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

August 20, 2026 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1199ABB
      • Buenos Aires, Argentina, 1061
      • Buenos Aires, Argentina, C1056ABJ
        • Recruiting
        • Centro de Investigaciones Metabólicas (CINME)
        • Contact:
      • Buenos Aires, Argentina, C1012AAR
        • Recruiting
        • IDIM - Instituto de Diagnostico e Investigaciones Metabolicas
        • Contact:
      • Buenos Aires, Argentina, C1430CKE
        • Recruiting
        • Glenny Corp - Centro Medico Saavedra
        • Contact:
      • Buenos Aires, Argentina, C1061AAE
      • Buenos Aires, Argentina, C1128AAF
      • Ciudad Autonoma Buenos Aires, Argentina, C1221ADC
        • Recruiting
        • Hospital General de Agudos Dr. J. M. Ramos Mejia
        • Contact:
      • Pilar, Argentina, B1629ODT
      • Ramos Mejía, Argentina, 1704
      • San Juan Bautista, Argentina, B1888
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Recruiting
        • Concord Repatriation General Hospital
        • Contact:
      • Kingswood, New South Wales, Australia, 2747
      • Liverpool, New South Wales, Australia, 2170
      • Westmead, New South Wales, Australia, 2145
    • Queensland
      • Birtinya, Queensland, Australia, 4575
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Heidelberg, Victoria, Australia, 3084
      • Parkville, Victoria, Australia, 3050
    • Western Australia
      • Perth, Western Australia, Australia, 6000
  • Austria
      • Graz, Austria, 8036
      • Linz, Austria, 4010
      • Vienna, Austria, 1090
      • Vienna, Austria, 1130
      • Vienna, Austria, 1030
      • Wels, Austria, 4600
  • Belgium
      • Brussels, Belgium, 1200
        • Not yet recruiting
        • Cliniques Universitaires Saint-Luc
        • Contact:
      • Brussels, Belgium, 1070
      • Edegem, Belgium, 2650
        • Recruiting
        • Universitair Ziekenhuis Antwerpen
        • Contact:
      • Genk, Belgium, 3600
      • Ghent, Belgium, 9000
      • Leuven, Belgium, 3000
        • Suspended
        • UZ Leuven
      • Liège, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Universitaire de Liege
        • Contact:
      • Namur, Belgium, 5004
      • Roeselare, Belgium, 8800
  • Brazil
      • Barra, Brazil, 21941-617
        • Not yet recruiting
        • Universidade Federal do Rio de Janeiro
        • Contact:
      • Belo Horizonte, Brazil, 30130-100
        • Not yet recruiting
        • Hospital das Clinicas da Universidade Federal de Minas Gerais (HC-UFMG)
        • Contact:
      • Belém, Brazil, 66073-005
        • Recruiting
        • Hospital Universitário João de Barros Barreto
        • Contact:
      • Botucatu, Brazil, 18618-970
        • Recruiting
        • Universidade Estadual Paulista 'Julio De Mesquita Filho'
        • Contact:
      • Cerqueira César, Brazil, 05403-000
        • Recruiting
        • Hospital das Clínicas da Faculdade de Medicina da USP
        • Contact:
      • Lago Sul, Brazil, 71625-175
        • Not yet recruiting
        • Centro de Pesquisa Clinica do Brasil
        • Contact:
      • Porto Alegre, Brazil, 90035-903
        • Recruiting
        • Universidade Federal do Rio Grande do Sul
        • Contact:
      • Porto Alegre, Brazil, 90035-001
        • Recruiting
        • Hospitalar Moinhos de Vento
        • Contact:
      • São José do Rio Preto, Brazil, 15090-000
      • São Paulo, Brazil, 04077-020
        • Recruiting
        • Rocco e Nazato Servicos Medicos LTDA
        • Contact:
  • Bulgaria
      • Gorna Oryahovitsa, Bulgaria, 5100
      • Panagyurishte, Bulgaria, 4500
        • Recruiting
        • Multi-profile Hospital For Active Treatment-Uni Hospital Ltd.
        • Contact:
      • Sofia, Bulgaria, 1606
      • Sofia, Bulgaria, 1407
        • Recruiting
        • Acibadem City Clinic Tokuda University Hospital EAD
        • Contact:
      • Sofia, Bulgaria, 1431
        • Recruiting
        • Diagnostic Consultative Center Alexandrovska
        • Contact:
      • Sofia, Bulgaria, 1431
        • Recruiting
        • University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
        • Contact:
      • Stara Zagora, Bulgaria, 6001
        • Recruiting
        • Medical Center New Rehabilitation Center EOOD
        • Contact:
  • Canada
      • Québec, Canada, G1N 4V3
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • University of British Columbia
        • Contact:
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Recruiting
        • Pacific Gastroenterology Associates
        • Contact:
    • Nova Scotia
      • Bridgewater, Nova Scotia, Canada, B4N 3N2
        • Recruiting
        • Viable Clinical Research
        • Contact:
    • Ontario
      • Toronto, Ontario, Canada, M6H 3M1
    • Quebec
      • Montreal, Quebec, Canada, H3H 2R9
        • Not yet recruiting
        • McGill University Health Centre (MUHC)
        • Contact:
      • Montreal, Quebec, Canada, H2X 1R9
        • Not yet recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
        • Contact:
      • Terrebonne, Quebec, Canada, J6X 4P7
        • Recruiting
        • Centre de Medecine Metabolique de Lanaudiere
        • Contact:
  • Chile
      • La Serena, Chile, 1710209
      • Santiago, Chile, 8330024
        • Recruiting
        • Centro de Investigaciones Medicas UC
        • Contact:
      • Viña del Mar, Chile, 2540488
        • Recruiting
        • Centro de Investigaciones Clinicas Vina del Mar
        • Contact:
  • China
      • Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital
        • Contact:
      • Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, China, 102218
        • Recruiting
        • Beijing Tsinghua Changgung Hospital
        • Contact:
      • Beijing, China, 100015
        • Recruiting
        • Beijing Ditan Hospital Capital Medical University
        • Contact:
      • Beijing, China, 100069
        • Recruiting
        • Beijing Youan Hospital, Capital Medical University
        • Contact:
      • Changchun, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Changsha, China, 410008
        • Recruiting
        • Xiangya Hospital, Central South University
        • Contact:
      • Changsha, China, 410005
        • Recruiting
        • Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
        • Contact:
      • Changzhou Shi, China, 214442
        • Recruiting
        • Changzhou Third People's Hospital
        • Contact:
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
      • Chongqing, China, 404000
        • Recruiting
        • Chongqing Three Gorges Central Hospital
        • Contact:
      • Foshan, China, 528000
        • Recruiting
        • The first people's Hospital of Foshan
        • Contact:
      • Fuzhou, China, 350005
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
      • Fuzhou, China, 350025
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Guangzhou, China, 510515
      • Guangzhou, China, 510630
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
      • Guangzhou, China, 510000
        • Recruiting
        • Guangzhou Eighth People's Hospital,Guangzhou Medical University
        • Contact:
      • Guangzhou, China, 510013
        • Recruiting
        • Guangzhou First People's Hospital
        • Contact:
      • Guangzhou, China, 510080
        • Recruiting
        • The First Affiliated Hospital,Sun Yat-sen University
        • Contact:
      • Guiyang, China, 550002
        • Recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
      • Hangzhou, China, 310013
      • Hangzhou, China, 310015
        • Recruiting
        • The Affiliated Hospital of Hangzhou Normal University
        • Contact:
      • Hangzhou, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University
        • Contact:
      • Hangzhou, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
        • Contact:
      • Jiaxing, China, 314001
        • Recruiting
        • The First Hospital of Jiaxing
        • Contact:
      • Liaocheng, China, 252000
        • Recruiting
        • Liaocheng People's Hospital
        • Contact:
      • Luoyang, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science And Technology
        • Contact:
      • Nanchang, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, China, 330006
        • Recruiting
        • The Second Affiliated Hospital to Nanchang University
        • Contact:
      • Nanjing, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Nanjing, China, 210003
        • Recruiting
        • The Second Hospital of Nanjing
        • Contact:
      • Ningbo, China, 315010
        • Recruiting
        • Ningbo Second Hospital
        • Contact:
      • Ningxia, China, 750004
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
      • Pingxiang, China, 337000
        • Recruiting
        • Pingxiang People's Hospital
        • Contact:
      • Qingdao, China, 266001
        • Recruiting
        • Qingdao Municipal Hospital
        • Contact:
      • Shanghai, China, 200120
        • Recruiting
        • Shanghai East Hospital
        • Contact:
      • Shanghai, China, 201508
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:
      • Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital, Fudan University
        • Contact:
      • Shanghai, China, 200080
        • Recruiting
        • Shanghai General Hospital
        • Contact:
      • Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Shanghai, China, 200127
        • Recruiting
        • Renji Hospital Shanghai Jiaotong University school of medicine
        • Contact:
      • Shenyang, China, 110006
        • Recruiting
        • The Sixth People's Hospital of Shenyang
        • Contact:
      • Shenzhen, China, 518112
        • Not yet recruiting
        • The Third People's Hospital of Shenzhen
        • Contact:
      • Suzhou, China, 215007
        • Recruiting
        • The Fifth People's Hospital of Suzhou
        • Contact:
      • Tianjin, China, 300192
        • Recruiting
        • Tianjin Second People's Hospital
        • Contact:
      • Tianjin, China, 300170
        • Recruiting
        • Tianjin Third Central Hospital
        • Contact:
      • Wenzhou, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
      • Wuhan, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Contact:
      • Wuhan, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
      • Wuxi, China, 214005
        • Recruiting
        • Wuxi No. 5 People's Hospital
        • Contact:
      • Xi'an, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, China, 710004
        • Recruiting
        • Second Affiliated Hospital of medical college of Xi'an JiaoTong University
        • Contact:
      • Xuzhou, China, 221002
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical College
        • Contact:
      • Yanji, China, 133000
        • Recruiting
        • Yanbian University Hospital
        • Contact:
      • Yueyang, China, 414000
        • Recruiting
        • Yueyang Central Hospital
        • Contact:
      • Yuncheng, China, 44099
        • Recruiting
        • Yuncheng Center Hopsital - West Compus
        • Contact:
      • Zhengzhou, China, 450005
        • Recruiting
        • Sixth People's Hospital of Zhengzhou
        • Contact:
      • Zhenjiang, China, 212021
        • Recruiting
        • The Third People's Hospital of Zhenjiang
        • Contact:
  • Czechia
      • Liberec, Czechia, 460 01
        • Recruiting
        • Krajska nemocnice Liberec a.s.
        • Contact:
      • Pilsen, Czechia, 301 00
      • Prague, Czechia, 128 08
        • Recruiting
        • General Faculty Hospital, Prague
        • Contact:
  • France
      • Amiens, France, 80054
        • Not yet recruiting
        • CHU Amiens-Picardie
        • Contact:
      • Angers, France, 49100
        • Not yet recruiting
        • Centre Hospitalier Universitaire D'Angers
        • Contact:
      • Clichy, France, 92110
        • Not yet recruiting
        • Hôpital Beaujon
        • Contact:
      • Créteil, France, 94000
        • Not yet recruiting
        • Hôpital Henri Mondor
        • Contact:
      • Côte-d'Or, France, 21000
        • Not yet recruiting
        • HOP Dijon-Bourgogne
        • Contact:
      • Le Chesnay, France, 78150
        • Not yet recruiting
        • Centre Hospitalier de Versailles
        • Contact:
      • Lille, France, 59000
        • Not yet recruiting
        • Hôpital Claude Huriez
        • Contact:
      • Lyon, France, 69004
        • Not yet recruiting
        • Hôpital de la Croix-Rousse
        • Contact:
      • Nice, France, 06200
        • Not yet recruiting
        • Hôpital de l'Archet
        • Contact:
      • Paris, France, 75014
      • Paris, France, 75013
        • Not yet recruiting
        • Hopitaux Universitaires Pitié-Salpétrière
        • Contact:
      • Pessac, France, 33600
        • Not yet recruiting
        • Centre hospitalier universitaire de Bordeaux
        • Contact:
      • Pierre-Bénite, France, 69495
        • Not yet recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
      • Toulouse, France, 31059
        • Not yet recruiting
        • Hôpital Rangueil - CHU de Toulouse
        • Contact:
  • Georgia
      • Batumi, Georgia, 6010
      • Tbilisi, Georgia, 0112
  • Germany
      • Berlin, Germany, 13353
      • Bochum, Germany, 44892
        • Recruiting
        • Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
        • Contact:
      • Cologne, Germany, 50937
      • Dresden, Germany, 01307
      • Erlangen, Germany, 91054
      • Frankfurt, Germany, 69590
      • Heidelberg, Germany, 69120
      • Homburg, Germany, 66421
      • Leipzig, Germany, 04103
      • Lübeck, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
        • Contact:
      • Magdeburg, Germany, 39120
      • Mainz, Germany, 55131
        • Recruiting
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Contact:
      • Mannheim, Germany, 68167
      • Münster, Germany, 49129
      • Tübingen, Germany, 72076
      • Wiesbaden, Germany, 65189
      • Würzburg, Germany, 97080
  • Hungary
      • Budapest, Hungary, 1097
        • Recruiting
        • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
        • Contact:
      • Budapest, Hungary, 1036
      • Budapest, Hungary, 1082
        • Recruiting
        • Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika
        • Contact:
      • Békéscsaba, Hungary, 5600
  • India
      • Ahemdabad, India, 380060
        • Recruiting
        • Aryav Superspeciality Hospital
        • Contact:
      • Chandigarh, India, 14209-1120
        • Recruiting
        • Post Graduate Institute of Medical Education and Research
        • Contact:
      • Hyderabad, Afzalgunj, India, 500012
        • Recruiting
        • Osmania Medical College & Hospital
        • Contact:
      • Jaipur, India, 302001
        • Recruiting
        • SR Kalla Memorial Hospital
        • Contact:
      • Jaipur, India, 302020
        • Recruiting
        • ManglamPlus Medicity Hospital
        • Contact:
      • Lucknow, India, 226003
        • Recruiting
        • Atharva Multispecialty Hospital and research Centre
        • Contact:
      • Mohali, India, 160062
        • Recruiting
        • Fortis Hospital, Mohali
        • Contact:
      • Nagpur, India, 440010
        • Recruiting
        • Midas Multispeciality Hospital Pvt. Ltd.
        • Contact:
      • New Delhi, India, 110029
        • Recruiting
        • All India Institute of Medical Sciences
        • Contact:
      • New Delhi, India, 110 070
        • Recruiting
        • Insitute of Liver and Billiary Sciences
        • Contact:
      • Rohtak, India, 124001
        • Recruiting
        • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
        • Contact:
      • Secunderabad, India, 500003
        • Recruiting
        • Yashoda Hospitals - Secunderabad
        • Contact:
      • Surat, India, 395002
        • Recruiting
        • Surat Institute of Digestive Sciences
        • Contact:
      • Surat, India, 395009
        • Recruiting
        • Gujarat Gastro and Vascular Hospital
        • Contact:
      • Surat, India, 395009
        • Recruiting
        • BAPS Pramukh Swami Hospital
        • Contact:
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Policlinico S. Orsola-Malpighi
        • Contact:
      • Foggia, Italy, 71122
        • Recruiting
        • Az.Osp. Universitaria "Ospedali Riuniti"
        • Contact:
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
        • Contact:
      • Modena, Italy, 41121
        • Recruiting
        • Università di Modena e Reggio Emilia
        • Contact:
      • Novara, Italy, 28100
        • Not yet recruiting
        • Ospedale Maggiore della Carità
        • Contact:
      • Palermo, Italy, 90127
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
        • Contact:
      • Rome, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
      • Rome, Italy, 00128
        • Recruiting
        • Fondazione Policlinico Universitario Campus Bio-Medico
        • Contact:
      • Rozzano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
        • Contact:
      • San Giovanni Rotondo, Italy, 71013
        • Recruiting
        • IRCCS Ospedale "Casa Sollievo della Sofferenza"
        • Contact:
      • Torino, Italy, 10126
        • Recruiting
        • Universita Degli Studi di Torino
        • Contact:
      • Verona, Italy, 37134
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona
        • Contact:
  • Japan
      • Bunkyō City, Japan, 113-8655
        • Recruiting
        • The University of Tokyo Hospital
        • Contact:
      • Chiba, Japan, 260-8677
        • Recruiting
        • Chiba University Hospital
        • Contact:
      • Chiba, Ichikawa, Japan, 272-8516
        • Recruiting
        • Japan Institute for Health Security National Kohnodai Medical Center
        • Contact:
      • Ehime, Toon, Japan, 791-0295
        • Recruiting
        • Ehime University Hospital
        • Contact:
      • Fukui, Japan, 918-8503
        • Recruiting
        • Fukuiken Saiseikai Hospital
        • Contact:
      • Fukuoka, Fukuoka, Japan, 810-8563
        • Recruiting
        • National Hospital Organization Kyushu Medical Center
        • Contact:
      • Fukuoka, Kurume, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital
        • Contact:
      • Gifu, Gifu, Japan, 500-8513
        • Recruiting
        • Gifu Municipal Hospital
        • Contact:
      • Hanishina-gun, Japan, 381-8551
        • Recruiting
        • Nagano Municipal Hospital
        • Contact:
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • Hiroshima University Hospital
        • Contact:
      • Hiroshima, Japan, 730-0052
        • Recruiting
        • Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 062-8618
        • Recruiting
        • Japan Community Health care Organization Hokkaido Hospital
        • Contact:
      • Hyogo, Nishinomiya, Japan, 663-8501
        • Recruiting
        • Hyogo College of Medicine Hospital
        • Contact:
      • Ibaraki, Inashiki-gun, Japan, 300-0395
        • Recruiting
        • Tokyo Medical University Ibaraki Medical Center
        • Contact:
      • Isehara, Japan, 259-1193
        • Recruiting
        • Tokai University Hospital
        • Contact:
      • Ishikawa, Kanazawa, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital
        • Contact:
      • Izumo, Japan, 693-8501
        • Recruiting
        • Shimane University Hospital
        • Contact:
      • Kagoshima, Kagoshima, Japan, 890-8520
        • Recruiting
        • Kagoshima University Hospital
        • Contact:
      • Kanagawa, Kawasaki, Japan, 215-0026
        • Recruiting
        • Shin-yurigaoka General Hospital
        • Contact:
      • Kawasaki-shi, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital
        • Contact:
      • Kita-gun, Japan, 761-0793
        • Recruiting
        • Kagawa University Hospital
        • Contact:
      • Kobe, Japan, 650-0017
        • Recruiting
        • Kobe University Hospital
        • Contact:
      • Kumamoto, Japan, 860-8556
        • Recruiting
        • Kumamoto University Hospital
        • Contact:
      • Kumamoto, Japan, 862-8655
        • Recruiting
        • Kumamoto Shinto General Hospital
        • Contact:
      • Kure, Japan, 737-0023
        • Recruiting
        • National Hospital Organization Kure Medical Center and Chugoku Cancer Center
        • Contact:
      • Kyoto, Japan, 602-8566
        • Recruiting
        • University Hospital Kyoto Prefectural University of Medicine
        • Contact:
      • Miyazaki, Japan, 889-1692
        • Recruiting
        • University of Miyazaki Hospital
        • Contact:
      • Musashino, Japan, 186-8610
        • Recruiting
        • Japanese Red Cross Musashino Hospital
        • Contact:
      • Nagano, Matsumoto, Japan, 390-8621
        • Recruiting
        • Shinshu University Hospital
        • Contact:
      • Nagasaki, Omura, Japan, 856-8562
        • Recruiting
        • Nagasaki Medical Center
        • Contact:
      • Nara, Kashihara, Japan, 634-8522
        • Recruiting
        • Nara Medical University Hospital
        • Contact:
      • Narita, Japan, 286-0105
        • Recruiting
        • International University of Health and Welfare Narita Hospital
        • Contact:
      • Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical and Dental Hospital
        • Contact:
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital
        • Contact:
      • Osaka, Japan, 545-0051
        • Recruiting
        • Osaka City University Hospital
        • Contact:
      • Saga, Japan, 849-8501
        • Recruiting
        • Saga University Hospital
        • Contact:
      • Sakai, Japan, 591-8025
      • Sakai, Japan, 599-8247
        • Recruiting
        • Seichokai Bell Land General Hospital
        • Contact:
      • Sapporo, Japan, 060-0033
        • Recruiting
        • Sapporo Kosei General Hospital
        • Contact:
      • Sendai, Japan, 981-3116
        • Recruiting
        • Sendai Tokushukai Hospital
        • Contact:
      • Shimonoseki, Japan, 750-0061
        • Recruiting
        • JCHO Shimonoseki Medical center
        • Contact:
      • Shiwa-gun, Japan, 028-3695
        • Not yet recruiting
        • Iwate Medical University Hospital
        • Contact:
      • Shizuoka, Hamamatsu, Japan, 431-3192
        • Recruiting
        • Hamamatsu University Hospital
        • Contact:
      • Shizuoka, Izunokuni, Japan, 410-2295
        • Recruiting
        • Juntendo University Shizuoka Hospital
        • Contact:
      • Suita, Japan, 565-0871
        • Recruiting
        • The University of Osaka Hospital
        • Contact:
      • Suita-Shi, Japan, 564-0013
      • Takasaki-shi, Japan, 370-0829
        • Recruiting
        • National Hospital Organization Takasaki General Medical Center
        • Contact:
      • Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital
        • Contact:
      • Tokyo, Japan, 173-8610
        • Not yet recruiting
        • Nihon University Itabashi Hospital
        • Contact:
      • Tokyo, Japan, 113-8519
        • Recruiting
        • Institute of Science Tokyo Hospital
        • Contact:
      • Tokyo, Bunkyo-ku, Japan, 113-8603
        • Recruiting
        • Nippon Medical School Hospital
        • Contact:
      • Tokyo, Minato-ku, Japan, 105-8470
      • Toyoake-shi, Japan, 470-1192
        • Recruiting
        • Fujita Health University Hospital
        • Contact:
      • Tsu, Japan, 514-8507
        • Recruiting
        • Mie University Hospital
        • Contact:
      • Wakayama, Japan, 641-8509
        • Recruiting
        • Wakayama Medical University Hospital
        • Contact:
      • Yokohama, Japan, 236-0004
        • Recruiting
        • Yokohama City University Hospital
        • Contact:
      • Ōita, Japan, 870-0837
        • Recruiting
        • Oita Cardiovascular Hospital
        • Contact:
  • Jordan
      • Amman, Jordan, 11194
        • Recruiting
        • The Speciality Hospital (TSH)
        • Contact:
      • Jordan, Jordan, 13046
        • Recruiting
        • Jordan University Hospital
        • Contact:
  • Kazakhstan
      • Almaty, Kazakhstan, 050000
        • Recruiting
        • Asfendiyarov Kazakh National Medical University
        • Contact:
      • Almaty, Kazakhstan, 050026
        • Recruiting
        • Institute of Gastroenterology, Hepatology and Metabolism LLP
        • Contact:
  • Malaysia
      • Ampang, Malaysia, 68000
      • Kota Bharu, Malaysia, 16150
        • Recruiting
        • Hospital Universiti Sains Malaysia
        • Contact:
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre
        • Contact:
      • Putrajaya, Malaysia, 0000
  • Mexico
      • Acapulco de Juárez, Mexico, 39670
        • Recruiting
        • Centro de Investigacion Clinica del Pacifico (CICPA)
        • Contact:
      • Col. Xoco, Mexico, 03339
        • Recruiting
        • Centro de Investigación y Gastroenterología
        • Contact:
      • Cuernavaca, Mexico, 62250
        • Recruiting
        • Instituto de Diabetes, Obesidad y Nutrición S.C.
        • Contact:
      • Mexico City, Mexico, 03300
        • Recruiting
        • Clinicos Asociados BOCM SC
        • Contact:
      • Mexico City, Mexico, 06700
        • Recruiting
        • Centro de Investigación y Gastroenterología
        • Contact:
      • Mérida, Mexico, 97070
        • Recruiting
        • Medical Care and Research
        • Contact:
      • Veracruz, Mexico, 91910
        • Recruiting
        • Practice Dr Rosa Isela Luna Ceballos
        • Contact:
      • Xalapa, Mexico, 91020
        • Recruiting
        • Centro de Alta Especialidad del Estado de Veracruz
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1081HV
      • Dordrecht, Netherlands, 3318 AT
      • Nijmegen, Netherlands, 6525 GA
        • Recruiting
        • Radboud Universitair Medisch Centrum
        • Contact:
      • Rotterdam, Netherlands, 3015 GD
      • Schiedam, Netherlands, 3118 JH
      • Tilburg, Netherlands, 5042 AD
        • Recruiting
        • Tweesteden Ziekenhuis, locatie Tilburg
        • Contact:
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1010
      • Papatoetoe, Auckland, New Zealand, 2025
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8140
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3240
  • Poland
      • Krakow, Poland, 31-501
        • Recruiting
        • Medical Centre FutureMeds Krakow
        • Contact:
      • Lodz, Poland, 91-363
      • Lodz, Poland, 90-302
      • Lublin, Poland, 20-081
        • Recruiting
        • Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
        • Contact:
      • Mysłowice, Poland, 41-400
      • Warsaw, Poland, 00-215
        • Recruiting
        • FutureMeds Warszawa Centrum
        • Contact:
      • Warsaw, Poland, 03-712
        • Recruiting
        • Bodyclinic Sp. z o.o. sp.k.
        • Contact:
      • Wroclaw, Poland, 53-673
      • Wroclaw, Poland, 54-144
        • Recruiting
        • EMC Instytut Medyczny S.A. - Wroclaw
        • Contact:
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Latin Clinical Trial Center
        • Contact:
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Klinical Investigations Group, LLC
        • Contact:
  • Romania
      • Bucharest, Romania, 011658
        • Not yet recruiting
        • Arensia Clinics S.R.L.
        • Contact:
      • Cluj-Napoca, Romania, 400006
        • Recruiting
        • Cluj Napoca Clinical County Hospital
        • Contact:
      • Cluj-Napoca, Romania, 400162
        • Recruiting
        • Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor"
        • Contact:
      • Craiova, Romania, 200642
        • Recruiting
        • Spitalul Clinic Judetean de Urgenta Craiova
        • Contact:
      • Iași, Romania, 700506
      • Satu Mare, Romania, 440055
        • Recruiting
        • Spital Judetean De Urgenta Satu Mare
        • Contact:
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11564
        • Recruiting
        • King Faisal Specialist Hospital and Research Center
        • Contact:
      • Riyadh, Saudi Arabia, 14611
        • Recruiting
        • King Abdulaziz Medical City, National Guard Health Affairs
        • Contact:
  • Singapore
      • Singapore, Singapore, 169608
      • Singapore, Singapore, 119074
      • Singapore, Singapore, 529889
  • South Africa
      • Johannesburg, South Africa, 2000
        • Not yet recruiting
        • Charlotte Maxeke Johannesburg Academic Hospital
        • Contact:
      • Johannesburg, South Africa, 1827
      • Plumstead, South Africa, 7800
  • South Korea
      • Bucheon-si, South Korea, 14584
        • Recruiting
        • Soon Chun Hyang University Hospital Bucheon
        • Contact:
      • Busan, South Korea, 49241
        • Recruiting
        • Pusan National University Hospital
        • Contact:
      • Deagu, South Korea, 42415
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
      • Incheon, South Korea, 22332
        • Recruiting
        • Inha University Hospital
        • Contact:
      • Seoul, South Korea, 05505
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, South Korea, 07061
        • Recruiting
        • SMG-SNU Boramae Medical Center
        • Contact:
      • Seoul, South Korea, 6351
      • Seoul, South Korea, 08308
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
      • Seoul, South Korea, 6973
        • Recruiting
        • Chung-Ang University Hospital
        • Contact:
      • Wŏnju, South Korea, 26426
        • Recruiting
        • Yonsei University Wonju Severance Christian Hospital
        • Contact:
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario A Coruña
        • Contact:
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Majadahonda, Spain, 28222
        • Recruiting
        • Hospital Puerta de Hierro
        • Contact:
      • Pontevedra, Spain, 36071
        • Recruiting
        • Complexo Hospitalario Universitario de Pontevedra
        • Contact:
      • Santander, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Hospital Clinico de Santiago
        • Contact:
  • Switzerland
      • Arzo, Switzerland, 6900
        • Recruiting
        • Fondazione Epatocentro Ticino
        • Contact:
      • Bern, Switzerland, 3010
        • Recruiting
        • University Hospital Bern
        • Contact:
      • Geneva, Switzerland, 1205
        • Recruiting
        • Hopitaux Universitaires de Geneve (HUG)
        • Contact:
      • Zurich, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich
        • Contact:
  • Taiwan
      • Changhua, Taiwan, 50006
        • Recruiting
        • Changhua Christian Hospital
        • Contact:
      • Kaohsiung City, Taiwan, 824005
      • Kaohsuing City, Taiwan, 80756
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
      • Taichung, Taiwan, 40201
        • Recruiting
        • Chung Shan Medical University Hospital
        • Contact:
      • Tainan, Taiwan, 70403
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
      • Tainan, Taiwan, 71004
      • Taipei, Taiwan, 110301
        • Recruiting
        • Taipei Medical University Hospital
        • Contact:
      • Taipei, Taiwan, 10048
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
      • Taipei, Taiwan, 112201
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
      • Taoyuan, Taiwan, 33305
        • Recruiting
        • Chang Gung Medical Foundation (CGMF) - Linkou Bran
        • Contact:
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Ankara Üniversitesi Tıp Fakültesi Hastanesi
        • Contact:
      • Ankara, Turkey (Türkiye), 06560
        • Recruiting
        • Gazi Universitesi Tip Fakultesi
        • Contact:
      • Bursa, Turkey (Türkiye), 16059
        • Recruiting
        • Uludag Universitesi Tip Fakultesi
        • Contact:
      • Fatih, Turkey (Türkiye), 34093
        • Recruiting
        • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
        • Contact:
      • Istanbul, Turkey (Türkiye), 34180
        • Recruiting
        • Memorial Bahçelievler Hospital
        • Contact:
      • Istanbul, Turkey (Türkiye), 34010
        • Recruiting
        • Koç Üniversitesi Hastanesi
        • Contact:
      • Izmir, Turkey (Türkiye), 35030
        • Recruiting
        • Ege Universitesi Tip Fakultesi
        • Contact:
      • Rize, Turkey (Türkiye), 53020
        • Recruiting
        • Recep Tayyip Erdogan Universitesi Egitim ve Arastirma Hastanesi
        • Contact:
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
      • Ashton in Makerfield, United Kingdom, WN4 8LB
      • Bristol, United Kingdom, BS82RA
      • Camberley, United Kingdom, GU16 7UJ
      • Edgbaston, Birmingham, United Kingdom, B15 2WB
      • Edgware, United Kingdom, HA8 0AD
        • Recruiting
        • Elpida Clinical Trials - Edgware Community Hospital
        • Contact:
      • Enfield, London, United Kingdom, EN3 4GS
      • Exeter, United Kingdom, EX2 5AX
      • Glasgow, United Kingdom, G51 4TY
      • Hull, United Kingdom, HU3 2JZ
      • London, United Kingdom, NW3 2QG
      • London, United Kingdom, SE5 9RS
      • London, United Kingdom, SW10 9NH
      • Newcastle upon Tyne, United Kingdom, NE4 6BE
      • Northwood, United Kingdom, HA6 2RN
      • Nottingham, United Kingdom, NG7 2UH
      • Orpington, London, United Kingdom, BR5 3QG
      • Preston, United Kingdom, PR2 9RB
      • Rochdale, United Kingdom, OL11 4AU
      • Sheffield, United Kingdom, S2 5FX
      • Southampton, United Kingdom, SO16 6YD
      • Tooting, London, United Kingdom, SW17 0QT
      • York, United Kingdom, YO24 4LJ
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Recruiting
        • The Institute for Liver Health II DBA Arizona Clinical Trials
        • Contact:
      • Scottsdale, Arizona, United States, 85258
      • Tucson, Arizona, United States, 85712
      • Tucson, Arizona, United States, 85715
      • Tucson, Arizona, United States, 85712
    • California
      • Canoga Park, California, United States, 91303
      • Chula Vista, California, United States, 91911
      • Coronado, California, United States, 92118
      • Fountain Valley, California, United States, 92708
      • Fresno, California, United States, 93720
      • Gardena, California, United States, 90247
      • Huntington Park, California, United States, 90255
      • Inglewood, California, United States, 90301
      • La Mesa, California, United States, 91942
      • Lancaster, California, United States, 93534
      • Long Beach, California, United States, 90815
      • Los Angeles, California, United States, 90057
      • Montclair, California, United States, 91763
      • Orange, California, United States, 92868
      • Oxnard, California, United States, 93030
      • Pasadena, California, United States, 91105
      • Poway, California, United States, 92064
      • Poway, California, United States, 92064
      • Rialto, California, United States, 92377
      • San Bernardino, California, United States, 92404
      • San Diego, California, United States, 92123
        • Not yet recruiting
        • Medical Associates Research Group, Inc.
        • Contact:
      • San Diego, California, United States, 92120
      • Santa Ana, California, United States, 92704
        • Terminated
        • Velocity Clinical Research, Santa Ana
      • Van Nuys, California, United States, 91405
      • Victorville, California, United States, 92395
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
      • Englewood, Colorado, United States, 80113
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Recruiting
        • Connecticut Gastroenterology Clinical Research Foundation
        • Contact:
      • New Haven, Connecticut, United States, 06520
    • Florida
      • Altamonte Springs, Florida, United States, 32714
      • Bradenton, Florida, United States, 34209
      • Brandon, Florida, United States, 33511
      • Brooksville, Florida, United States, 34613
      • Clearwater, Florida, United States, 33761
      • Clermont, Florida, United States, 34711
      • Coral Gables, Florida, United States, 33134
      • Cutler Bay, Florida, United States, 33189
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • Covenant Metabolic Specialists, LLC - Fort Myers
        • Contact:
      • Gainesville, Florida, United States, 32610
      • Hialeah, Florida, United States, 33016
      • Hialeah Gardens, Florida, United States, 33016
      • Homestead, Florida, United States, 33030
      • Lady Lake, Florida, United States, 32159
      • Lakewood Rch, Florida, United States, 34211
      • Maitland, Florida, United States, 32751
      • Miami, Florida, United States, 33176
      • Miami, Florida, United States, 33134
      • Miami, Florida, United States, 33135
      • Miami, Florida, United States, 33176
      • Miami, Florida, United States, 33156
      • Miami, Florida, United States, 33136
      • Miami Lakes, Florida, United States, 33016
      • Naples, Florida, United States, 34102
      • Orlando, Florida, United States, 32803
      • Orlando, Florida, United States, 32828
      • Orlando, Florida, United States, 32806
        • Terminated
        • K2 Medical Research
      • Palmetto Bay, Florida, United States, 33157
      • Pembroke Pines, Florida, United States, 33024
        • Recruiting
        • MplusM - Best Choice Medical and Research Service
        • Contact:
      • Port Orange, Florida, United States, 32127
      • Riverview, Florida, United States, 33578
        • Recruiting
        • Covenant Metabolic Specialist, LLC - Riverview
        • Contact:
      • St. Petersburg, Florida, United States, 33714
      • Tampa, Florida, United States, 33618
      • The Villages, Florida, United States, 32162
      • University Park, Florida, United States, 34201
        • Recruiting
        • Covenant Metabolic Specialists, LLC - University Park
        • Contact:
      • Winter Park, Florida, United States, 32789
      • Zephyrhills, Florida, United States, 33542
    • Georgia
      • Macon, Georgia, United States, 31201
        • Recruiting
        • Gastroenterology Associates of Central Georgia
        • Contact:
      • Riverdale, Georgia, United States, 30274
        • Recruiting
        • EmVenio Research Center at Prime Healthcare - Riverdale
        • Contact:
    • Indiana
      • Hammond, Indiana, United States, 46324
      • South Bend, Indiana, United States, 46635
    • Iowa
      • Clive, Iowa, United States, 50325
      • West Des Moines, Iowa, United States, 50265
        • Recruiting
        • Iowa Diabetes and Endocrinology Research Center
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
      • Topeka, Kansas, United States, 66606-1707
    • Louisiana
      • Bastrop, Louisiana, United States, 71220
      • Marrero, Louisiana, United States, 70072
      • Shreveport, Louisiana, United States, 71105
    • Maryland
      • Baltimore, Maryland, United States, 21202
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
    • Michigan
      • Clinton Township, Michigan, United States, 48038
      • Wyoming, Michigan, United States, 49519
    • Minnesota
      • Minneapolis, Minnesota, United States, 55413
    • Mississippi
      • Flowood, Mississippi, United States, 39232
    • Missouri
      • Chesterfield, Missouri, United States, 63005
      • Columbia, Missouri, United States, 65201
      • Kansas City, Missouri, United States, 64131
    • Nebraska
      • Omaha, Nebraska, United States, 68198
    • Nevada
      • Las Vegas, Nevada, United States, 89106
      • Las Vegas, Nevada, United States, 89121
      • Las Vegas, Nevada, United States, 89109
    • New Jersey
      • Warren Township, New Jersey, United States, 07059
    • New York
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • NewYork-Presbyterian Brooklyn Methodist Hospital
        • Contact:
      • Laurelton, New York, United States, 11413
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
      • Rochester, New York, United States, 14642
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • Fayetteville, North Carolina, United States, 28304
      • Greenville, North Carolina, United States, 27834
      • New Bern, North Carolina, United States, 28562
      • Raleigh, North Carolina, United States, 27612
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:
      • Mentor, Ohio, United States, 44060
      • Springboro, Ohio, United States, 45066
        • Recruiting
        • ObjectiveHealth-DSI Research - Springboro, LLC
        • Contact:
      • Westlake, Ohio, United States, 44145
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
    • Pennsylvania
      • Flourtown, Pennsylvania, United States, 19031
      • Hershey, Pennsylvania, United States, 17033
      • Lancaster, Pennsylvania, United States, 17601
      • State College, Pennsylvania, United States, 16801
      • Wyomissing, Pennsylvania, United States, 19610
    • South Carolina
      • Charleston, South Carolina, United States, 29425
      • Columbia, South Carolina, United States, 29204
        • Recruiting
        • ObjectiveHealth-Columbia Digestive Health Research
        • Contact:
      • Summerville, South Carolina, United States, 29485
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
      • Clarksville, Tennessee, United States, 37040
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Arlington, Texas, United States, 76012
      • Austin, Texas, United States, 78757
      • Austin, Texas, United States, 78759
      • Austin, Texas, United States, 78745
      • Austin, Texas, United States, 78757
      • Bellaire, Texas, United States, 77401
      • Brownsville, Texas, United States, 78520
      • Carrollton, Texas, United States, 75006
      • Corpus Christi, Texas, United States, 78404
      • Dallas, Texas, United States, 75230
      • Dallas, Texas, United States, 75246
      • Dallas, Texas, United States, 75230
      • Dallas, Texas, United States, 75150
      • DeSoto, Texas, United States, 75115
      • Denison, Texas, United States, 75020
      • Edinburg, Texas, United States, 78539
      • Forney, Texas, United States, 75126
      • Garden City, Texas, United States, 48135
        • Recruiting
        • EmVenio Research Center at Prime Healthcare - Farmers Branch
        • Contact:
      • Garland, Texas, United States, 75043
      • Georgetown, Texas, United States, 78626
      • Houston, Texas, United States, 77084
      • Houston, Texas, United States, 77089
      • Houston, Texas, United States, 77030-1608
      • Houston, Texas, United States, 77004
      • Lewisville, Texas, United States, 75057
      • Mansfield, Texas, United States, 76063
      • McAllen, Texas, United States, 78503
      • McAllen, Texas, United States, 78504
      • Plano, Texas, United States, 75093
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • American Research Corporation at the Texas Liver Institute
        • Contact:
      • San Antonio, Texas, United States, 78219
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78240
      • San Antonio, Texas, United States, 78222
      • Waco, Texas, United States, 76710
      • Waco, Texas, United States, 76712
        • Recruiting
        • Objective Health-Digestive Research of Central Texas
        • Contact:
      • Wichita Falls, Texas, United States, 76301
        • Recruiting
        • ObjectiveHealth-Digestive Health Research of North Texas
        • Contact:
    • Virginia
      • Newport News, Virginia, United States, 23601
      • Richmond, Virginia, United States, 23236
      • Richmond, Virginia, United States, 23298
    • Washington
      • Seattle, Washington, United States, 98105
      • Spokane, Washington, United States, 99218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. 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
  2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score [NAS] ≥4
  3. 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
  4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply

Exclusion criteria:

  1. 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
  2. Any history or evidence of acute or chronic liver disease other than MASH
  3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy
  4. History of or current diagnosis of hepatocellular carcinoma
  5. History of or planned liver transplant
  6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.
  7. History of portal hypertension or presence of decompensated liver disease
  8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Combination product: Placebo
Subcutaneous injection, prefilled syringe
Experimental: Survodutide
Combination product: Survodutide
Subcutaneous injection, prefilled syringe
Other Names:
  • BI 456906

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score
Time Frame: Baseline and at Week 52.
Baseline and at Week 52.
Part 1: At least a 1-point improvement in fibrosis stage with no worsening of MASH
Time Frame: Baseline and at Week 52.
Baseline and at Week 52.
Part 2: Time to first occurrence of any of components of the composite endpoint consisting of progression to cirrhosis, all-cause mortality, liver transplant, hepatic decompensation event(s), worsening of MELD score to ≥15, progression to CSPH
Time Frame: Up to 7 years.
Progression to cirrhosis is defined as histological fibrosis score CRN F4. MELD = Model for End-stage Liver Disease CSPH =clinically significant portal hypertension
Up to 7 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Key secondary endpoint part 1: Absolute change from baseline in enhanced liver fibrosis (ELF) score
Time Frame: Baseline and at Week 52.
Baseline and at Week 52.
Key secondary endpoint part 1: Achievement of no progression of fibrosis assessed by central pathology (yes/no)
Time Frame: Baseline and at Week 52.
Baseline and at Week 52.
Key secondary endpoint part 2: Absolute change from baseline in ELF score
Time Frame: At baseline and at Week 114.
At baseline and at Week 114.
Key secondary endpoint part 2: Achievement of no progression of fibrosis assessed by central pathology (yes/no)
Time Frame: At baseline and at 7 years.
At baseline and at 7 years.
Key secondary endpoint part 2: Occurrence of all-cause hospitalisation (first and recurrent)
Time Frame: Up to 7 years.
Up to 7 years.
Key secondary endpoint part 2: Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE)5-point major adverse cardiac event (5P-MACE)
Time Frame: Up to 7 years.
Up to 7 years.
Part 1: Absolute change from baseline in alanine aminotransferase (ALT) [U/L]
Time Frame: At baseline and at Week 52.
At baseline and at Week 52.
Part 2: Absolute change from baseline in alanine aminotransferase (ALT) [U/L]
Time Frame: At baseline and at Week 114.
At baseline and at Week 114.
Part 1: Absolute change from baseline in aspartate aminotransferase (AST) [U/L]
Time Frame: At baseline and at Week 52.
At baseline and at Week 52.
Part 2: Absolute change from baseline in aspartate aminotransferase (AST) [U/L]
Time Frame: At baseline and at Week 114.
At baseline and at Week 114.
Part 1: Absolute change from baseline in systolic blood pressure (SBP) [mmHg]
Time Frame: At baseline and at Week 52.
At baseline and at Week 52.
Part 2: Absolute change from baseline in systolic blood pressure (SBP) [mmHg]
Time Frame: At baseline and at Week 114.
At baseline and at Week 114.
Part 1: Absolute change from baseline in diastolic blood pressure (DBP) [mmHg]
Time Frame: At baseline and at Week 52.
At baseline and at Week 52.
Part 2: Absolute change from baseline in diastolic blood pressure (DBP) [mmHg]
Time Frame: At baseline and at Week 114.
At baseline and at Week 114.
Part 1: Absolute change from baseline in free fatty acids [mg/dL]
Time Frame: At baseline and at Week 52.
At baseline and at Week 52.
Part 2: Absolute change from baseline in free fatty acids [mg/dL]
Time Frame: At baseline and at Week 114.
At baseline and at Week 114.
Part 1: Progression to cirrhosis (defined as histological fibrosis score CRN F4) (yes/no)
Time Frame: At baseline and at Week 52.
At baseline and at Week 52.
Key secondary endpoint part 1: Percentage change from baseline in body weight [kg]
Time Frame: Baseline and at Week 52.
Baseline and at Week 52.
Key secondary endpoint part 1: Absolute change from baseline in glycosylated haemoglobin (HbA1c) [%]
Time Frame: Baseline and at Week 52.
This endpoint is specified only for the participants with type 2 diabetes mellitus.
Baseline and at Week 52.
Key secondary endpoint part 1: Absolute change from baseline in liver stiffness [kPa] assessed by vibration-controlled transient elastography (VCTE)
Time Frame: Baseline and at Week 52.
Baseline and at Week 52.
Key secondary endpoint part 2: Percentage change from baseline in body weight [kg]
Time Frame: At baseline and at Week 114
At baseline and at Week 114
Key secondary endpoint part 2: Absolute change from baseline in HbA1c [%]
Time Frame: At baseline and at Week 114
This endpoint is specified only for the participants with type 2 diabetes mellitus.
At baseline and at Week 114
Key secondary endpoint part 2: Absolute change from baseline in liver stiffness [kPa] assessed by VCTE
Time Frame: At baseline and at Week 114.
At baseline and at Week 114.
Part 1: Improvement of liver fat content (LFC)
Time Frame: At baseline and at Week 52.

Defined as at least 30% relative reduction in LFC compared with baseline assessed by Magnetic resonance imaging proton density fat fraction (MRI-PDFF).

This endpoint will be reported only for a subset of participants in the MRI sub-study.
At baseline and at Week 52.
Part 2: Improvement of LFC
Time Frame: At baseline and at Week 114.

Defined as at least 30% relative reduction in LFC compared with baseline assessed by MRI-PDFF.

This endpoint will be reported only for a subset of participants in the MRI sub-study.
At baseline and at Week 114.
Part 1: Absolute change from baseline in LFC [%] in MRI-PDFF
Time Frame: At baseline and at Week 52.
This endpoint will be reported only for a subset of participants in the MRI sub-study.
At baseline and at Week 52.
Part 2: Absolute change from baseline in LFC [%] in MRI-PDFF
Time Frame: At baseline and at Week 114.
This endpoint will be reported only for a subset of participants in the MRI sub-study.
At baseline and at Week 114.
Part 1: Absolute changes from baseline in lipids [mg/dL] (including but not limited to: total cholesterol, LDL cholesterol, very low-density lipoprotein [VLDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides)
Time Frame: At baseline and at Week 52.
LDL=low-density lipoprotein
At baseline and at Week 52.
Part 2: Absolute changes from baseline in lipids [mg/dL] (including but not limited to: total cholesterol, LDL cholesterol, very low-density lipoprotein [VLDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides)
Time Frame: At baseline and at Week 114.
At baseline and at Week 114.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Estimated)

December 27, 2031

Study Completion (Estimated)

December 27, 2031

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1404-0044
  • 2024-513739-25-00 (Registry Identifier: CTIS)
  • U1111-1306-9071 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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