RecruitingPhase 3NCT06632444

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis/Metabolic Dysfunction-associated Steatohepatitis (NASH/MASH) and (F2) - (F3) Stage of Liver Fibrosis


Sponsor

Boehringer Ingelheim

Enrollment

1,800 participants

Start Date

Sep 17, 2024

Study Type

INTERVENTIONAL

Summary

This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic 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 MASH and moderate or advanced liver fibrosis improve their liver function. This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving 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. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having 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 and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent
  • Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \[NAS\] ≥4
  • Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used

Exclusion Criteria14

  • Any of the following liver laboratory test abnormalities at screening:
  • Serum AST and/or alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)
  • Platelet count \<140 000/mm\^3 (\<140 GI/L)
  • Alkaline phosphatase \>2x upper limit of normal (ULN)
  • Abnormal synthetic liver function as defined by screening central laboratory evaluation:
  • Albumin below \<3.5 g/dL (35.0 g/L)
  • OR International normalised ratio (INR) of prothrombin time \>1.3
  • OR total serum bilirubin concentration ≥1.5x ULN
  • Any history or evidence of acute or chronic liver disease other than MASH
  • Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy
  • History of or current diagnosis of hepatocellular carcinoma
  • History of or planned liver transplant
  • Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.
  • History of portal hypertension or presence of decompensated liver disease

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Interventions

COMBINATION_PRODUCTSurvodutide

Subcutaneous injection, prefilled syringe

COMBINATION_PRODUCTPlacebo

Subcutaneous injection, prefilled syringe


Locations(526)

University of Alabama at Birmingham

Birmingham, Alabama, United States

The Institute for Liver Health II DBA Arizona Clinical Trials

Peoria, Arizona, United States

Scottsdale Medical Specialists, Ltd

Scottsdale, Arizona, United States

Adobe Clinical Research, LLC

Tucson, Arizona, United States

Arizona Liver Health - Tucson

Tucson, Arizona, United States

Del Sol Research Management, LLC

Tucson, Arizona, United States

Hope Clinical Research

Canoga Park, California, United States

Velocity Clinical Research-Chula Vista

Chula Vista, California, United States

Southern California Research Center

Coronado, California, United States

ARK Clinical Research

Fountain Valley, California, United States

University of California San Francisco

Fresno, California, United States

Velocity Clinical Research-Gardena-69773

Gardena, California, United States

Velocity Clinical Research-Huntington Park

Huntington Park, California, United States

310 Clinical Research

Inglewood, California, United States

Velocity Clinical Research, San Diego

La Mesa, California, United States

Om Research, LLC

Lancaster, California, United States

ARK Clinical Research

Long Beach, California, United States

Velocity Clinical Research, Westlake

Los Angeles, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

Clinnova Research Solutions

Orange, California, United States

Fomat Medical Research

Oxnard, California, United States

California Liver Research Institute

Pasadena, California, United States

Cadena Care Institute, Llc

Poway, California, United States

Ficramed Research Institute

Poway, California, United States

Inland Empire Clinical Trials, LLC

Rialto, California, United States

Metro Clinical Trials

San Bernardino, California, United States

Acclaim Clinical Research

San Diego, California, United States

Medical Associates Research Group, Inc.

San Diego, California, United States

Velocity Clinical Research, Santa Ana

Santa Ana, California, United States

Velocity Clinical Research, Van Nuys

Van Nuys, California, United States

Om Research, LLC

Victorville, California, United States

Future Innovative Treatments

Colorado Springs, Colorado, United States

South Denver Gastroenterology PC

Englewood, Colorado, United States

Connecticut Gastroenterology Clinical Research Foundation

Bristol, Connecticut, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Synergy Healthcare

Brandon, Florida, United States

Access research Institute

Brooksville, Florida, United States

Tampa Bay Medical Research

Clearwater, Florida, United States

K2 Medical Research - Winter Garden

Clermont, Florida, United States

Hi Tech and Global Research, LLC

Coral Gables, Florida, United States

Top Medical Research, Inc

Cutler Bay, Florida, United States

Covenant Metabolic Specialists, LLC - Fort Myers

Fort Myers, Florida, United States

University of Florida

Gainesville, Florida, United States

Neoclinical Research

Hialeah, Florida, United States

Evolution Clinical Trials

Hialeah Gardens, Florida, United States

Global Research Associates

Homestead, Florida, United States

Lake Center for Clinical Research

Lady Lake, Florida, United States

Florida Research Institute

Lakewood Rch, Florida, United States

K2 Medical Research

Maitland, Florida, United States

Research Associates of South Florida, LLC

Miami, Florida, United States

Optimus U Corporation-Miami-69452

Miami, Florida, United States

Schiff Center Liver Diseases

Miami, Florida, United States

BioMed Research & Medical Center

Miami, Florida, United States

ECIR Miami Holdings LLC dba IMIC

Miami, Florida, United States

Entrust Clinical Research

Miami, Florida, United States

Floridian Clinical Research

Miami Lakes, Florida, United States

GI Pros Research

Naples, Florida, United States

Charter Research

Orlando, Florida, United States

K2 Medical Research

Orlando, Florida, United States

Omega Research Orlando, LLC

Orlando, Florida, United States

Endoscopic Research, Inc

Orlando, Florida, United States

Innovation Medical Research Center

Palmetto Bay, Florida, United States

MplusM - Best Choice Medical and Research Service

Pembroke Pines, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Covenant Metabolic Specialist, LLC - Riverview

Riverview, Florida, United States

Global Clinical Professionals

St. Petersburg, Florida, United States

Synergy Healthcare

St. Petersburg, Florida, United States

International Center for Research

Tampa, Florida, United States

Charter Research

The Villages, Florida, United States

Covenant Metabolic Specialists, LLC - University Park

University Park, Florida, United States

Conquest Research

Winter Park, Florida, United States

Florida Medical Clinic, P.A.

Zephyrhills, Florida, United States

Gastroenterology Associates of Central Georgia

Macon, Georgia, United States

EmVenio Research Center at Prime Healthcare - Riverdale

Riverdale, Georgia, United States

ASHA Clinical Research - Munster, LLC

Hammond, Indiana, United States

Digestive Research Alliance of Michiana

South Bend, Indiana, United States

Iowa Digestive Disease Center

Clive, Iowa, United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Kansas Medical Clinic PA

Topeka, Kansas, United States

Tandem Clinical Research

Marrero, Louisiana, United States

Delta Research Partners, LLC

Monroe, Louisiana, United States

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Mercy Medical Center

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Clinical Research Institute of Michigan, LLC

Clinton Township, Michigan, United States

West Michigan Clinical Research Center

Wyoming, Michigan, United States

MNGI Digestive Health, PA

Minneapolis, Minnesota, United States

Gastrointestinal Associates, PA

Flowood, Mississippi, United States

Clinical Research Professionals

Chesterfield, Missouri, United States

ObjectiveHealth-GI Associates Research

Columbia, Missouri, United States

Kansas City Research Institute

Kansas City, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Jubilee Clinical Research, Inc

Las Vegas, Nevada, United States

Excel Clinical Research

Las Vegas, Nevada, United States

Clinical Research of South Nevada

Las Vegas, Nevada, United States

IMA Clinical Research-Warren-69742

Warren Township, New Jersey, United States

NewYork-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States

Basil Clinical

Laurelton, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Coastal Research Institute, LLC

Fayetteville, North Carolina, United States

Carolina Researche

Greenville, North Carolina, United States

Centricity Research (New Bern)

New Bern, North Carolina, United States

M3 Wake Research, Inc.

Raleigh, North Carolina, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Columbus Clinical Research Inc.

Columbus, Ohio, United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States

ObjectiveHealth-DSI Research - Springboro, LLC

Springboro, Ohio, United States

Northshore Gastroenterology Research

Westlake, Ohio, United States

Options Health Research

Tulsa, Oklahoma, United States

US Digestive Health

Flourtown, Pennsylvania, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

US Digestive Health

Lancaster, Pennsylvania, United States

Geisinger Scenery Park

State College, Pennsylvania, United States

US Digestive Health

Wyomissing, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

ObjectiveHealth-Columbia Digestive Health Research

Columbia, South Carolina, United States

Palmetto Clinical Research

Summerville, South Carolina, United States

ClinSearch, LLC

Chattanooga, Tennessee, United States

Premier Medical Group

Clarksville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Clinical Research Institute, LLC

Arlington, Texas, United States

IMA Clinical Research Austin

Austin, Texas, United States

American Research Corporation - Austin

Austin, Texas, United States

Pinnacle Clinical Research - Austin

Austin, Texas, United States

Velocity Clinical Research, Austin

Austin, Texas, United States

Bellaire Clinical Research, LLC

Bellaire, Texas, United States

South Texas Research Institute - Brownsville

Brownsville, Texas, United States

Epic Medical Research - Carrollton

Carrollton, Texas, United States

Pinnacle Clinical Research - Corpus Christi

Corpus Christi, Texas, United States

North Texas Research Institute - Dallas

Dallas, Texas, United States

Velocity Clinical Research-Dallas-69170

Dallas, Texas, United States

Zenos Clinical Research

Dallas, Texas, United States

GI Alliance Research - Dallas

Dallas, Texas, United States

Soma Clinical Trials

Denison, Texas, United States

Epic Medical Research - DeSoto

DeSoto, Texas, United States

South Texas Research Institute-Edinburg-67012

Edinburg, Texas, United States

Care United Research

Forney, Texas, United States

EmVenio Research Center at Prime Healthcare - Farmers Branch

Garden City, Texas, United States

Epic Medical Research - Garland

Garland, Texas, United States

Pinnacle Clinical Research, LLC

Georgetown, Texas, United States

HRI Medical Center

Houston, Texas, United States

Ben Taub General Hospital

Houston, Texas, United States

Biopharma Informatic, Inc. Research Center

Houston, Texas, United States

Research Physicians Network

Houston, Texas, United States

Epic Clinical Research

Lewisville, Texas, United States

GI Alliance Research - Mansfield

Mansfield, Texas, United States

Biopharma Informatic LLC

McAllen, Texas, United States

Centex Studies, Inc.

McAllen, Texas, United States

Epic Medical Research - Plano

Plano, Texas, United States

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, United States

Brooke Army Medical Center

San Antonio, Texas, United States

Pinnacle Clinical Research - San Antonio

San Antonio, Texas, United States

Clinical Trials of Texas, LLC

San Antonio, Texas, United States

Pinnacle Clinical Research, LLC

San Antonio, Texas, United States

HASresearch

San Antonio, Texas, United States

Velocity Clinical Research, Waco

Waco, Texas, United States

Objective Health-Digestive Research of Central Texas

Waco, Texas, United States

ObjectiveHealth-Digestive Health Research of North Texas

Wichita Falls, Texas, United States

Liver Institute of Virginia-Bremo

Newport News, Virginia, United States

GI Select Health Research LLC

Richmond, Virginia, United States

Medical College of Virginia Hospitals

Richmond, Virginia, United States

Velocity Clinical Research, Seattle

Seattle, Washington, United States

Velocity Clinical Research-Spokane-69716

Spokane, Washington, United States

CIPREC

Buenos Aires, Argentina

IDIM - Instituto de Diagnostico e Investigaciones Metabolicas

Buenos Aires, Argentina

Buenos Aires Macula S.A.

Buenos Aires, Argentina

Mautalen- Salud e Investigacion

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Glenny Corp - Centro Médico Saavedra

Buenos Aires, Argentina

Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553

C.a.b.a, Argentina

Hospital General de Agudos Dr. J. M. Ramos Mejia

Ciudad Autonoma Buenos Aires, Argentina

Hospital Universitario Austral

Pilar, Argentina

DIM Clinica Privada

Ramos Mejía, Argentina

Hospital El Cruce

San Juan Bautista, Argentina

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Nepean Hospital

Kingswood, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Medical University Graz

Graz, Austria

Ordensklinikum Linz GmbH

Linz, Austria

Klinik Landstrasse

Vienna, Austria

AKH - Medical University of Vienna

Vienna, Austria

Hospital Hietzing

Vienna, Austria

Klinikum Wels - Grieskirchen GmbH

Wels, Austria

ULB Hopital Erasme

Brussels, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Edegem - UNIV UZ Antwerpen

Edegem, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Jolimont Hôpital

La Louvière, Belgium

Centre Hospitalier Universitaire de Liège

Liège, Belgium

Roeselare - HOSP AZ Delta

Roeselare, Belgium

Universidade Federal do Rio de Janeiro

Barra, Brazil

Hospital Universitário João de Barros Barreto

Belém, Brazil

Hospital das Clinicas da Universidade Federal de Minas Gerais (HCUFMG)

Belo Horizonte, Brazil

Universidade Estadual Paulista 'Julio De Mesquita Filho'

Botucatu, Brazil

Centro de Pesquisa Clinica do Brasil Ltda

Brasília, Brazil

Hospital das Clinicas da Faculdade de Medicina da USP

Cerqueira César, Brazil

Hospitalar Moinhos de Vento

Porto Alegre, Brazil

Universidade Federal do Rio Grande do Sul

Porto Alegre, Brazil

Hospital de Base - Fac Med de Sao Jose do Rio Preto

São José do Rio Preto, Brazil

Rocco E Nazato Servicos Medicos LTDA

Vila Nova Conceição, Brazil

MHAT Sv. Ivan Rilski EOOD

Gorna Oryahovitsa, Bulgaria

Multi-profile Hospital For Active Treatment-Uni Hospital Ltd.

Panagyurishte, Bulgaria

Acibadem City Clinic Tokuda University Hospital EAD

Sofia, Bulgaria

Diagnostic Consultative Center Alexandrovska

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD

Sofia, Bulgaria

Medical Military Academy MHAT Sofia

Sofia, Bulgaria

Medical Center New Rehabilitation Center EOOD

Stara Zagora, Bulgaria

University of Calgary

Calgary, Alberta, Canada

University of British Columbia

Vancouver, British Columbia, Canada

Pacific Gastroenterology Associates

Vancouver, British Columbia, Canada

Viable Clinical Research

Bridgewater, Nova Scotia, Canada

Toronto Liver Centre

Toronto, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

McGill University Health Centre (MUHC)

Montreal, Quebec, Canada

Centre de Médecine Métabolique de Lanaudière

Terrebonne, Quebec, Canada

Diex Recherche Québec

Québec, Canada

Edificio Fleming

La Serena, Chile

Centro de Investigaciones Médicas UC

Santiago, Chile

Centro de Investigaciones Clinicas Viña del Mar

Viña del Mar, Chile

Beijing Ditan Hospital Capital Medical University

Beijing, China

Beijing Tsinghua Changgung Hospital

Beijing, China

Peking University People's Hospital

Beijing, China

Beijing Friendship Hospital

Beijing, China

Beijing Youan Hospital, Capital Medical University

Beijing, China

The First Hospital of Jilin University

Changchun, China

Hunan Provincial People's Hospital

Changsha, China

Changzhou Third People's Hospital

Changzhou Shi, China

Chongqing Three Gorges Central Hospital

Chongqing, China

The First People's Hospital of Foshan

Foshan, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

Fujian Medical University Union Hospital

Fuzhou, China

Guangzhou Eighth People's Hospital,Guangzhou Medical University

Guangzhou, China

Guangzhou First People's Hospital

Guangzhou, China

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, China

NanFang Hosptial

Guangzhou, China

The third affiliated hospital of Sun Yat-Sen University

Guangzhou, China

Guizhou People's Hospital

Guiyang, China

The First Affiliated Hospital, Zhejiang University

Hangzhou, China

Zhejiang Hospital

Hangzhou, China

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, China

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Hangzhou, China

The First hospital of Jiaxing

Jiaxing, China

Liaocheng People's Hospital

Liaocheng, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

The Second Affiliated Hospital to Nanchang University

Nanchang, China

The Second Hospital of Nanjing

Nanjing, China

Nanjing Drum Tower Hospital

Nanjing, China

Ningbo Second Hospital

Ningbo, China

General Hospital of Ningxia Medical University

Ningxia, China

Pingxiang People's Hospital

Pingxiang, China

Qingdao Municipal Hospital

Qingdao, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Shanghai General Hospital

Shanghai, China

Shanghai East Hospital

Shanghai, China

Renji Hospital Shanghai Jiaotong Univesrity School of Medicine

Shanghai, China

Shanghai Public Health Clinical Center

Shanghai, China

The Sixth People's Hospital of Shenyang

Shenyang, China

The Fifth People's Hospital of Suzhou

Suzhou, China

Tianjin Third Central Hospital

Tianjin, China

Tianjin Second People's Hospital

Tianjin, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Renmin Hospital of Wuhan University

Wuhan, China

Wuxi No. 5 People's Hospital

Wuxi, China

Second Affiliated Hospital of Xi'an JiaoTong University

Xi'an, China

First Affiliated Hospital of Xi'an JiaoTong University

Xi'an, China

Affiliated Hospital, Xuzhou Medical college

Xuzhou, China

Yanbian University Hospital

Yanji, China

Yueyang Central Hospital

Yueyang, China

Yuncheng Center Hopsital - West Compus

Yuncheng, China

Sixth People's Hospital of Zhengzhou

Zhengzhou, China

The Third People's Hospital of Zhenjiang

Zhenjiang, China

Krajska nemocnice Liberec a.s.

Liberec, Czechia

Research Site s.r.o.

Pilsen, Czechia

General Faculty Hospital, Prague

Prague, Czechia

CHU Amiens-Picardie

Amiens, France

Centre Hospitalier Universitaire D'Angers

Angers, France

Hôpital Beaujon

Clichy, France

HOP Dijon-Bourgogne

Côte-d'Or, France

Hôpital Henri Mondor

Créteil, France

Centre Hospitalier De Versailles

Le Chesnay, France

Hôpital Claude Huriez

Lille, France

Hopital De La Croix-Rousse

Lyon, France

Hôpital de l'Archet

Nice, France

Hopitaux Universitaires Pitié-Salpétrière

Paris, France

Hôpital Cochin

Paris, France

Centre Hospitalier Universitaire De Bordeaux

Pessac, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Hôpital Rangueil - CHU de Toulouse

Toulouse, France

Ltd "Health"

Batumi, Georgia

ISR-GEO Med Res Clin Healthycore

Tbilisi, Georgia

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

Bochum, Germany

Universitätsklinikum Köln (AöR)

Cologne, Germany

Technische Universität Dresden

Dresden, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Universität des Saarlandes

Homburg, Germany

Eugastro GmbH

Leipzig, Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, Germany

Otto-von-Guericke-Universität Magdeburg

Magdeburg, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany

Universitätsklinikum Mannheim GmbH

Mannheim, Germany

Universitätsklinikum Münster

Münster, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

St. Josefs-Hospital Wiesbaden

Wiesbaden, Germany

Universitätsklinikum Würzburg AÖR

Würzburg, Germany

Dr. Rethy Pal Hospital

Békéscsaba, Hungary

Obudai Egeszegugyi Centrum Kft.

Budapest, Hungary

Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika

Budapest, Hungary

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

Budapest, Hungary

Aryav Superspeciality Hospital

Ahemdabad, India

Post Graduate Institute of Medical Education and Research

Chandigarh, India

Osmania Medical College & Hospital

Hyderabad, Afzalgunj, India

SR Kalla Memorial Hospital

Jaipur, India

ManglamPlus Medicity Hospital

Jaipur, India

G S V M, Kanpur

Kanpur, India

Atharva Multispecialty Hospital and research Centre

Lucknow, India

Practice Dr Kiranpal Singh

Mohali, India

Midas Multispeciality Hospital Pvt. Ltd.

Nagpur, India

Insitute of Liver and Billiary Sciences

New Delhi, India

All India Institute of Medical Sciences

New Delhi, India

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

Rohtak, India

Yashoda Hospitals - Secunderabad

Secunderabad, India

Surat Institute of Digestive Sciences

Surat, India

BAPS Pramukh Swami Hospital

Surat, India

Gujarat Gastro and Vascular Hospital

Surat, India

Policlinico S. Orsola-Malpighi

Bologna, Italy

Az.Osp. Universitaria "Ospedali Riuniti"

Foggia, Italy

Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico

Milan, Italy

Università degli Studi di Genova

Modena, Italy

Ospedale Maggiore della Carità

Novara, Italy

Policlinico "Paolo Giaccone"

Palermo, Italy

Fondazione Policlinico Universitario Campus Bio-medico

Rome, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Istituto Clinico Humanitas

Rozzano, Italy

IRCCS Ospedale "Casa Sollievo della Sofferenza"

San Giovanni Rotondo, Italy

Universita Degli Studi di Torino

Torino, Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Fujita Health University Hospital

Aichi, Toyoake, Japan

The University of Tokyo Hospital

Bunkyō City, Japan

Chiba University Hospital

Chiba, Japan

Japan Institute for Health Security National Kohnodai Medical Center

Chiba, Ichikawa, Japan

Ehime University Hospital

Ehime, Toon, Japan

Fukuiken Saiseikai Hospital

Fukui, Fukui, Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, Japan

Kurume University Hospital

Fukuoka, Kurume, Japan

Gifu Municipal Hospital

Gifu, Gifu, Japan

Nagano Municipal Hospital

Hanishina-gun, Japan

Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital

Hiroshima, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Sapporo Kosei General Hospital

Hokkaido, Sapporo, Japan

Japan Community Health Care Organization Hokkaido Hospital

Hokkaido, Sapporo, Japan

Hyogo College of Medicine Hospital

Hyogo, Nishinomiya, Japan

Tokyo Medical University Ibaraki Medical Center

Ibaraki, Inashiki-gun, Japan

Tokai University Hospital

Isehara, Japan

Kanazawa University Hospital

Ishikawa, Kanazawa, Japan

Shimane University Hospital

Izumo, Japan

Kagoshima University Hospital

Kagoshima, Kagoshima, Japan

Shin-yurigaoka General Hospital

Kanagawa, Kawasaki, Japan

St. Marianna University Hospital

Kawasaki-shi, Japan

Kagawa University Hospital

Kita-gun, Japan

Kobe University Hospital

Kobe, Japan

Kumamoto University Hospital

Kumamoto, Japan

Kumamoto Shinto General Hospital

Kumamoto, Kumamoto, Japan

National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Kure, Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

University of Miyazaki Hospital

Miyazaki, Miyazaki, Japan

Japanese Red Cross Musashino Hospital

Musashino, Japan

Shinshu University Hospital

Nagano, Matsumoto, Japan

Nagasaki Medical Center

Nagasaki, Omura, Japan

Nara Medical University Hospital

Nara, Kashihara, Japan

International University of Health and Welfare Narita Hospital

Narita, Japan

Niigata University Medical and Dental Hospital

Niigata, Japan

Okayama University Hospital

Okayama, Japan

Osaka City University Hospital

Osaka, Japan

Oita Cardiovascular Hospital

Ōita, Japan

Saga University Hospital

Saga, Japan

Osaka Rosai Hospital

Sakai, Japan

Seichokai Bell Land General Hospital

Sakai, Japan

Sendai Tokushukai Hospital

Sendai, Japan

JCHO Shimonoseki Medical Center

Shimonoseki, Japan

Tokyo Medical University Hospital

Shinjuku-ku, Japan

Iwate Medical University Hospital

Shiwa-gun, Japan

Hamamatsu University Hospital

Shizuoka, Hamamatsu, Japan

Juntendo University Shizuoka Hospital

Shizuoka, Izunokuni, Japan

Suita Hospital

Suita-Shi, Japan

The University of Osaka Hospital

Suita-shi, Japan

National Hospital Organization Takasaki General Medical Center

Takasaki-shi, Japan

Institute of Science Tokyo Hospital

Tokyo, Japan

Nihon University Itabashi Hospital

Tokyo, Japan

Nippon Medical School Hospital

Tokyo, Bunkyo-ku, Japan

Toranomon Hospital

Tokyo, Minato-ku, Japan

Mie University Hospital

Tsu, Japan

Wakayama Medical University Hospital

Wakayama, Japan

Yokohama City University Hospital

Yokohama, Japan

The Speciality Hospital (TSH)

Amman, Jordan

Jordan University Hospital

Jordan, Jordan

Asfendiyarov Kazakh National Medical University

Almaty, Kazakhstan

Institute of Gastroenterology, Hepatology and Metabolism LLP

Almaty, Kazakhstan

Hospital Ampang

Ampang, Malaysia

Hospital Universiti Sains Malaysia

Kota Bharu, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Queen Elizabeth Hospital

Putrajaya, Malaysia

Centro de Investigacion Clinica del Pacifico (CICPA)

Acapulco de Juárez, Mexico

Centro de Investigación y Gastroenterología

Col. Xoco, Mexico

Instituto de Diabetes, Obesidad y Nutrición S.C.

Cuernavaca, Mexico

Clinicos Asociados BOCM SC

Mexico City, Mexico

Centro de Investigación y Gastroenterología

Mexico City, Mexico

Medical Care and Research

Mérida, Mexico

Practice Dr Rosa Isela Luna Ceballos

Veracruz, Mexico

Centro de Alta Especialidad del Estado de Veracruz

Xalapa, Mexico

Amsterdam UMC Locatie VUMC

Amsterdam, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Franciscus Gasthuis

Rotterdam, Netherlands

Tweesteden Ziekenhuis, locatie Tilburg

Tilburg, Netherlands

New Zealand Clinical Research (NZCR)

Grafton, Auckland, New Zealand

Middlemore Hospital

Papatoetoe, Auckland, New Zealand

Christchurch Hospital

Christchurch, Canterbury, New Zealand

Waikato Hospital

Hamilton, Waikato Region, New Zealand

Krakowskie Centrum Medyczne Sp. z o.o.

Krakow, Poland

Santa SP. z o.o

Lodz, Poland

FutureMeds Lodz

Lodz, Poland

Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie

Lublin, Poland

ID Clinic

Mysłowice, Poland

FutureMeds Warszawa Centrum

Warsaw, Poland

Bodyclinic sp. z o.o. sp.k.

Warsaw, Poland

FutureMeds Wroclaw

Wroclaw, Poland

EMC Instytut Medyczny S.A. - Wroclaw

Wroclaw, Poland

Klinical Investigations Group, LLC

San Juan, Puerto Rico

Latin Clinical Trial Center

San Juan, Puerto Rico

FDI Clinical Research

San Juan, Puerto Rico

Arensia Clinics S.R.L.

Bucharest, Romania

Cluj Napoca Clinical County Hospital

Cluj-Napoca, Romania

Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor"

Cluj-Napoca, Romania

Spitalul Clinic Judetean De Urgenta Craiova

Craiova, Romania

Gastromedica Srl

Iași, Romania

Spital Judetean De Urgenta Satu Mare

Satu Mare, Romania

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia

King Abdulaziz Medical City, National Guard Health Affairs

Riyadh, Saudi Arabia

National University Hospital

Singapore, Singapore

Singapore General Hospital

Singapore, Singapore

Changi General Hospital

Singapore, Singapore

Lenasia Clinical Trial Centre

Johannesburg, South Africa

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, South Africa

Inspired GI Care

Plumstead, South Africa

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

Pusan National University Hospital

Busan, South Korea

Yeungnam University Medical Center

Deagu, South Korea

Inha University Hospital

Incheon, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

SMG-SNU Boramae Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Chung-Ang University Hospital

Seoul, South Korea

Yonsei University Wonju Severance Christian Hospital

Wŏnju, South Korea

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario Reina Sofía

Córdoba, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Puerta de Hierro

Majadahonda, Spain

Complexo Hospitalario Universitario de Pontevedra

Pontevedra, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Clínico de Santiago

Santiago de Compostela, Spain

Fondazione Epatocentro Ticino

Arzo, Switzerland

University Hospital Bern

Bern, Switzerland

Hopitaux Universitaires de Geneve (HUG)

Geneva, Switzerland

University Hospital Zurich

Zurich, Switzerland

Chang-Hua Christian Hospital

Changhua, Taiwan

E-Da Hospital

Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsuing City, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Chi Mei Medical Center

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Medical Foundation (CGMF) - Linkou Bran

Taoyuan District, Taiwan

Ankara Üniversitesi Tıp Fakültesi Hastanesi

Ankara, Turkey (Türkiye)

Gazi Universitesi Tip Fakultesi

Ankara, Turkey (Türkiye)

Uludag Universitesi Tip Fakultesi

Bursa, Turkey (Türkiye)

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

Fatih, Turkey (Türkiye)

Koc Universitesi Hastanesi

Istanbul, Turkey (Türkiye)

Memorial Bahçelievler Hospital

Istanbul, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi

Izmir, Turkey (Türkiye)

Recep Tayyip Erdogan Universitesi Egitim ve Arastirma Hastanesi

Rize, Turkey (Türkiye)

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Velocity Clinical Research, Bristol

Bristol, United Kingdom

Frimley Park Hospital

Camberley, United Kingdom

Queen Elizabeth Hospital Birmingham

Edgbaston, Birmingham, United Kingdom

Elpida Clinical Trials - Edgware Community Hospital

Edgware, United Kingdom

Panthera Biopartners - Enfield

Enfield, London, United Kingdom

Royal Devon and Exeter Hospital

Exeter, United Kingdom

Panthera Biopartners - Glasgow

Glasgow, United Kingdom

Hull Royal Infirmary

Hull, United Kingdom

Royal Free Hospital

London, United Kingdom

King's College Hospital

London, United Kingdom

King's College Hospital

London, United Kingdom

Chelsea and Westminster Hospital

London, United Kingdom

St Mary's Hospital

London, United Kingdom

Accellacare North London

Northwood, United Kingdom

Queen's Medical Centre

Nottingham, United Kingdom

Queen's Medical Centre

Nottingham, United Kingdom

Accellacare - South London

Orpington, London, United Kingdom

Panthera Biopartners - Preston

Preston, United Kingdom

Panthera Biopartners - Preston

Preston, United Kingdom

Panthera Biopartners - Rochdale

Rochdale, United Kingdom

Panthera Biopartners - Sheffield

Sheffield, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

St George's Hospital

Tooting, London, United Kingdom

Elpida Clinical Trials - Wigan

Wigan, United Kingdom

Panthera Biopartners - York

York, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06632444