LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

May 27, 2026 updated by: Boehringer Ingelheim

A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis

This study is open to adults who are at least 18 years old and have:

  • A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or
  • A confirmed liver disease called metabolic-associated steatohepatitis (MASH)
  • BMI of 27 kg/m2 or more or
  • 25 kg/m2 or more if the participant is Asian.

People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.

Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.

Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.

The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1590

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
        • Not yet recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
      • Buenos Aires, Argentina, C1061AAE
      • Buenos Aires, Argentina, 1061
      • Buenos Aires, Argentina, C1430CKE
        • Not yet recruiting
        • Glenny Corp - Centro Médico Saavedra
        • Contact:
      • Buenos Aires, Argentina, C1012AAR
        • Recruiting
        • IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas
        • Contact:
      • C.a.b.a, Argentina, C1056ABJ
        • Recruiting
        • Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
        • Contact:
      • Ciudad Autonoma Buenos Aires, Argentina, C1221ADC
        • Not yet recruiting
        • Hospital General de Agudos Dr. J. M. Ramos Mejia
        • Contact:
      • Pilar, Argentina, B1629ODT
        • Not yet recruiting
        • Hospital Universitario Austral
        • Contact:
      • Ramos Mejía, Argentina, 1704
      • San Juan Bautista, Argentina, B1888
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Completed
        • Concord Repatriation General Hospital
      • Kingswood, New South Wales, Australia, 2747
      • Liverpool, New South Wales, Australia, 2170
      • Westmead, New South Wales, Australia, 2145
    • 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
      • Wels, Austria, 4600
  • Belgium
      • Brussels, Belgium, 1070
      • Edegem, Belgium, 2650
      • Genk, Belgium, 3600
      • Liège, Belgium, 4000
        • Recruiting
        • Centre hospitalier universitaire de Liege
        • Contact:
  • 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 (HCUFMG)
        • Contact:
      • Belém, Brazil, 66073-005
        • Not yet 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 Clinicas Da Faculdade De Medicina Da USP
        • Contact:
      • Porto Alegre, Brazil, 90035-903
        • Recruiting
        • Universidade Federal do Rio Grande do Sul
        • Contact:
      • Porto Alegre, Brazil, 90035-001
        • Not yet recruiting
        • Hospitalar Moinhos de Vento
        • Contact:
      • São José do Rio Preto, Brazil, 15090-000
        • Recruiting
        • Hospital de Base - Fac Med de Sao Jose do Rio Preto
        • Contact:
      • Vila Nova Conceição, Brazil, 04543-011
        • Recruiting
        • Rocco E Nazato Servicos Medicos LTDA
        • Contact:
  • Bulgaria
      • Gorna Oryahovitsa, Bulgaria, 5100
      • Panagyurishte, Bulgaria, 4500
        • Not yet recruiting
        • Multi-profile Hospital For Active Treatment-Uni Hospital Ltd.
        • Contact:
      • Sofia, Bulgaria, 1407
        • Recruiting
        • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
        • Contact:
      • Sofia, Bulgaria, 1606
      • 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, 6003
        • 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
        • Not yet recruiting
        • University of British Columbia
        • 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
        • Recruiting
        • McGill University Health Centre (MUHC)
        • Contact:
  • Chile
      • La Serena, Chile, 1710209
      • Santiago, Chile, 8330024
        • Recruiting
        • Centro de Investigaciones Médicas UC
        • Contact:
      • Viña del Mar, Chile, 2520997
        • Recruiting
        • Centro de Investigaciones Clinicas Viña del Mar
        • Contact:
  • China
      • Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital
        • Contact:
      • Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, China, 100044
        • 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
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Changsha, China, 410005
        • Recruiting
        • Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
        • Contact:
      • Changzhou Shi, China, 214442
        • Not yet recruiting
        • Changzhou Third People's Hospital
        • Contact:
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
      • Chongqing, China, 404000
        • Not yet recruiting
        • Chongqing Three Gorges Central Hospital
        • Contact:
      • Foshan, China, 528000
        • Not yet recruiting
        • The First People's Hospital of Foshan
        • Contact:
      • Fuzhou, China, 350005
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
      • Guangzhou, China, 510515
      • Guangzhou, China, 510013
        • Not yet recruiting
        • Guangzhou First People's Hospital
        • Contact:
      • Guangzhou, China, 510000
        • Recruiting
        • Guangzhou Eighth People's Hospital,Guangzhou Medical University
        • Contact:
      • Hangzhou, China, 310013
      • Hangzhou, China, 310015
        • Recruiting
        • The Affiliated Hospital of Hangzhou Normal University
        • Contact:
      • Hangzhou, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
        • Contact:
      • Hangzhou, China, 310003
        • Not yet recruiting
        • The First Affiliated Hospital, Zhejiang University
        • Contact:
      • Jiaxing, China, 314001
        • Not yet recruiting
        • The First Hospital of Jiaxing
        • Contact:
      • Kunming, China, 650032
        • Not yet recruiting
        • First People's hospital of Yunann Province
        • 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
        • Not yet 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, 211100
        • Recruiting
        • Nanjing Jiangning Hospital
        • Contact:
      • Nanjing, China, 210003
        • Recruiting
        • The Second Hospital of Nanjing
        • Contact:
      • Ningbo, China, 315010
        • Recruiting
        • Ningbo Second Hospital
        • Contact:
      • Ningxia, China, 750004
        • Not yet 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, 200080
        • Recruiting
        • Shanghai General Hospital
        • Contact:
      • Shanghai, China, 200025
        • Not yet recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Shanghai, China, 200127
        • Not yet recruiting
        • Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
        • Contact:
      • Shanghai, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
      • Shenyang, China, 110006
        • Not yet 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:
      • Xi'an, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
      • Xi'an, China, 710004
        • Recruiting
        • Second Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
      • Zhengzhou, China, 450005
        • Not yet recruiting
        • Sixth People's Hospital of Zhengzhou
        • Contact:
      • Zhenjiang, China, 212021
        • Not yet recruiting
        • The Third People's Hospital of Zhenjiang
        • Contact:
  • Czechia
      • Liberec, Czechia, 460 01
        • Recruiting
        • Krajská 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
      • Créteil, France, 94000
        • Not yet recruiting
        • Hopital 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
        • Hopital 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
      • Frankfurt, Germany, 69590
      • Heidelberg, Germany, 69120
      • Homburg, Germany, 66421
      • Lübeck, Germany, 23538
        • Not yet recruiting
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
        • Contact:
      • Magdeburg, Germany, 39120
        • Not yet recruiting
        • Otto-von-Guericke-Universität Magdeburg
        • Contact:
      • Mainz, Germany, 55131
        • Recruiting
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Contact:
      • Mannheim, Germany, 68167
        • Not yet recruiting
        • Universitätsklinikum Mannheim GmbH
        • Contact:
      • Münster, Germany, 49129
      • Wiesbaden, Germany, 65189
      • Würzburg, Germany, 97080
  • Hungary
      • Budapest, Hungary, 1097
        • Recruiting
        • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
        • 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
        • Not yet recruiting
        • Post Graduate Institute of Medical education and Research
        • Contact:
      • Hyderabad, Afzalgunj, India, 500012
        • Recruiting
        • Osmania Medical College & Hospital
        • Contact:
      • Jaipur, India, 302020
        • Not yet recruiting
        • ManglamPlus Medicity Hospital
        • Contact:
      • Jaipur, India, 302001
        • Recruiting
        • SR Kalla Memorial Hospital
        • Contact:
      • Lucknow, India, 226003
        • Recruiting
        • Atharva Multispecialty Hospital and research Centre
        • Contact:
      • Nagpur, India, 440010
        • Recruiting
        • Midas Multispeciality Hospital Pvt. Ltd.
        • 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
      • Abbiategrasso, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
        • Contact:
      • Bologna, Italy, 40138
        • Recruiting
        • Policlinico S. Orsola-Malpighi
        • Contact:
      • Foggia, Italy, 71122
        • Not yet recruiting
        • Az.Osp. Universitaria "Ospedali Riuniti"
        • Contact:
      • Modena, Italy, 41121
        • Not yet recruiting
        • Università degli Studi di Genova
        • 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:
      • Torino, Italy, 10126
        • Recruiting
        • Universita Degli Studi di Torino
        • Contact:
  • Japan
      • Bunkyō City, Japan, 113-8655
        • Not yet recruiting
        • The University of Tokyo Hospital
        • Contact:
      • Chiba, Japan, 260-8677
        • Recruiting
        • Chiba University Hospital
        • Contact:
      • Ehime, Toon, Japan, 791-0295
        • Recruiting
        • Ehime University Hospital
        • Contact:
      • Fukui, Fukui, Japan, 918-8503
        • Recruiting
        • Fukuiken Saiseikai Hospital
        • Contact:
      • Fukuoka, Fukuoka, Japan, 810-8563
        • Not yet 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:
      • Gifu, Ogaki, Japan, 503-8502
        • Recruiting
        • Ogaki Municipal Hospital
        • Contact:
      • Hanishina-gun, Japan, 381-8551
        • Not yet recruiting
        • Nagano Municipal Hospital
        • Contact:
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • Hiroshima University Hospital
        • Contact:
      • Hiroshima, Japan, 730-0052
        • Not yet 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:
      • 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:
      • 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
        • Not yet 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
        • Not yet recruiting
        • International University of Health and Welfare Narita Hospital
        • Contact:
      • Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical And Dental Hospital
        • Contact:
      • Nishinomiya, Japan, 663-8501
        • Recruiting
        • Hyogo College of Medicine Hospital
        • Contact:
      • Okayama, Japan, 700-8558
        • Not yet 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:
      • Shiwa-gun, Japan, 028-3695
        • Not yet recruiting
        • Iwate Medical University Hospital
        • Contact:
      • Shizuoka, Hamamatsu, Japan, 431-3192
        • Not yet 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, 113-8431
        • Not yet recruiting
        • Juntendo University 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
        • Not yet recruiting
        • Toranomon 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
        • Not yet recruiting
        • Asfendiyarov Kazakh National Medical University
        • Contact:
      • Almaty, Kazakhstan, 050026
        • Not yet 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
        • Not yet recruiting
        • Centro de Investigacion Clinica del Pacifico (CICPA)
        • Contact:
      • Col. Xoco, Mexico, 03339
        • Not yet recruiting
        • Centro de Investigación y Gastroenterología
        • Contact:
      • Cuernavaca, Mexico, 62250
        • Not yet recruiting
        • Instituto de Diabetes, Obesidad y Nutrición S.C.
        • Contact:
      • Mexico City, Mexico, 06700
        • Not yet recruiting
        • Centro de Investigación y Gastroenterología
        • Contact:
      • Mexico City, Mexico, 03300
        • Not yet recruiting
        • Clinicos Asociados BOCM SC
        • Contact:
      • Mérida, Mexico, 97070
        • Not yet recruiting
        • Medical Care and Research
        • Contact:
      • Veracruz, Mexico, 91910
        • Not yet recruiting
        • Practice Dr Rosa Isela Luna Ceballos
        • Contact:
      • Xalapa, Mexico, 91020
        • Not yet recruiting
        • Centro de Alta Especialidad del Estado de Veracruz
        • Contact:
  • Netherlands
      • Dordrecht, Netherlands, 3318 AT
      • Rotterdam, Netherlands, 3015 GD
      • Schiedam, Netherlands, 3118 JH
  • 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
      • Cluj-Napoca, Romania, 400162
        • Recruiting
        • Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor"
        • Contact:
      • Satu Mare, Romania, 440055
        • Not yet recruiting
        • Spital Judetean de Urgenta Satu Mare
        • Contact:
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 14611
        • Not yet recruiting
        • King Abdulaziz Medical City, National Guard Health Affairs
        • Contact:
      • Riyadh, Saudi Arabia, 11564
        • Not yet recruiting
        • King Faisal Specialist Hospital and Research Center
        • Contact:
  • Singapore
      • Singapore, Singapore, 169608
      • Singapore, Singapore, 119074
      • Singapore, Singapore, 529889
  • South Africa
      • 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:
      • 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:
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
      • Majadahonda, Spain, 28222
        • Recruiting
        • Hospital Puerta de Hierro
        • Contact:
      • Pontevedra, Spain, 36071
        • Recruiting
        • Complexo Hospitalario Universitario de Pontevedra
        • Contact:
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Hospital Clínico de Santiago
        • Contact:
  • Switzerland
      • Arzo, Switzerland, 6900
        • Recruiting
        • Fondazione Epatocentro Ticino
        • Contact:
      • Geneva, Switzerland, 1205
        • Not yet recruiting
        • Hopitaux Universitaires de Geneve (HUG)
        • Contact:
      • Zurich, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich
        • Contact:
  • Taiwan
      • Changhua, Taiwan, 50006
        • Recruiting
        • Changhua Christian Hospital
        • Contact:
      • 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, 10048
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
      • Taipei, Taiwan, 112201
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
      • Taipei, Taiwan, 110301
        • Not yet recruiting
        • Taipei Medical University Hospital
        • Contact:
      • Taoyuan, Taiwan, 33305
        • Recruiting
        • Chang Gung Medical Foundation (CGMF) - Linkou Bran
        • Contact:
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universitesi Tip Fakultesi
        • 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), 34010
        • Recruiting
        • Koç Üniversitesi Hastanesi
        • Contact:
      • Istanbul, Turkey (Türkiye), 34180
        • Not yet recruiting
        • Memorial Bahçelievler Hospital
        • 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
      • Bristol, United Kingdom, BS82RA
      • Camberley, United Kingdom, GU16 7UJ
      • Derby, United Kingdom, DE22 3NE
      • Edgbaston, Birmingham, United Kingdom, B15 2WB
      • Exeter, United Kingdom, EX2 5AX
      • Glasgow, United Kingdom, G51 4TY
      • Guildford, United Kingdom, GU2 7XX
      • Hull, United Kingdom, HU3 2JZ
      • Liverpool, United Kingdom, L9 7AL
      • London, United Kingdom, SE5 9RS
      • London, United Kingdom, SW10 9NH
      • London, United Kingdom, NW32PF
      • Newcastle upon Tyne, United Kingdom, NE4 6BE
      • Northwood, United Kingdom, HA6 2RN
      • 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
    • 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, 85715
      • Tucson, Arizona, United States, 85712
      • 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
      • Huntington Park, California, United States, 90255
        • Not yet recruiting
        • Velocity Clinical Research-Huntington Park
        • Contact:
      • Inglewood, California, United States, 90301
      • La Mesa, California, United States, 91942
      • Lancaster, California, United States, 93534
      • Montclair, California, United States, 91763
      • Orange, California, United States, 92868
      • Oxnard, California, United States, 93030
      • 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, 92120
    • 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:
    • Florida
      • Brandon, Florida, United States, 33511
      • Brooksville, Florida, United States, 34613
      • 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:
      • Hialeah, Florida, United States, 33016
      • Hialeah Gardens, Florida, United States, 33016
      • Homestead, Florida, United States, 33030
      • Lady Lake, Florida, United States, 32159
      • 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, 33173
      • Miami, Florida, United States, 33136
      • Miami Lakes, Florida, United States, 33016
      • New Port Richey, Florida, United States, 34653
      • Orlando, Florida, United States, 32808
      • Orlando, Florida, United States, 32803
      • Orlando, Florida, United States, 32828
      • Palmetto Bay, Florida, United States, 33157
      • Pembroke Pines, Florida, United States, 33024
        • Recruiting
        • MplusM - Best Choice Medical and Research Service
        • Contact:
      • Riverview, Florida, United States, 33578
        • Not yet recruiting
        • Covenant Metabolic Specialist, LLC - Riverview
        • Contact:
      • St. Petersburg, Florida, United States, 33705
      • St. Petersburg, Florida, United States, 33714
      • Tampa, Florida, United States, 33614
      • 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
      • Atlanta, Georgia, United States, 30309
      • 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
      • West Des Moines, Iowa, United States, 50265
        • Recruiting
        • Iowa Diabetes and Endocrinology Research Center
        • Contact:
    • Louisiana
      • Marrero, Louisiana, United States, 70072
      • Monroe, Louisiana, United States, 71201
      • Shreveport, Louisiana, United States, 71105
    • Michigan
      • Clinton Township, Michigan, United States, 48038
      • Wyoming, Michigan, United States, 49519
        • Not yet recruiting
        • West Michigan Clinical Research Center
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55413
    • Missouri
      • 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
        • Not yet recruiting
        • NewYork-Presbyterian Brooklyn Methodist Hospital
        • Contact:
      • Laurelton, New York, United States, 11413
      • Rochester, New York, United States, 14642
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
      • Greenville, North Carolina, United States, 27834
      • 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
        • Not yet recruiting
        • Great Lakes Gastroenterology Research, LLC
        • Contact:
      • 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
      • Wyomissing, Pennsylvania, United States, 19610
    • South Carolina
      • 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
      • Dallas, Texas, United States, 75230
      • Dallas, Texas, United States, 75246
      • Dallas, Texas, United States, 75150
      • Denison, Texas, United States, 75020
      • Garden City, Texas, United States, 48135
        • Not yet recruiting
        • EmVenio Research Center at Prime Healthcare - Farmers Branch
        • Contact:
      • Garland, Texas, United States, 75044
      • Georgetown, Texas, United States, 78626
      • Houston, Texas, United States, 77084
      • Houston, Texas, United States, 77089
      • Houston, Texas, United States, 77030-1608
      • Lewisville, Texas, United States, 75057
      • Mansfield, Texas, United States, 76063
      • McAllen, Texas, United States, 78503
      • McAllen, Texas, United States, 78504
      • 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, 78240
      • 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
      • Richmond, Virginia, United States, 23236
    • Washington
      • Seattle, Washington, United States, 98105
      • Spokane, Washington, United States, 99218
        • Not yet recruiting
        • Velocity Clinical Research-Spokane-69716
        • Contact:

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 adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is >18 years
  2. Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)
  3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.
  4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF <5% or FibroScan® with CAP <288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis/steatohepatitis.
  5. Further inclusion criteria apply.

Exclusion criteria:

  1. Current or history (<5 years) of significant alcohol consumption, defined as an average of >140 g/week in female patients and >210 g/week in male patients, for a period of >3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.
  2. Model of end-stage liver Disease (MELD) score >12 due to liver disease

  3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:

    • Portal hypertension-related upper gastrointestinal (GI) bleeding
    • Ascites
    • Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria

  4. Any of the following lab test result at screening

    • Albumin below <3.5 g/dL (<35.0 g/L)
    • International normalised ratio (INR) >1.3 unless due to therapeutic anticoagulants
    • Total bilirubin (TBL) >1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL >1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is <20% of TBL.
    • Alkaline phosphatase >1.5x ULN
    • PLT <100,000/µL (<100 GI/L)
  5. History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis
  6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection
  7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))
  8. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5x ULN
  9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history
  10. History of liver transplantation or listed for liver transplantation
  11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment
  12. 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 matching survodutide
Subcutaneous injection, pre-filled syringe
Experimental: Survodutide
Combination product: Survodutide
Subcutaneous injection, pre-filled syringe
Other Names:
  • BI 456906

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH
Time Frame: up to 4.5 years.
MELD = model of end-stage liver disease CSPH = Clinically significant portal hypertension
up to 4.5 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage change from baseline in liver stiffness in FibroScan® VCTE
Time Frame: At baseline and at Week 76.
At baseline and at Week 76.
Time to first occurrence of progression to CSPH
Time Frame: up to 4.5 years.
up to 4.5 years.
Time to first occurrence of any of the hepatic decompensation events (ascites, HE, or portal hypertension-related upper GI bleeding), or worsening of MELD score to ≥15
Time Frame: up to 4.5 years.
up to 4.5 years.
Occurrence of all-cause hospitalisation (first and recurrent)
Time Frame: up to 4.5 years.
up to 4.5 years.
Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE)
Time Frame: up to 4.5 years.
up to 4.5 years.
Absolute changes from baseline in lipids (mg/dL)
Time Frame: At baseline and at Week 76.
At baseline and at Week 76.
Absolute change from baseline in aspartate aminotransferase (AST) (U/L)
Time Frame: At baseline and at Week 76.
At baseline and at Week 76.
Absolute change from baseline in alanine aminotransferase (ALT) (U/L)
Time Frame: At baseline and at Week 76.
At baseline and at Week 76.
Key secondary endpoint: Absolute change from baseline in enhanced liver fibrosis (ELF) score
Time Frame: At baseline and at Week 76.
At baseline and at Week 76.
Key secondary endpoint: Percentage change from baseline in body weight
Time Frame: At baseline and at Week 76.
At baseline and at Week 76.
Key secondary endpoint: Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) (%) in participants with type 2 diabetes mellitus (T2DM) at baseline
Time Frame: At baseline and at Week 76.
At baseline and at Week 76.
Key secondary endpoint: Absolute change from baseline in liver stiffness (kPa) in FibroScan® vibration-controlled transient elastography (VCTE)
Time Frame: At baseline and at Week 76.
At baseline and at Week 76.
Absolute change from baseline in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)
Time Frame: At baseline and at Week 76.
At baseline and at Week 76.

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)

November 7, 2024

Primary Completion (Estimated)

June 5, 2029

Study Completion (Estimated)

June 5, 2029

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)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1404-0064
  • 2024-513741-36-00 (Registry Identifier: CTIS (EU))
  • U1111-1307-0227 (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.

Clinical Trials on Metabolic Dysfunction Associated Steatohepatitis

Clinical Trials on Survodutide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe