LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis
3 other identifiers
interventional
1,590
35 countries
438
Brief Summary
This study is open to adults who are at least 18 years old and have:
- A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or
- A confirmed liver disease called metabolic-associated steatohepatitis (MASH)
- BMI of 27 kg/m2 or more or
- 25 kg/m2 or more if the participant is Asian. People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2024
Longer than P75 for phase_3
438 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2024
CompletedFirst Posted
Study publicly available on registry
October 9, 2024
CompletedStudy Start
First participant enrolled
November 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 5, 2029
April 29, 2026
April 1, 2026
4.6 years
October 8, 2024
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH
MELD = model of end-stage liver disease CSPH = Clinically significant portal hypertension
up to 4.5 years.
Secondary Outcomes (13)
Key secondary endpoint: Absolute change from baseline in enhanced liver fibrosis (ELF) score
At baseline and at Week 76.
Key secondary endpoint: Percentage change from baseline in body weight
At baseline and at Week 76.
Key secondary endpoint: Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) (%) in participants with type 2 diabetes mellitus (T2DM) at baseline
At baseline and at Week 76.
Key secondary endpoint: Absolute change from baseline in liver stiffness (kPa) in FibroScan® vibration-controlled transient elastography (VCTE)
At baseline and at Week 76.
Percentage change from baseline in liver stiffness in FibroScan® VCTE
At baseline and at Week 76.
- +8 more secondary outcomes
Study Arms (2)
Survodutide
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Subcutaneous injection, pre-filled syringe
Eligibility Criteria
You may qualify if:
- Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \>18 years
- Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)
- Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.
You may not qualify if:
- Current or history (\<5 years) of significant alcohol consumption, defined as an average of \>140 g/week in female patients and \>210 g/week in male patients, for a period of \>3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.
- Model of end-stage liver Disease (MELD) score \>12 due to liver disease
- History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:
- Portal hypertension-related upper gastrointestinal (GI) bleeding
- Ascites
- Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria
- Any of the following lab test result at screening
- Albumin below \<3.5 g/dL (\<35.0 g/L)
- International normalised ratio (INR) \>1.3 unless due to therapeutic anticoagulants
- Total bilirubin (TBL) \>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is \<20% of TBL.
- Alkaline phosphatase \>1.5x ULN
- PLT \<100,000/µL (\<100 GI/L)
- History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis
- Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection
- Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (443)
The Institute for Liver Health II DBA Arizona Clinical Trials
Peoria, Arizona, 85381, United States
Scottsdale Medical Specialists, Ltd
Scottsdale, Arizona, 85258, United States
Adobe Clinical Research, LLC
Tucson, Arizona, 85712, United States
Arizona Liver Health - Tucson
Tucson, Arizona, 85712, United States
Del Sol Research Management, LLC
Tucson, Arizona, 85715, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
Velocity Clinical Research-Chula Vista
Chula Vista, California, 91911, United States
Southern California Research Center
Coronado, California, 92118, United States
ARK Clinical Research
Fountain Valley, California, 92708, United States
Velocity Clinical Research-Huntington Park
Huntington Park, California, 90255, United States
310 Clinical Research
Inglewood, California, 90301, United States
Velocity Clinical Research, San Diego
La Mesa, California, 91942, United States
Om Research, LLC
Lancaster, California, 93534, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
Clinnova Research Solutions
Orange, California, 92868, United States
Fomat Medical Research
Oxnard, California, 93030, United States
Cadena Care Institute, Llc
Poway, California, 92064, United States
Ficramed Research Institute
Poway, California, 92064, United States
Inland Empire Clinical Trials, LLC
Rialto, California, 92377, United States
Metro Clinical Trials
San Bernardino, California, 92404, United States
Acclaim Clinical Research
San Diego, California, 92120, United States
Future Innovative Treatments
Colorado Springs, Colorado, 80907, United States
South Denver Gastroenterology PC
Englewood, Colorado, 80113, United States
Connecticut Gastroenterology Clinical Research Foundation
Bristol, Connecticut, 06010, United States
Synergy Healthcare
Brandon, Florida, 33511, United States
Access research Institute
Brooksville, Florida, 34613, United States
Hi Tech and Global Research, LLC
Coral Gables, Florida, 33134, United States
Top Medical Research, Inc
Cutler Bay, Florida, 33189, United States
Covenant Metabolic Specialists, LLC - Fort Myers
Fort Myers, Florida, 33912, United States
Neoclinical Research
Hialeah, Florida, 33016, United States
Evolution Clinical Trials
Hialeah Gardens, Florida, 33016, United States
Global Research Associates
Homestead, Florida, 33030, United States
Lake Center for Clinical Research
Lady Lake, Florida, 32159, United States
Research Associates of South Florida, LLC
Miami, Florida, 33134, United States
Optimus U Corporation-Miami-69452
Miami, Florida, 33135, United States
Schiff Center Liver Diseases
Miami, Florida, 33136, United States
BioMed Research & Medical Center
Miami, Florida, 33156, United States
MplusM - Century Research
Miami, Florida, 33173, United States
ECIR Miami Holdings LLC dba IMIC
Miami, Florida, 33176, United States
Entrust Clinical Research
Miami, Florida, 33176, United States
Floridian Clinical Research
Miami Lakes, Florida, 33016, United States
Advanced Research Institute
New Port Richey, Florida, 34653, United States
Charter Research
Orlando, Florida, 32803, United States
Omega Research Orlando, LLC
Orlando, Florida, 32808, United States
Endoscopic Research, Inc
Orlando, Florida, 32828, United States
Innovation Medical Research Center
Palmetto Bay, Florida, 33157, United States
MplusM - Best Choice Medical and Research Service
Pembroke Pines, Florida, 33024, United States
Covenant Metabolic Specialist, LLC - Riverview
Riverview, Florida, 33578, United States
Global Clinical Professionals
St. Petersburg, Florida, 33705, United States
Synergy Healthcare
St. Petersburg, Florida, 33705, United States
International Center for Research
Tampa, Florida, 33614, United States
Charter Research
The Villages, Florida, 32162, United States
Covenant Metabolic Specialists, LLC - University Park
University Park, Florida, 34201, United States
Conquest Research
Winter Park, Florida, 32789, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33542, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201, United States
EmVenio Research Center at Prime Healthcare - Riverdale
Riverdale, Georgia, 30274, United States
ASHA Clinical Research - Munster, LLC
Hammond, Indiana, 46324, United States
Digestive Research Alliance of Michiana
South Bend, Indiana, 46635, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Delta Research Partners, LLC
Monroe, Louisiana, 71201, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Clinical Research Institute of Michigan, LLC
Clinton Township, Michigan, 48038, United States
West Michigan Clinical Research Center
Wyoming, Michigan, 49519, United States
MNGI Digestive Health, PA
Minneapolis, Minnesota, 55413, United States
ObjectiveHealth-GI Associates Research
Columbia, Missouri, 65201, United States
Kansas City Research Institute
Kansas City, Missouri, 64131, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Jubilee Clinical Research, Inc
Las Vegas, Nevada, 89106, United States
Excel Clinical Research
Las Vegas, Nevada, 89109, United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121, United States
IMA Clinical Research-Warren-69742
Warren Township, New Jersey, 07059, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Basil Clinical
Laurelton, New York, 11413, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Coastal Research Institute, LLC
Fayetteville, North Carolina, 28304, United States
Carolina Researche
Greenville, North Carolina, 27834, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
ObjectiveHealth-DSI Research - Springboro, LLC
Springboro, Ohio, 45066, United States
Northshore Gastroenterology Research
Westlake, Ohio, 44145, United States
Options Health Research
Tulsa, Oklahoma, 74104, United States
US Digestive Health
Flourtown, Pennsylvania, 19031, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
US Digestive Health
Lancaster, Pennsylvania, 17601, United States
US Digestive Health
Wyomissing, Pennsylvania, 19610, United States
ObjectiveHealth-Columbia Digestive Health Research
Columbia, South Carolina, 29204, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Premier Medical Group
Clarksville, Tennessee, 37040, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
IMA Clinical Research Austin
Austin, Texas, 78745, United States
American Research Corporation - Austin
Austin, Texas, 78757, United States
Pinnacle Clinical Research - Austin
Austin, Texas, 78757, United States
Velocity Clinical Research, Austin
Austin, Texas, 78759, United States
Pinnacle Clinical Research, LLC
Bellaire, Texas, 77401, United States
South Texas Research Institute - Brownsville
Brownsville, Texas, 78520, United States
North Texas Research Institute - Dallas
Dallas, Texas, 75150, United States
Zenos Clinical Research
Dallas, Texas, 75230, United States
GI Alliance Research - Dallas
Dallas, Texas, 75246, United States
Soma Clinical Trials
Denison, Texas, 75020, United States
EmVenio Research Center at Prime Healthcare - Farmers Branch
Garden City, Texas, 48135, United States
DHAT Reseach Institute
Garland, Texas, 75044, United States
Pinnacle Clinical Research, LLC
Georgetown, Texas, 78626, United States
Ben Taub General Hospital
Houston, Texas, 77030-1608, United States
Biopharma Informatic, Inc. Research Center
Houston, Texas, 77084, United States
Research Physicians Network
Houston, Texas, 77089, United States
Epic Clinical Research
Lewisville, Texas, 75057, United States
GI Alliance Research - Mansfield
Mansfield, Texas, 76063, United States
Biopharma Informatic LLC
McAllen, Texas, 78503, United States
Centex Studies, Inc.
McAllen, Texas, 78504, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215, United States
Brooke Army Medical Center
San Antonio, Texas, 78219, United States
HASresearch
San Antonio, Texas, 78240, United States
Velocity Clinical Research, Waco
Waco, Texas, 76710, United States
Objective Health-Digestive Research of Central Texas
Waco, Texas, 76712, United States
ObjectiveHealth-Digestive Health Research of North Texas
Wichita Falls, Texas, 76301, United States
GI Select Health Research LLC
Richmond, Virginia, 23236, United States
Velocity Clinical Research, Seattle
Seattle, Washington, 98105, United States
Velocity Clinical Research-Spokane-69716
Spokane, Washington, 99218, United States
CIPREC
Buenos Aires, 1061, Argentina
IDIM - Instituto de Diagnostico e Investigaciones Metabolicas
Buenos Aires, C1012AAR, Argentina
Buenos Aires Macula S.A.
Buenos Aires, C1061AAE, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB, Argentina
Glenny Corp - Centro Médico Saavedra
Buenos Aires, C1430CKE, Argentina
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
C.a.b.a, C1056ABJ, Argentina
Hospital General de Agudos Dr. J. M. Ramos Mejia
Ciudad Autonoma Buenos Aires, C1221ADC, Argentina
Hospital Universitario Austral
Pilar, B1629ODT, Argentina
DIM Clinica Privada
Ramos Mejía, 1704, Argentina
Hospital El Cruce
San Juan Bautista, B1888, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Medical University Graz
Graz, 8036, Austria
Ordensklinikum Linz GmbH
Linz, 4010, Austria
AKH - Medical University of Vienna
Vienna, 1090, Austria
Hospital Hietzing
Vienna, 1130, Austria
Klinikum Wels - Grieskirchen GmbH
Wels, 4600, Austria
ULB Hopital Erasme
Brussels, 1070, Belgium
Edegem - UNIV UZ Antwerpen
Edegem, 2650, Belgium
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
Centre Hospitalier Universitaire de Liège
Liège, 4000, Belgium
Universidade Federal do Rio de Janeiro
Barra, 21941-617, Brazil
Hospital Universitário João de Barros Barreto
Belém, 66073-005, Brazil
Hospital das Clinicas da Universidade Federal de Minas Gerais (HCUFMG)
Belo Horizonte, 30130-100, Brazil
Universidade Estadual Paulista 'Julio De Mesquita Filho'
Botucatu, 18618-970, Brazil
Hospital das Clinicas da Faculdade de Medicina da USP
Cerqueira César, 05403-000, Brazil
Hospitalar Moinhos de Vento
Porto Alegre, 90035-001, Brazil
Universidade Federal do Rio Grande do Sul
Porto Alegre, 90035-903, Brazil
Hospital de Base - Fac Med de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000, Brazil
Rocco E Nazato Servicos Medicos LTDA
Vila Nova Conceição, 04543-011, Brazil
MHAT Sv. Ivan Rilski EOOD
Gorna Oryahovitsa, 5100, Bulgaria
Multi-profile Hospital For Active Treatment-Uni Hospital Ltd.
Panagyurishte, 4500, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia, 1407, Bulgaria
Diagnostic Consultative Center Alexandrovska
Sofia, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
Sofia, 1431, Bulgaria
Medical Military Academy MHAT Sofia
Sofia, 1606, Bulgaria
Medical Center New Rehabilitation Center EOOD
Stara Zagora, 6003, Bulgaria
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
University of British Columbia
Vancouver, British Columbia, V5Z 1M9, Canada
Viable Clinical Research
Bridgewater, Nova Scotia, B4N 3N2, Canada
Toronto Liver Centre
Toronto, Ontario, M6H 3M1, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, H3H 2R9, Canada
Diex Recherche Québec
Québec, G1N 4V3, Canada
Edificio Fleming
La Serena, 1710209, Chile
Centro de Investigaciones Médicas UC
Santiago, 8330024, Chile
Centro de Investigaciones Clinicas Viña del Mar
Viña del Mar, 2520997, Chile
Beijing Ditan Hospital Capital Medical University
Beijing, 100015, China
Beijing Tsinghua Changgung Hospital
Beijing, 100044, China
Peking University People's Hospital
Beijing, 100044, China
Beijing Friendship Hospital
Beijing, 100050, China
Beijing Youan Hospital, Capital Medical University
Beijing, 100069, China
The First Hospital of Jilin University
Changchun, 130021, China
Hunan Provincial People's Hospital
Changsha, 410005, China
Changzhou Third People's Hospital
Changzhou Shi, 214442, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Chongqing Three Gorges Central Hospital
Chongqing, 404000, China
The First People's Hospital of Foshan
Foshan, 528000, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, 350005, China
Guangzhou Eighth People's Hospital,Guangzhou Medical University
Guangzhou, 510000, China
Guangzhou First People's Hospital
Guangzhou, 510013, China
NanFang Hosptial
Guangzhou, 510515, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003, China
Zhejiang Hospital
Hangzhou, 310013, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, 310015, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016, China
The First hospital of Jiaxing
Jiaxing, 314001, China
First People's hospital of Yunann Province
Kunming, 650032, China
Liaocheng People's Hospital
Liaocheng, 252000, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471003, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006, China
The Second Hospital of Nanjing
Nanjing, 210003, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Nanjing Jiangning Hospital
Nanjing, 211100, China
Ningbo Second Hospital
Ningbo, 315010, China
General Hospital of Ningxia Medical University
Ningxia, 750004, China
Pingxiang People's Hospital
Pingxiang, 337000, China
Qingdao Municipal Hospital
Qingdao, 266001, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025, China
Shanghai General Hospital
Shanghai, 200080, China
Shanghai East Hospital
Shanghai, 200120, China
Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
Shanghai, 200127, China
Shanghai Public Health Clinical Center
Shanghai, 201508, China
Renmin Hospital of Wuhan University
Shanghai, 430060, China
The Sixth People's Hospital of Shenyang
Shenyang, 110006, China
The Fifth People's Hospital of Suzhou
Suzhou, 215007, China
Tianjin Third Central Hospital
Tianjin, 300170, China
Tianjin Second People's Hospital
Tianjin, 300192, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Second Affiliated Hospital of Xi'an JiaoTong University
Xi'an, 710004, China
First Affiliated Hospital of Xi'an JiaoTong University
Xi'an, 710061, China
Sixth People's Hospital of Zhengzhou
Zhengzhou, 450005, China
The Third People's Hospital of Zhenjiang
Zhenjiang, 212021, China
Krajska nemocnice Liberec a.s.
Liberec, 460 01, Czechia
Research Site s.r.o.
Pilsen, 301 00, Czechia
General Faculty Hospital, Prague
Prague, 128 08, Czechia
CHU Amiens-Picardie
Amiens, 80054, France
Centre Hospitalier Universitaire D'Angers
Angers, 49100, France
Hôpital Beaujon
Clichy, 92110, France
HOP Dijon-Bourgogne
Côte-d'Or, 21000, France
Hôpital Henri Mondor
Créteil, 94000, France
Centre Hospitalier De Versailles
Le Chesnay, 78150, France
Hôpital Claude Huriez
Lille, 59000, France
Hopital De La Croix-Rousse
Lyon, 69004, France
Hôpital de l'Archet
Nice, 06200, France
Hopitaux Universitaires Pitié-Salpétrière
Paris, 75013, France
Hôpital Cochin
Paris, 75014, France
Centre Hospitalier Universitaire De Bordeaux
Pessac, 33600, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Hôpital Rangueil - CHU de Toulouse
Toulouse, 31059, France
Ltd "Health"
Batumi, 6010, Georgia
ISR-GEO Med Res Clin Healthycore
Tbilisi, 0112, Georgia
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
Bochum, 44892, Germany
Universitätsklinikum Köln (AöR)
Cologne, 50937, Germany
Technische Universität Dresden
Dresden, 01307, Germany
Universitätsklinikum Frankfurt
Frankfurt, 69590, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Universität des Saarlandes
Homburg, 66421, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538, Germany
Otto-von-Guericke-Universität Magdeburg
Magdeburg, 39120, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Universitätsklinikum Mannheim GmbH
Mannheim, 68167, Germany
Universitätsklinikum Münster
Münster, 49129, Germany
St. Josefs-Hospital Wiesbaden
Wiesbaden, 65189, Germany
Universitätsklinikum Würzburg AÖR
Würzburg, 97080, Germany
Dr. Rethy Pal Hospital
Békéscsaba, 5600, Hungary
Obudai Egeszegugyi Centrum
Budapest, 1036, Hungary
Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika
Budapest, 1082, Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, 1097, Hungary
Aryav Superspeciality Hospital
Ahemdabad, 380060, India
Post Graduate Institute of Medical Education and Research
Chandigarh, 14209-1120, India
Osmania Medical College & Hospital
Hyderabad, Afzalgunj, 500012, India
SR Kalla Memorial Hospital
Jaipur, 302001, India
ManglamPlus Medicity Hospital
Jaipur, 302020, India
Atharva Multispecialty Hospital and research Centre
Lucknow, 226003, India
Midas Multispeciality Hospital Pvt. Ltd.
Nagpur, 440010, India
Insitute of Liver and Billiary Sciences
New Delhi, 110 070, India
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak, 124001, India
Yashoda Hospitals - Secunderabad
Secunderabad, 500003, India
Surat Institute of Digestive Sciences
Surat, 395002, India
BAPS Pramukh Swami Hospital
Surat, 395009, India
Gujarat Gastro and Vascular Hospital
Surat, 395009, India
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Abbiategrasso, 20122, Italy
Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
Az.Osp. Universitaria "Ospedali Riuniti"
Foggia, 71122, Italy
Università degli Studi di Genova
Modena, 41121, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Fondazione Policlinico Universitario Campus Bio-medico
Rome, 00128, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Universita Degli Studi di Torino
Torino, 10126, Italy
The University of Tokyo Hospital
Bunkyō City, 113-8655, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
Ehime University Hospital
Ehime, Toon, 791-0295, Japan
Fukuiken Saiseikai Hospital
Fukui, Fukui, 918-8503, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563, Japan
Kurume University Hospital
Fukuoka, Kurume, 830-0011, Japan
Gifu Municipal Hospital
Gifu, Gifu, 500-8513, Japan
Ogaki Municipal Hospital
Gifu, Ogaki, 503-8502, Japan
Nagano Municipal Hospital
Hanishina-gun, 381-8551, Japan
Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital
Hiroshima, 730-0052, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Sapporo Kosei General Hospital
Hokkaido, Sapporo, 060-0033, Japan
Japan Community Health Care Organization Hokkaido Hospital
Hokkaido, Sapporo, 062-8618, Japan
Tokyo Medical University Ibaraki Medical Center
Ibaraki, Inashiki-gun, 300-0395, Japan
Tokai University Hospital
Isehara, 259-1193, Japan
Kanazawa University Hospital
Ishikawa, Kanazawa, 920-8641, Japan
Shimane University Hospital
Izumo, 693-8501, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima, 890-8520, Japan
Shin-yurigaoka General Hospital
Kanagawa, Kawasaki, 215-0026, Japan
Kagawa University Hospital
Kita-gun, 761-0793, Japan
Kobe University Hospital
Kobe, 650-0017, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Kumamoto Shinto General Hospital
Kumamoto, Kumamoto, 862-8655, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Kure, 737-0023, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
University of Miyazaki Hospital
Miyazaki, 889-1692, Japan
Japanese Red Cross Musashino Hospital
Musashino, 186-8610, Japan
Shinshu University Hospital
Nagano, Matsumoto, 390-8621, Japan
Nagasaki Medical Center
Nagasaki, Omura, 856-8562, Japan
Nara Medical University Hospital
Nara, Kashihara, 634-8522, Japan
International University of Health and Welfare Narita Hospital
Narita, 286-0105, Japan
Niigata University Medical and Dental Hospital
Niigata, 951-8520, Japan
Hyogo College of Medicine Hospital
Nishinomiya, 663-8501, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Osaka City University Hospital
Osaka, 545-0051, Japan
Oita Cardiovascular Hospital
Ōita, 870-0837, Japan
Saga University Hospital
Saga, 849-8501, Japan
Osaka Rosai Hospital
Sakai, 591-8025, Japan
Seichokai Bell Land General Hospital
Sakai, 599-8247, Japan
Sendai Tokushukai Hospital
Sendai, 981-3116, Japan
Tokyo Medical University Hospital
Shinjuku-ku, 160-0023, Japan
Iwate Medical University Hospital
Shiwa-gun, 028-3695, Japan
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192, Japan
Juntendo University Shizuoka Hospital
Shizuoka, Izunokuni, 410-2295, Japan
The University of Osaka Hospital
Suita, 565-0871, Japan
Suita Hospital
Suita-Shi, 564-0013, Japan
National Hospital Organization Takasaki General Medical Center
Takasaki-shi, 370-0829, Japan
Juntendo University Hospital
Tokyo, 113-8431, Japan
Institute of Science Tokyo Hospital
Tokyo, 113-8519, Japan
Nihon University Itabashi Hospital
Tokyo, 173-8610, Japan
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, 113-8603, Japan
Toranomon Hospital
Tokyo, Minato-ku, 105-8470, Japan
Mie University Hospital
Tsu, 514-8507, Japan
Wakayama Medical University Hospital
Wakayama, 641-8509, Japan
Yokohama City University Hospital
Yokohama, 236-0004, Japan
The Speciality Hospital (TSH)
Amman, 11194, Jordan
Jordan University Hospital
Jordan, 13046, Jordan
Asfendiyarov Kazakh National Medical University
Almaty, 050000, Kazakhstan
Institute of Gastroenterology, Hepatology and Metabolism LLP
Almaty, 050026, Kazakhstan
Hospital Ampang
Ampang, 68000, Malaysia
Hospital Universiti Sains Malaysia
Kota Bharu, 16150, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Queen Elizabeth Hospital
Putrajaya, 0000, Malaysia
Centro de Investigacion Clinica del Pacifico (CICPA)
Acapulco de Juárez, 39670, Mexico
Centro de Investigación y Gastroenterología
Col. Xoco, 03339, Mexico
Instituto de Diabetes, Obesidad y Nutrición S.C.
Cuernavaca, 62250, Mexico
Clinicos Asociados BOCM SC
Mexico City, 03300, Mexico
Centro de Investigación y Gastroenterología
Mexico City, 06700, Mexico
Medical Care and Research
Mérida, 97070, Mexico
Practice Dr Rosa Isela Luna Ceballos
Veracruz, 91910, Mexico
Centro de Alta Especialidad del Estado de Veracruz
Xalapa, 91020, Mexico
Albert SchweitzerZiekenhuis
Dordrecht, 3318 AT, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
Franciscus Gasthuis
Schiedam, 3118 JH, Netherlands
New Zealand Clinical Research (NZCR)
Grafton, Auckland, 1010, New Zealand
Middlemore Hospital
Papatoetoe, Auckland, 2025, New Zealand
Christchurch Hospital
Christchurch, Canterbury, 8140, New Zealand
Waikato Hospital
Hamilton, Waikato Region, 3240, New Zealand
Medical Centre FutureMeds Krakow
Krakow, 31-501, Poland
Santa SP. z o.o
Lodz, 90-302, Poland
FutureMeds Lodz
Lodz, 91-363, Poland
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Lublin, 20-081, Poland
ID Clinic
Mysłowice, 41-400, Poland
FutureMeds Warszawa Centrum
Warsaw, 00-215, Poland
Bodyclinic sp. z o.o. sp.k.
Warsaw, 03-712, Poland
FutureMeds Wroclaw
Wroclaw, 53-673, Poland
EMC Instytut Medyczny S.A. - Wroclaw
Wroclaw, 54-144, Poland
Klinical Investigations Group, LLC
San Juan, 00909, Puerto Rico
Latin Clinical Trial Center
San Juan, 00909, Puerto Rico
FDI Clinical Research
San Juan, 00927, Puerto Rico
Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor"
Cluj-Napoca, 400162, Romania
Spital Judetean De Urgenta Satu Mare
Satu Mare, 440055, Romania
King Faisal Specialist Hospital and Research Center
Riyadh, 11564, Saudi Arabia
King Abdulaziz Medical City, National Guard Health Affairs
Riyadh, 14611, Saudi Arabia
National University Hospital
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Changi General Hospital
Singapore, 529889, Singapore
Practice Dr Naeem Moosa
Johannesburg, 1827, South Africa
Inspired GI Care
Plumstead, 7800, South Africa
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, 14584, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
SMG-SNU Boramae Medical Center
Seoul, 07061, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
Chung-Ang University Hospital
Seoul, 6973, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Puerta de Hierro
Majadahonda, 28222, Spain
Complexo Hospitalario Universitario de Pontevedra
Pontevedra, 36071, Spain
Hospital Clínico de Santiago
Santiago de Compostela, 15706, Spain
Fondazione Epatocentro Ticino
Arzo, 6900, Switzerland
Hopitaux Universitaires de Geneve (HUG)
Geneva, 1205, Switzerland
University Hospital Zurich
Zurich, 8091, Switzerland
Changhua Christian Hospital
Changhua, 50006, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsuing City, 80756, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
Chi Mei Medical Center
Tainan, 71004, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Taipei Medical University Hospital
Taipei, 110301, Taiwan
Taipei Veterans General Hospital
Taipei, 112201, Taiwan
Chang Gung Medical Foundation (CGMF) - Linkou Bran
Taoyuan District, 33305, Taiwan
Hacettepe Universitesi Tip Fakultesi
Ankara, 06230, Turkey (Türkiye)
Gazi Universitesi Tip Fakultesi
Ankara, 06560, Turkey (Türkiye)
Uludag Universitesi Tip Fakultesi
Bursa, 16059, Turkey (Türkiye)
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Fatih, 34093, Turkey (Türkiye)
Koc Universitesi Hastanesi
Istanbul, 34010, Turkey (Türkiye)
Memorial Bahçelievler Hospital
Istanbul, 34180, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Izmir, 35030, Turkey (Türkiye)
Recep Tayyip Erdogan Universitesi Egitim ve Arastirma Hastanesi
Rize, 53020, Turkey (Türkiye)
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
Velocity Clinical Research, Bristol
Bristol, BS82RA, United Kingdom
Frimley Park Hospital
Camberley, GU16 7UJ, United Kingdom
Derby City General Hospital
Derby, DE22 3NE, United Kingdom
Queen Elizabeth Hospital Birmingham
Edgbaston, Birmingham, B15 2WB, United Kingdom
Royal Devon and Exeter Hospital
Exeter, EX2 5AX, United Kingdom
Panthera Biopartners - Glasgow
Glasgow, G51 4TY, United Kingdom
St Luke's Cancer Centre
Guildford, GU2 7XX, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
Aintree University Hospital
Liverpool, L9 7Al, United Kingdom
Royal Free Hospital
London, NW32PF, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Chelsea and Westminster Hospital
London, SW10 9NH, United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, NE4 6BE, United Kingdom
Accellacare North London
Northwood, HA6 2RN, United Kingdom
Accellacare - South London
Orpington, London, BR5 3QG, United Kingdom
Panthera Biopartners - Preston
Preston, PR2 9RB, United Kingdom
Panthera Biopartners - Rochdale
Rochdale, OL11 4AU, United Kingdom
Panthera Biopartners - Sheffield
Sheffield, S2 5FX, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
St George's Hospital
Tooting, London, SW17 0QT, United Kingdom
Panthera Biopartners - York
York, YO24 4LJ, United Kingdom
Related Links
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2024
First Posted
October 9, 2024
Study Start
November 7, 2024
Primary Completion (Estimated)
June 5, 2029
Study Completion (Estimated)
June 5, 2029
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.