenzhen-Hepatology
city: Shenzhen
country: China
facility: The Third People's Hospital of Shenzhen
city: Tianjin
country: China
facility: Tianjin Second People's Hospital-Liver Disease Department III
city: Osijek
country: Croatia
facility: Klinicki bolnicki centar Osijek
city: Rijeka
country: Croatia
facility: KBC Rijeka, Zavod za gastroenterologiju
city: Split
country: Croatia
facility: KBC Split/ Firule/ Gastroenterologija
city: Zagreb
country: Croatia
facility: KB Dubrava, Zavod za gastroenterologiju
city: Zagreb
country: Croatia
facility: Klinički bolnički centar Zagreb, Zavod za gastroenterologiju
city: Liberec
country: Czechia
facility: Krajská nemocice Liberec, a.s
city: Liberec
country: Czechia
facility: Krajská nemocice Liberec, a.s
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen - Lochotin
city: Plzeň
country: Czechia
facility: Researchsite s.r.o.
city: Prague 2
country: Czechia
facility: Vseobecna Fakultni nemocnice v Praze
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital Skejby Mave-Tarm
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital - Gastroenheden
city: København NV
country: Denmark
facility: Abdominal Center K, Research Unit
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Angers
country: France
facility: Centre Hospitalier Universitaire D'Angers-1
city: Clichy
country: France
facility: Ap-Hp-Hopital Beaujon
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille-Hopital Claude Huriez
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice-Hopital de L'Archet 2
city: Paris
country: France
facility: Aphp-Hopital La Pitie Salpetriere-4
city: Paris
country: France
facility: Ap-Hp-Hopital Cochin
city: Leipzig
country: Germany
facility: Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig - Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes-Gutenberg-Universität Mainz - Hepatologie
city: Athens
country: Greece
facility: Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
city: Goudi, Athens
country: Greece
facility: General Hospital of Athens "LAIKO"
city: Thessaloniki
country: Greece
facility: AHEPA General University Hospital
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "Ippokrateio"
city: Secunderabad
country: India
facility: Yashoda Hospital
state: Andhra Pradesh
city: Surat
country: India
facility: Surat Institute of Digestive Science
state: Gujarat
city: Mangalore
country: India
facility: Kasturba Medical College Hospitals (KMC Hospitals), Mangalore
state: Karnataka
city: Mumbai
country: India
facility: Gleneagles Hospital, Super-speciality and Transplant Centre, Parel
state: Maharashtra
city: Mumbai
country: India
facility: Seth GS medical college and KEM Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Midas Multispeciality Hospital
state: Maharashtra
city: Delhi
country: India
facility: All India Institute of medical Sciences
state: New Delhi
city: Ghitorni
country: India
facility: Institute of liver and Biliary Sciences
state: New Delhi
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education & Research_Chandigarh
state: Punjab
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital
state: Punjab
city: Mohali
country: India
facility: Fortis Heart Institute and Multispeciality Hospital
state: Punjab
city: Jaipur
country: India
facility: S.R.Kalla Memorial Gastro & General Hospital
state: Rajasthan
city: Jaipur
country: India
facility: SMS Super speciality Hospital, Department of Gastroenterology
state: Rajasthan
city: Dublin
country: Ireland
facility: Hepatology St James's
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Haifa
country: Israel
facility: Carmel Medical Center Liver Unit
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Liver Unit, Hadassah Medical Center
city: Petah-Tikva
country: Israel
facility: Liver Institute, Rabin Medical Center, Beilinson Campuse
city: Ramat-Gan
country: Israel
facility: The Chaim Sheba Medical Center Liver Diseases Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center Liver Unit
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero-Universitaria Renato Dulbecco
state: Cz
city: Palermo
country: Italy
facility: AOUP Giaccone Palermo
state: Sicilia
city: Bologna
country: Italy
facility: Azieda Ospedaliero-Universitaria, Policlinico S. Orsola-Malp
city: Milano
country: Italy
facility: Osp Magg Policlinico Centro Malattie metaboliche del Fegato
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Rome
country: Italy
facility: Policlinico Università Campus Biomedico di Roma
city: Torino
country: Italy
facility: Città della salute e della scienza - university of Torino
city: Bunkyo-ku, Tokyo
country: Japan
facility: Juntendo University Hospital, Gastroenterology
city: Bunkyo-ku, Tokyo
country: Japan
facility: The University of Tokyo Hospital, Gastroenterology
city: Fukui-shi, Fukui
country: Japan
facility: Fukui-ken Saiseikai Hospital, Internal Medicine
city: Fukushima
country: Japan
facility: Hoshi General Hospital_Gastroenterology
city: Gifu
country: Japan
facility: Gifu Municipal Hospital_Hepatology
city: Gifu
country: Japan
facility: Ogaki Municipal Hospital_Gastroenterology and Hepatology
city: Hamamatsu-shi, Shizuoka
country: Japan
facility: Hamamatsu University Hospital
city: Hatsukaichi-shi, Hiroshima
country: Japan
facility: JA Hiroshima General Hospital
city: Hiroshima-shi, Hiroshima
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hosp.
city: Hiroshima-shi, Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Izunokuni-shi, Shizuoka
country: Japan
facility: Juntendo University Shizuoka Hospital
city: Kagoshima-shi, Kagoshima
country: Japan
facility: Kagoshima University Hospital, Gastroenterology
city: Kamigyo-ku, Kyoto
country: Japan
facility: University Hospital Kyoto Prefectual University of Medicine
city: Kanazawa-shi, Ishikawa
country: Japan
facility: Kanazawa University Hospital
city: Kashihara-shi, Nara
country: Japan
facility: Nara Medical University Hospital_Kashihara-shi, Nara
city: Kawasaki-shi, Kanagawa
country: Japan
facility: St. Marianna University School of Medicine Hospital
city: Kumamoto-shi, Kumamoto
country: Japan
facility: Kumamoto Shinto General Hospital
city: Minato-ku, Tokyo
country: Japan
facility: Toranomon Hospital, Hepatology
city: Musashino-shi, Tokyo
country: Japan
facility: Japanese Red Cross Musashino Hospital
city: Nagakute-shi, Aichi
country: Japan
facility: Aichi Medical University Hospital
city: Nakagamigun, Okinawa
country: Japan
facility: Heartlife Hospital
city: Nara-shi, Nara
country: Japan
facility: Nara City Hospital, Gastroenterology and Hepatology
city: Nishinomiya-shi, Hyogo
country: Japan
facility: Hyogo Medical University Hospital_Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine
city: Oita-shi, Oita
country: Japan
facility: Oita Cardiovascular Hospital
city: Okayama-shi, Okayama
country: Japan
facility: Kawasaki Medical School General Medical Center
city: Osaka-shi, Osaka
country: Japan
facility: Osaka Metropolitan University Hospital, Department of Hepatology
city: Osaka
country: Japan
facility: Japan Organization of Occupational Health and Safety Osaka Rosai Hospital_Gastroenterology
city: Otsu-shi, Shiga
country: Japan
facility: Otsu City Hospital, Gastroenterological Medicine
city: Saga-shi, Saga
country: Japan
facility: Saga University Hospital_Liver Center
city: Sapporo-shi, Hokkaido
country: Japan
facility: Japan Community Health care Organization Hokkaido Hospital
city: Sendai-shi, Miyagi
country: Japan
facility: Sendai Kousei Hospital
city: Shinjuku-ku, Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Suita-shi, Osaka
country: Japan
facility: Saiseikai Suita Hospital, Gastroenterology
city: Takamatsu-shi, Kagawa
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Takasaki-shi, Gunma
country: Japan
facility: National Hospital Organization Takasaki General Medical Ctr.
city: Tokyo
country: Japan
facility: Nihon University Itabashi Hospital
city: Toon-shi, Ehime
country: Japan
facility: Ehime University Hospital
city: Wakayama-shi, Wakayama
country: Japan
facility: Saiseikai Wakayama Hospital
city: Yokohama-shi, Kanagawa
country: Japan
facility: Yokohama City University Hospital, Gastrointestinal Medicine
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam Univ. Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Gangwon-do
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: SoonChunHyang University Hospital Bucheon
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Kota Bharu
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelantan
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
city: Acapulco de Juarez
country: Mexico
facility: Centro de Investigacion Clinica del Pacifico, S.A. de C.V.
state: Guerrero
city: Guadalajara
country: Mexico
facility: Centro de Investigación Médico Biológica y Terapia
state: Jalisco
city: Ciudad de México
country: Mexico
facility: Centro de Investigación y Gastroenterología, S.C.
state: México, D.F.
city: San Pedro Garza Garcia
country: Mexico
facility: Servicios de Oncologia Medica Integral S.A de C.V (ONCARE)
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Investigaciones Médicas Cisneros, S.C.
state: Nuevo León
city: Culiacan
country: Mexico
facility: Hospital Angeles de Culiacan
state: Sinaloa
city: Merida
country: Mexico
facility: Medical Care and Research S. A de C.V
state: Yucatan
city: Mexico
country: Mexico
facility: Centro de Investigación y Gastroenterología_ Hospital Angeles Universidad
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Gjettum
country: Norway
facility: Bærum sykehus
city: Oslo
country: Norway
facility: Oslo universitetssykehus, Ullevål
city: Mysłowice
country: Poland
facility: ID Clinic Arkadiusz Pisula
state: Malopolskie
city: Bydgoszcz
country: Poland
facility: Gizinscy Centrum Medyczne
city: Warszawa
country: Poland
facility: BodyClinic
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych
city: Wrocław
country: Poland
facility: FutureMeds Sp. z o.o.
city: Staszow
country: Poland
facility: Ko-Med Centra Kliniczne Staszow
state: Świętokrzyskie
city: Staszow
country: Poland
facility: Velocity Nova Sp. z o.o.
state: Świętokrzyskie
city: Senhora Da Hora, Matosinhos
country: Portugal
facility: Unidade Local De Saude De Matosinhos E.P.E.
state: Matosinhos
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
city: Almada
country: Portugal
facility: Unidade Local De Saude De Almada-Seixal E.P.E.
city: Braga
country: Portugal
facility: Hospital de Braga
city: Guarda
country: Portugal
facility: Unidade Local De Saude Da Guarda E.P.E. - Hospital Sousa Martins
city: Lisboa
country: Portugal
facility: APDP - Associação Protectora dos Diabéticos de Portugal
city: Lisboa
country: Portugal
facility: Unidade Local De Saude De Santa Maria E.P.E.
city: Porto
country: Portugal
facility: Unidade Local de Saúde de Santo António, E.P.E
city: Viana do Castelo
country: Portugal
facility: Unidade Local de Saúde do Alto Minho E.P.E. - Viana do Castelo
city: Vila Nova de Gaia
country: Portugal
facility: Hospital Luz Arrabida, S.A.
city: Vila Nova de Gaia
country: Portugal
facility: Unidade Local De Saude De Gaia/Espinho E.P.E.
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research
city: Galati
country: Romania
facility: SC Diamed Obesity SRL
city: Satu Mare
country: Romania
facility: Spital Judetean De Urgenta Satu Mare
city: Arkhangelsk
country: Russian Federation
facility: Volosevich First City Clinical Hospital
city: Kazan
country: Russian Federation
facility: Kazan Federal University
city: Moscow
country: Russian Federation
facility: Friendship University of Russia
city: Novosibirsk
country: Russian Federation
facility: Limited Law Company "Healthy Family" Medicine Center"
city: Saint Petersburg
country: Russian Federation
facility: Joint Stock Company "Polyclinic Complex"
city: Saint-Petersburg
country: Russian Federation
facility: Limited Liability Company "Energiya Zdoroviya"
city: Saint-Petersburg
country: Russian Federation
facility: North-Western State Medical Univer. based on Med-Prof Center
city: Saint-Petersburg
country: Russian Federation
facility: Consultative & Diagnostic Center with a Outpatient Hospital
city: Ulianovsk
country: Russian Federation
facility: Ulianovsk Regional Clinical Hospital
city: Yoshkar-Ola
country: Russian Federation
facility: Polyclinic #2 in Yoshkar-Ola
city: Novi Sad
country: Serbia
facility: Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
state: Vojvodina
city: Belgrade
country: Serbia
facility: Clinic for gastroenterology and hepatology
city: Belgrade
country: Serbia
facility: Clinical-hospital centre Zvezdara
city: Singapore
country: Singapore
facility: National University Hospital_TBD
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Bratislava
country: Slovakia
facility: Nemocnica akademika L. Derera, UNB
city: Bratislava
country: Slovakia
facility: MEDISPEKTRUM s.r.o.
city: Port Elizabeth
country: South Africa
facility: Phoenix Pharma
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Hospital
state: Gauteng
city: Johannesburg
country: South Africa
facility: WITS Clinical Research
state: Gauteng
city: Lenasia
country: South Africa
facility: Lenasia Clinical Trial Centre
state: Gauteng
city: Durban
country: South Africa
facility: Maxwell Centre
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: Tiervlei Trial Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: Dr Rajabally's Practice
state: Western Cape
city: Johannesburg
country: South Africa
facility: Wits Health Consortium
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra - Hospital de Montecelo
state: Galicia
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra - Hospital de Montecelo
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico de Valladolid
city: Bern
country: Switzerland
facility: Universitätsklinik für Viszerale Chirurgie und Medizin
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Olten
country: Switzerland
facility: Kantonsspital Olten
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Chiayi City
country: Taiwan
facility: Ditmanson Medical Foundation Chia-Yi Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei city
country: Taiwan
facility: Taipei-Veterans General Hospital - Dept of Gastrointestinal
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Adana
country: Turkey
facility: T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
city: Ankara
country: Turkey
facility: Ankara Universitesi Tıp Fakultesi Gastroenteroloji Bilim Da
city: Ankara
country: Turkey
facility: Ankara Sehir Hastanesi,Gastroenteroloji Klinigi
city: Bursa
country: Turkey
facility: Uludag Universitesi Tıp Fakultesi-Gastroenteroloji
city: Istanbul
country: Turkey
facility: Koc Universitesi Hastanesi-Gastroenteroloji
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi-Gastroe
city: Istanbul
country: Turkey
facility: Marmara Univ. Pendik Gastroenterology
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi, Gastroenteroloji
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tıp Fakültesi Gastroenteroloji ve Hepat
city: Mersin
country: Turkey
facility: Mersin Universitesi Tip Fakultesi Gastroenteroloji Bilim Dal
city: Birmingham
country: United Kingdom
facility: New Queen Elizabeth Hospital Birmingham
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon University Healthcare NHS Foundation Trust
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary_Hull
city: Ipswich
country: United Kingdom
facility: The Diabetes Centre
city: Leeds
country: United Kingdom
facility: St. James University Hospital
city: London
country: United Kingdom
facility: Royal Free - Immunity & Transplantation
city: London
country: United Kingdom
facility: Chelsea & Westminster Hospital
city: London
country: United Kingdom
facility: Imperial College London
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital, Newcastle
city: Newcastle-Upon Tyne
country: United Kingdom
facility: Freeman Hospital, Newcastle
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Swansea
country: United Kingdom
facility: Joint Clinical Research Facility - Swansea
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References:
citation: 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.