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LIVERAGE™: En studie for å teste om Survodutide hjelper mennesker med en leversykdom kalt NASH/MASH som har moderat eller avansert leverfibrose

27. oktober 2026 oppdatert av: Boehringer Ingelheim

En randomisert, dobbeltblind, placebokontrollert, multisenter, fase III-studie som evaluerer langsiktig effekt og sikkerhet av ukentlige Survodutide-injeksjoner hos voksne deltakere med ikke-cirrhotisk ikke-alkoholisk Steatohepatitt/metabolsk assosiert Steatohepatitt (NASH/MASH) og (F2) (F3) Stadium av leverfibrose

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1800

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1199ABB
        • Rekruttering
        • Hospital Italiano de Buenos Aires
        • Ta kontakt med:
      • Buenos Aires, Argentina, 1061
      • Buenos Aires, Argentina, C1056ABJ
        • Rekruttering
        • Centro de Investigaciones Metabolicas (CINME)
        • Ta kontakt med:
      • Buenos Aires, Argentina, C1012AAR
        • Rekruttering
        • IDIM - Instituto de Diagnostico e Investigaciones Metabolicas
        • Ta kontakt med:
      • Buenos Aires, Argentina, C1430CKE
        • Rekruttering
        • Glenny Corp - Centro Medico Saavedra
        • Ta kontakt med:
      • Buenos Aires, Argentina, C1061AAE
        • Rekruttering
        • Buenos Aires Macula S.A.
        • Ta kontakt med:
      • Buenos Aires, Argentina, C1128AAF
        • Rekruttering
        • Mautalen- Salud e Investigacion
        • Ta kontakt med:
      • Ciudad Autonoma Buenos Aires, Argentina, C1221ADC
        • Rekruttering
        • Hospital General de Agudos Dr. J. M. Ramos Mejia
        • Ta kontakt med:
      • Pilar, Argentina, B1629ODT
        • Rekruttering
        • Hospital Universitario Austral
        • Ta kontakt med:
      • Ramos Mejía, Argentina, 1704
      • San Juan Bautista, Argentina, B1888
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Fullført
        • Concord Repatriation General Hospital
      • Kingswood, New South Wales, Australia, 2747
      • Liverpool, New South Wales, Australia, 2170
      • Westmead, New South Wales, Australia, 2145
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Rekruttering
        • Sunshine Coast University Hospital
        • Ta kontakt med:
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Heidelberg, Victoria, Australia, 3084
      • Parkville, Victoria, Australia, 3050
    • Western Australia
      • Perth, Western Australia, Australia, 6000
  • Belgia
      • Brussels, Belgia, 1070
      • Brussels, Belgia, 1200
        • Har ikke rekruttert ennå
        • Cliniques Universitaires Saint-Luc
        • Ta kontakt med:
      • Edegem, Belgia, 2650
        • Rekruttering
        • Universitair Ziekenhuis Antwerpen
        • Ta kontakt med:
      • Genk, Belgia, 3600
        • Rekruttering
        • Ziekenhuis Oost-Limburg
        • Ta kontakt med:
      • Ghent, Belgia, 9000
        • Rekruttering
        • Universitair Ziekenhuis Gent
        • Ta kontakt med:
      • Leuven, Belgia, 3000
        • Suspendert
        • UZ Leuven
      • Liège, Belgia, 4000
        • Rekruttering
        • Centre Hospitalier Universitaire de Liège
        • Ta kontakt med:
      • Namur, Belgia, 5004
        • Rekruttering
        • Clinique Saint-Luc Bouge
        • Ta kontakt med:
      • Roeselare, Belgia, 8800
  • Brasil
      • Barra, Brasil, 21941-617
        • Har ikke rekruttert ennå
        • Universidade Federal do Rio de Janeiro
        • Ta kontakt med:
      • Belo Horizonte, Brasil, 30130-100
        • Har ikke rekruttert ennå
        • Hospital das Clinicas da Universidade Federal de Minas Gerais (HC-UFMG)
        • Ta kontakt med:
      • Belém, Brasil, 66073-005
        • Rekruttering
        • Hospital Universitário João de Barros Barreto
        • Ta kontakt med:
      • Botucatu, Brasil, 18618-970
        • Rekruttering
        • Universidade Estadual Paulista "Julio De Mesquita Filho"
        • Ta kontakt med:
      • Cerqueira César, Brasil, 05403-000
        • Rekruttering
        • Hospital das Clinicas da Faculdade de Medicina da USP
        • Ta kontakt med:
      • Lago Sul, Brasil, 71625-175
        • Har ikke rekruttert ennå
        • Centro de Pesquisa Clinica do Brasil
        • Ta kontakt med:
      • Porto Alegre, Brasil, 90035-903
        • Rekruttering
        • Universidade Federal do Rio Grande do Sul
        • Ta kontakt med:
      • Porto Alegre, Brasil, 90035-001
        • Rekruttering
        • Hospitalar Moinhos de Vento
        • Ta kontakt med:
      • São José do Rio Preto, Brasil, 15090-000
        • Rekruttering
        • Hospital de Base
        • Ta kontakt med:
      • São Paulo, Brasil, 04077-020
        • Rekruttering
        • Rocco E Nazato Servicos Medicos LTDA
        • Ta kontakt med:
  • Bulgaria
      • Gorna Oryahovitsa, Bulgaria, 5100
      • Panagyurishte, Bulgaria, 4500
        • Rekruttering
        • Multi-profile Hospital For Active Treatment-Uni Hospital Ltd.
        • Ta kontakt med:
      • Sofia, Bulgaria, 1606
        • Rekruttering
        • Medical Military Academy MHAT Sofia
        • Ta kontakt med:
      • Sofia, Bulgaria, 1407
        • Rekruttering
        • Acibadem City Clinic Tokuda University Hospital EAD
        • Ta kontakt med:
      • Sofia, Bulgaria, 1431
        • Rekruttering
        • Diagnostic Consultative Center Alexandrovska
        • Ta kontakt med:
      • Sofia, Bulgaria, 1431
        • Rekruttering
        • University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
        • Ta kontakt med:
      • Stara Zagora, Bulgaria, 6001
        • Rekruttering
        • Medical Center New Rehabilitation Center EOOD
        • Ta kontakt med:
  • Canada
      • Québec, Canada, G1V 4T3
        • Rekruttering
        • Diex Recherche Québec
        • Ta kontakt med:
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Rekruttering
        • University of Calgary
        • Ta kontakt med:
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Rekruttering
        • University of British Columbia
        • Ta kontakt med:
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Rekruttering
        • Pacific Gastroenterology Associates
        • Ta kontakt med:
    • Nova Scotia
      • Bridgewater, Nova Scotia, Canada, B4N 3N2
        • Rekruttering
        • Viable Clinical Research
        • Ta kontakt med:
    • Ontario
      • Toronto, Ontario, Canada, M6H 3M1
        • Rekruttering
        • Toronto Liver Centre
        • Ta kontakt med:
    • Quebec
      • Montreal, Quebec, Canada, H3H 2R9
        • Rekruttering
        • McGill University Health Centre (MUHC)
        • Ta kontakt med:
      • Montreal, Quebec, Canada, H2X 1R9
        • Har ikke rekruttert ennå
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
        • Ta kontakt med:
      • Terrebonne, Quebec, Canada, J6X 4P7
        • Rekruttering
        • Centre de Médecine Métabolique de Lanaudière
        • Ta kontakt med:
  • Chile
      • La Serena, Chile, 1710209
        • Rekruttering
        • Edificio Fleming
        • Ta kontakt med:
      • Santiago, Chile, 8330024
        • Rekruttering
        • Centro de Investigaciones Medicas UC
        • Ta kontakt med:
      • Viña del Mar, Chile, 2540488
        • Rekruttering
        • Centro de Investigaciones Clinicas Viña del Mar
        • Ta kontakt med:
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35233
        • Har ikke rekruttert ennå
        • University of Alabama at Birmingham
        • Ta kontakt med:
    • Arizona
      • Peoria, Arizona, Forente stater, 85381
        • Rekruttering
        • The Institute for Liver Health II DBA Arizona Clinical Trials
        • Ta kontakt med:
      • Scottsdale, Arizona, Forente stater, 85258
        • Rekruttering
        • Scottsdale Medical Specialists, Ltd
        • Ta kontakt med:
      • Tucson, Arizona, Forente stater, 85712
      • Tucson, Arizona, Forente stater, 85715
      • Tucson, Arizona, Forente stater, 85712
    • California
      • Canoga Park, California, Forente stater, 91303
      • Chula Vista, California, Forente stater, 91911
        • Rekruttering
        • Velocity Clinical Research-Chula Vista
        • Ta kontakt med:
      • Coronado, California, Forente stater, 92118
        • Rekruttering
        • Southern California Research Center
        • Ta kontakt med:
      • Fountain Valley, California, Forente stater, 92708
      • Fresno, California, Forente stater, 93720
      • Gardena, California, Forente stater, 90247
        • Rekruttering
        • Velocity Clinical Research-Gardena-69773
        • Ta kontakt med:
      • Huntington Park, California, Forente stater, 90255
        • Rekruttering
        • Velocity Clinical Research-Huntington Park
        • Ta kontakt med:
      • Inglewood, California, Forente stater, 90301
      • La Mesa, California, Forente stater, 91942
        • Rekruttering
        • Velocity Clinical Research, San Diego
        • Ta kontakt med:
      • Lancaster, California, Forente stater, 93534
      • Long Beach, California, Forente stater, 90815
      • Los Angeles, California, Forente stater, 90057
        • Rekruttering
        • Velocity Clinical Research, Westlake
        • Ta kontakt med:
      • Montclair, California, Forente stater, 91763
      • Orange, California, Forente stater, 92868
      • Oxnard, California, Forente stater, 93030
      • Pasadena, California, Forente stater, 91105
        • Rekruttering
        • California Liver Research Institute
        • Ta kontakt med:
      • Poway, California, Forente stater, 92064
      • Poway, California, Forente stater, 92064
      • Rialto, California, Forente stater, 92377
      • San Bernardino, California, Forente stater, 92404
      • San Diego, California, Forente stater, 92123
        • Har ikke rekruttert ennå
        • Medical Associates Research Group, Inc.
        • Ta kontakt med:
      • San Diego, California, Forente stater, 92120
      • Santa Ana, California, Forente stater, 92704
        • Avsluttet
        • Velocity Clinical Research, Santa Ana
      • Van Nuys, California, Forente stater, 91405
        • Rekruttering
        • Velocity Clinical Research, Van Nuys
        • Ta kontakt med:
      • Victorville, California, Forente stater, 92395
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80907
      • Englewood, Colorado, Forente stater, 80113
    • Connecticut
      • Bristol, Connecticut, Forente stater, 06010
        • Rekruttering
        • Connecticut Gastroenterology Clinical Research Foundation
        • Ta kontakt med:
      • New Haven, Connecticut, Forente stater, 06520
    • Florida
      • Altamonte Springs, Florida, Forente stater, 32714
      • Bradenton, Florida, Forente stater, 34209
      • Brandon, Florida, Forente stater, 33511
      • Brooksville, Florida, Forente stater, 34613
      • Clearwater, Florida, Forente stater, 33761
      • Clermont, Florida, Forente stater, 34711
        • Rekruttering
        • K2 Medical Research - Winter Garden
        • Ta kontakt med:
      • Coral Gables, Florida, Forente stater, 33134
      • Cutler Bay, Florida, Forente stater, 33189
      • Fort Myers, Florida, Forente stater, 33912
        • Rekruttering
        • Covenant Metabolic Specialists, LLC - Fort Myers
        • Ta kontakt med:
      • Gainesville, Florida, Forente stater, 32610
      • Hialeah, Florida, Forente stater, 33016
      • Hialeah Gardens, Florida, Forente stater, 33016
      • Homestead, Florida, Forente stater, 33030
      • Lady Lake, Florida, Forente stater, 32159
      • Lakewood Rch, Florida, Forente stater, 34211
      • Maitland, Florida, Forente stater, 32751
      • Miami, Florida, Forente stater, 33176
      • Miami, Florida, Forente stater, 33134
        • Rekruttering
        • Research Associates of South Florida, LLC
        • Ta kontakt med:
      • Miami, Florida, Forente stater, 33135
      • Miami, Florida, Forente stater, 33176
      • Miami, Florida, Forente stater, 33156
      • Miami, Florida, Forente stater, 33136
      • Miami Lakes, Florida, Forente stater, 33016
      • Naples, Florida, Forente stater, 34102
      • Orlando, Florida, Forente stater, 32803
      • Orlando, Florida, Forente stater, 32828
      • Orlando, Florida, Forente stater, 32806
        • Avsluttet
        • K2 Medical Research
      • Palmetto Bay, Florida, Forente stater, 33157
      • Pembroke Pines, Florida, Forente stater, 33024
        • Rekruttering
        • MplusM - Best Choice Medical and Research Service
        • Ta kontakt med:
      • Port Orange, Florida, Forente stater, 32127
      • Riverview, Florida, Forente stater, 33578
        • Rekruttering
        • Covenant Metabolic Specialist, LLC - Riverview
        • Ta kontakt med:
      • St. Petersburg, Florida, Forente stater, 33714
      • Tampa, Florida, Forente stater, 33618
      • The Villages, Florida, Forente stater, 32162
      • University Park, Florida, Forente stater, 34201
        • Rekruttering
        • Covenant Metabolic Specialists, LLC - University Park
        • Ta kontakt med:
      • Winter Park, Florida, Forente stater, 32789
      • Zephyrhills, Florida, Forente stater, 33542
    • Georgia
      • Macon, Georgia, Forente stater, 31201
        • Rekruttering
        • Gastroenterology Associates of Central Georgia
        • Ta kontakt med:
      • Riverdale, Georgia, Forente stater, 30274
        • Rekruttering
        • EmVenio Research Center at Prime Healthcare - Riverdale
        • Ta kontakt med:
    • Indiana
      • Hammond, Indiana, Forente stater, 46324
        • Rekruttering
        • ASHA Clinical Research - Munster, LLC
        • Ta kontakt med:
      • South Bend, Indiana, Forente stater, 46635
        • Rekruttering
        • Digestive Research Alliance of Michiana
        • Ta kontakt med:
    • Iowa
      • Clive, Iowa, Forente stater, 50325
      • West Des Moines, Iowa, Forente stater, 50265
        • Rekruttering
        • Iowa Diabetes and Endocrinology Research Center
        • Ta kontakt med:
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • Har ikke rekruttert ennå
        • University of Kansas Medical Center
        • Ta kontakt med:
      • Topeka, Kansas, Forente stater, 66606
    • Louisiana
      • Bastrop, Louisiana, Forente stater, 71220
      • Marrero, Louisiana, Forente stater, 70072
      • Shreveport, Louisiana, Forente stater, 71105
    • Maryland
      • Baltimore, Maryland, Forente stater, 21202
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
    • Michigan
      • Clinton Township, Michigan, Forente stater, 48038
        • Rekruttering
        • Clinical Research Institute of Michigan, LLC
        • Ta kontakt med:
      • Wyoming, Michigan, Forente stater, 49519
        • Rekruttering
        • West Michigan Clinical Research Center
        • Ta kontakt med:
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55413
    • Mississippi
      • Flowood, Mississippi, Forente stater, 39232
    • Missouri
      • Chesterfield, Missouri, Forente stater, 63005
      • Columbia, Missouri, Forente stater, 65201
        • Rekruttering
        • ObjectiveHealth-GI Associates Research
        • Ta kontakt med:
      • Kansas City, Missouri, Forente stater, 64131
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68198
        • Rekruttering
        • University of Nebraska Medical Center
        • Ta kontakt med:
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89106
      • Las Vegas, Nevada, Forente stater, 89121
      • Las Vegas, Nevada, Forente stater, 89109
    • New Jersey
      • Warren Township, New Jersey, Forente stater, 07059
    • New York
      • Brooklyn, New York, Forente stater, 11215
        • Rekruttering
        • NewYork-Presbyterian Brooklyn Methodist Hospital
        • Ta kontakt med:
      • Laurelton, New York, Forente stater, 11413
      • New York, New York, Forente stater, 10029
        • Har ikke rekruttert ennå
        • Icahn School of Medicine at Mount Sinai
        • Ta kontakt med:
      • Rochester, New York, Forente stater, 14642
        • Rekruttering
        • University of Rochester Medical Center
        • Ta kontakt med:
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Har ikke rekruttert ennå
        • Duke University Medical Center
        • Ta kontakt med:
      • Fayetteville, North Carolina, Forente stater, 28304
      • Greenville, North Carolina, Forente stater, 27834
      • New Bern, North Carolina, Forente stater, 28562
      • Raleigh, North Carolina, Forente stater, 27612
    • Ohio
      • Columbus, Ohio, Forente stater, 43210
        • Rekruttering
        • The Ohio State University Wexner Medical Center
        • Ta kontakt med:
      • Mentor, Ohio, Forente stater, 44060
      • Springboro, Ohio, Forente stater, 45066
        • Rekruttering
        • ObjectiveHealth-DSI Research - Springboro, LLC
        • Ta kontakt med:
      • Westlake, Ohio, Forente stater, 44145
        • Rekruttering
        • Northshore Gastroenterology Research
        • Ta kontakt med:
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74104
    • Pennsylvania
      • Flourtown, Pennsylvania, Forente stater, 19031
      • Hershey, Pennsylvania, Forente stater, 17033
        • Rekruttering
        • Penn State Milton S. Hershey Medical Center
        • Ta kontakt med:
      • Lancaster, Pennsylvania, Forente stater, 17601
      • State College, Pennsylvania, Forente stater, 16801
      • Wyomissing, Pennsylvania, Forente stater, 19610
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Rekruttering
        • Medical University of South Carolina
        • Ta kontakt med:
      • Columbia, South Carolina, Forente stater, 29204
        • Rekruttering
        • ObjectiveHealth-Columbia Digestive Health Research
        • Ta kontakt med:
      • Summerville, South Carolina, Forente stater, 29485
    • Tennessee
      • Chattanooga, Tennessee, Forente stater, 37421
      • Clarksville, Tennessee, Forente stater, 37040
      • Nashville, Tennessee, Forente stater, 37232
        • Rekruttering
        • Vanderbilt University Medical Center
        • Ta kontakt med:
    • Texas
      • Arlington, Texas, Forente stater, 76012
        • Rekruttering
        • Texas Clinical Research Institute, LLC
        • Ta kontakt med:
      • Austin, Texas, Forente stater, 78757
        • Rekruttering
        • Pinnacle Clinical Research - Austin
        • Ta kontakt med:
      • Austin, Texas, Forente stater, 78759
      • Austin, Texas, Forente stater, 78745
      • Austin, Texas, Forente stater, 78757
        • Rekruttering
        • American Research Corporation - Austin
        • Ta kontakt med:
      • Bellaire, Texas, Forente stater, 77401
      • Brownsville, Texas, Forente stater, 78520
        • Rekruttering
        • South Texas Research Institute - Brownsville
        • Ta kontakt med:
      • Carrollton, Texas, Forente stater, 75006
      • Corpus Christi, Texas, Forente stater, 78404
        • Rekruttering
        • Pinnacle Clinical Research - Corpus Christi
        • Ta kontakt med:
      • Dallas, Texas, Forente stater, 75230
      • Dallas, Texas, Forente stater, 75246
      • Dallas, Texas, Forente stater, 75230
        • Rekruttering
        • Velocity Clinical Research-Dallas-69170
        • Ta kontakt med:
      • Dallas, Texas, Forente stater, 75150
      • DeSoto, Texas, Forente stater, 75115
      • Denison, Texas, Forente stater, 75020
      • Edinburg, Texas, Forente stater, 78539
        • Rekruttering
        • South Texas Research Institute-Edinburg-67012
        • Ta kontakt med:
      • Forney, Texas, Forente stater, 75126
      • Garden City, Texas, Forente stater, 48135
        • Rekruttering
        • EmVenio Research Center at Prime Healthcare - Farmers Branch
        • Ta kontakt med:
      • Garland, Texas, Forente stater, 75043
      • Georgetown, Texas, Forente stater, 78626
      • Houston, Texas, Forente stater, 77084
        • Rekruttering
        • Biopharma Informatic, Inc. Research Center
        • Ta kontakt med:
      • Houston, Texas, Forente stater, 77089
      • Houston, Texas, Forente stater, 77030-1608
      • Houston, Texas, Forente stater, 77004
      • Lewisville, Texas, Forente stater, 75057
      • Mansfield, Texas, Forente stater, 76063
      • McAllen, Texas, Forente stater, 78503
      • McAllen, Texas, Forente stater, 78504
      • Plano, Texas, Forente stater, 75093
      • San Antonio, Texas, Forente stater, 78215
        • Rekruttering
        • American Research Corporation at the Texas Liver Institute
        • Ta kontakt med:
      • San Antonio, Texas, Forente stater, 78219
      • San Antonio, Texas, Forente stater, 78229
      • San Antonio, Texas, Forente stater, 78229
      • San Antonio, Texas, Forente stater, 78240
      • San Antonio, Texas, Forente stater, 78222
        • Rekruttering
        • Pinnacle Clinical Research - San Antonio
        • Ta kontakt med:
      • Waco, Texas, Forente stater, 76710
      • Waco, Texas, Forente stater, 76712
        • Rekruttering
        • Objective Health-Digestive Research of Central Texas
        • Ta kontakt med:
      • Wichita Falls, Texas, Forente stater, 76301
        • Rekruttering
        • ObjectiveHealth-Digestive Health Research of North Texas
        • Ta kontakt med:
    • Virginia
      • Newport News, Virginia, Forente stater, 23601
        • Har ikke rekruttert ennå
        • Liver Institute of Virginia-Bremo
        • Ta kontakt med:
      • Richmond, Virginia, Forente stater, 23236
      • Richmond, Virginia, Forente stater, 23298
    • Washington
      • Seattle, Washington, Forente stater, 98105
        • Rekruttering
        • Velocity Clinical Research, Seattle
        • Ta kontakt med:
      • Spokane, Washington, Forente stater, 99218
        • Rekruttering
        • Velocity Clinical Research-Spokane-69716
        • Ta kontakt med:
  • Frankrike
      • Amiens, Frankrike, 80054
        • Har ikke rekruttert ennå
        • CHU Amiens-Picardie
        • Ta kontakt med:
      • Angers, Frankrike, 49100
        • Har ikke rekruttert ennå
        • Centre Hospitalier Universitaire D'Angers
        • Ta kontakt med:
      • Clichy, Frankrike, 92110
        • Har ikke rekruttert ennå
        • Hopital Beaujon
        • Ta kontakt med:
      • Créteil, Frankrike, 94000
        • Har ikke rekruttert ennå
        • Hopital Henri Mondor
        • Ta kontakt med:
      • Dijon, Frankrike, 21000
        • Har ikke rekruttert ennå
        • HOP Dijon-Bourgogne
        • Ta kontakt med:
      • Le Chesnay, Frankrike, 78150
        • Har ikke rekruttert ennå
        • Centre Hospitalier De Versailles
        • Ta kontakt med:
      • Lille, Frankrike, 59000
        • Har ikke rekruttert ennå
        • Hôpital Claude Huriez
        • Ta kontakt med:
      • Lyon, Frankrike, 69004
        • Har ikke rekruttert ennå
        • Hopital De La Croix-Rousse
        • Ta kontakt med:
      • Nice, Frankrike, 06200
        • Har ikke rekruttert ennå
        • Hôpital de l'Archet
        • Ta kontakt med:
      • Paris, Frankrike, 75014
        • Har ikke rekruttert ennå
        • Hôpital Cochin
        • Ta kontakt med:
      • Paris, Frankrike, 75013
        • Har ikke rekruttert ennå
        • Hopitaux Universitaires Pitié-Salpétrière
        • Ta kontakt med:
      • Pessac, Frankrike, 33600
        • Har ikke rekruttert ennå
        • Centre Hospitalier Universitaire De Bordeaux
        • Ta kontakt med:
      • Pierre-Bénite, Frankrike, 69495
        • Har ikke rekruttert ennå
        • Centre Hospitalier Lyon Sud
        • Ta kontakt med:
      • Toulouse, Frankrike, 31059
        • Har ikke rekruttert ennå
        • Hôpital Rangueil - CHU de Toulouse
        • Ta kontakt med:
  • Georgia
      • Batumi, Georgia, 6010
      • Tbilisi, Georgia, 0112
        • Rekruttering
        • Israeli - Georgian Medical Research Clinic Healthycore LTD
        • Ta kontakt med:
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Rekruttering
        • Prince Of Wales Hospital
        • Ta kontakt med:
  • India
      • Ahemdabad, India, 380060
        • Rekruttering
        • Aryav Superspeciality Hospital
        • Ta kontakt med:
      • Chandigarh, India, 14209-1120
        • Rekruttering
        • Post Graduate Institute of Medical Education and Research
        • Ta kontakt med:
      • Hyderabad, Afzalgunj, India, 500012
        • Rekruttering
        • Osmania Medical College & Hospital
        • Ta kontakt med:
      • Jaipur, India, 302001
        • Rekruttering
        • SR Kalla Memorial Hospital
        • Ta kontakt med:
      • Jaipur, India, 302020
        • Rekruttering
        • ManglamPlus Medicity Hospital
        • Ta kontakt med:
      • Lucknow, India, 226003
        • Rekruttering
        • Atharva Multispecialty Hospital and research Centre
        • Ta kontakt med:
      • Mohali, India, 160062
        • Rekruttering
        • Fortis Hospital, Mohali
        • Ta kontakt med:
      • Nagpur, India, 440010
        • Rekruttering
        • Midas Multispeciality Hospital Pvt. Ltd.
        • Ta kontakt med:
      • New Delhi, India, 110029
        • Rekruttering
        • All India Institute of Medical Sciences
        • Ta kontakt med:
      • New Delhi, India, 110 070
        • Rekruttering
        • Insitute of Liver and Billiary Sciences
        • Ta kontakt med:
      • Rohtak, India, 124001
        • Rekruttering
        • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
        • Ta kontakt med:
      • Secunderabad, India, 500003
        • Rekruttering
        • Yashoda Hospitals - Secunderabad
        • Ta kontakt med:
      • Surat, India, 395002
        • Rekruttering
        • Surat Institute of Digestive Sciences
        • Ta kontakt med:
      • Surat, India, 395009
        • Rekruttering
        • Gujarat Gastro and Vascular Hospital
        • Ta kontakt med:
      • Surat, India, 395009
        • Rekruttering
        • BAPS Pramukh Swami Hospital
        • Ta kontakt med:
  • Italia
      • Bologna, Italia, 40138
        • Rekruttering
        • Policlinico S. Orsola-Malpighi
        • Ta kontakt med:
      • Foggia, Italia, 71122
        • Rekruttering
        • Az.Osp. Universitaria "Ospedali Riuniti"
        • Ta kontakt med:
      • Milan, Italia, 20122
        • Rekruttering
        • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
        • Ta kontakt med:
      • Modena, Italia, 41121
        • Rekruttering
        • Università di Modena e Reggio Emilia
        • Ta kontakt med:
      • Novara, Italia, 28100
        • Har ikke rekruttert ennå
        • Ospedale Maggiore della Carità
        • Ta kontakt med:
      • Palermo, Italia, 90127
        • Rekruttering
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
        • Ta kontakt med:
      • Rome, Italia, 00168
        • Rekruttering
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Ta kontakt med:
      • Rome, Italia, 00128
        • Rekruttering
        • Fondazione Policlinico Universitario Campus Bio-medico
        • Ta kontakt med:
      • Rozzano, Italia, 20089
        • Rekruttering
        • Istituto Clinico Humanitas
        • Ta kontakt med:
      • San Giovanni Rotondo, Italia, 71013
        • Rekruttering
        • IRCCS Ospedale "Casa Sollievo della Sofferenza"
        • Ta kontakt med:
      • Torino, Italia, 10126
        • Rekruttering
        • Universita Degli Studi di Torino
        • Ta kontakt med:
      • Verona, Italia, 37134
        • Rekruttering
        • Azienda Ospedaliera Universitaria Integrata Verona
        • Ta kontakt med:
  • Japan
      • Bunkyō City, Japan, 113-8655
        • Rekruttering
        • The University of Tokyo Hospital
        • Ta kontakt med:
      • Chiba, Japan, 260-8677
        • Rekruttering
        • Chiba University Hospital
        • Ta kontakt med:
      • Chiba, Ichikawa, Japan, 272-8516
        • Rekruttering
        • Japan Institute for Health Security National Kohnodai Medical Center
        • Ta kontakt med:
      • Ehime, Toon, Japan, 791-0295
        • Rekruttering
        • Ehime University Hospital
        • Ta kontakt med:
      • Fukui-shi, Japan, 918-8503
        • Rekruttering
        • Fukuiken Saiseikai Hospital
        • Ta kontakt med:
      • Fukuoka, Fukuoka, Japan, 810-8563
        • Rekruttering
        • National Hospital Organization Kyushu Medical Center
        • Ta kontakt med:
      • Fukuoka, Kurume, Japan, 830-0011
        • Rekruttering
        • Kurume University Hospital
        • Ta kontakt med:
      • Gifu, Gifu, Japan, 500-8513
        • Rekruttering
        • Gifu Municipal Hospital
        • Ta kontakt med:
      • Hanishina-gun, Japan, 381-8551
        • Rekruttering
        • Nagano Municipal Hospital
        • Ta kontakt med:
      • Hiroshima, Japan, 734-8551
        • Rekruttering
        • Hiroshima University Hospital
        • Ta kontakt med:
      • Hiroshima, Japan, 730-8619
        • Rekruttering
        • Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital
        • Ta kontakt med:
      • Hokkaido, Sapporo, Japan, 062-8618
        • Rekruttering
        • Japan Community Health Care Organization Hokkaido Hospital
        • Ta kontakt med:
      • Hyogo, Nishinomiya, Japan, 663-8501
        • Rekruttering
        • Hyogo College of Medicine Hospital
        • Ta kontakt med:
      • Ibaraki, Inashiki-gun, Japan, 300-0395
        • Rekruttering
        • Tokyo Medical University Ibaraki Medical Center
        • Ta kontakt med:
      • Isehara-shi, Japan, 259-1193
        • Rekruttering
        • Tokai University Hospital
        • Ta kontakt med:
      • Ishikawa, Kanazawa, Japan, 920-8641
        • Rekruttering
        • Kanazawa University Hospital
        • Ta kontakt med:
      • Izumo, Japan, 693-8501
        • Rekruttering
        • Shimane University Hospital
        • Ta kontakt med:
      • Kagoshima, Japan, 890-8520
        • Rekruttering
        • Kagoshima University Hospital
        • Ta kontakt med:
      • Kanagawa, Kawasaki, Japan, 215-0026
        • Rekruttering
        • Shin-yurigaoka General Hospital
        • Ta kontakt med:
      • Kawasaki-shi, Japan, 216-8511
        • Rekruttering
        • St. Marianna University Hospital
        • Ta kontakt med:
      • Kita-gun, Japan, 761-0793
        • Rekruttering
        • Kagawa University Hospital
        • Ta kontakt med:
      • Kobe, Japan, 650-0017
        • Rekruttering
        • Kobe University Hospital
        • Ta kontakt med:
      • Kumamoto, Japan, 860-8556
        • Rekruttering
        • Kumamoto University Hospital
        • Ta kontakt med:
      • Kumamoto, Japan, 862-8655
        • Rekruttering
        • Kumamoto Shinto General Hospital
        • Ta kontakt med:
      • Kure, Japan, 737-0023
        • Rekruttering
        • National Hospital Organization Kure Medical Center and Chugoku Cancer Center
        • Ta kontakt med:
      • Kyoto, Japan, 602-8566
        • Rekruttering
        • University Hospital Kyoto Prefectural University of Medicine
        • Ta kontakt med:
      • Miyazaki, Japan, 889-1692
        • Rekruttering
        • University of Miyazaki Hospital
        • Ta kontakt med:
      • Musashino, Japan, 186-8610
        • Rekruttering
        • Japanese Red Cross Musashino Hospital
        • Ta kontakt med:
      • Nagano, Matsumoto, Japan, 390-8621
        • Rekruttering
        • Shinshu University Hospital
        • Ta kontakt med:
      • Nagasaki, Omura, Japan, 856-8562
        • Rekruttering
        • Nagasaki Medical Center
        • Ta kontakt med:
      • Nara, Kashihara, Japan, 634-8522
        • Rekruttering
        • Nara Medical University Hospital
        • Ta kontakt med:
      • Narita, Japan, 286-0105
        • Rekruttering
        • International University of Health and Welfare Narita Hospital
        • Ta kontakt med:
      • Niigata, Japan, 951-8520
        • Rekruttering
        • Niigata University Medical and Dental Hospital
        • Ta kontakt med:
      • Okayama, Japan, 700-8558
        • Rekruttering
        • Okayama University Hospital
        • Ta kontakt med:
      • Osaka, Japan, 545-0051
        • Rekruttering
        • Osaka City University Hospital
        • Ta kontakt med:
      • Saga, Japan, 849-8501
        • Rekruttering
        • Saga University Hospital
        • Ta kontakt med:
      • Sakai, Japan, 591-8025
        • Rekruttering
        • Osaka Rosai Hospital
        • Ta kontakt med:
      • Sakai, Japan, 599-8247
        • Rekruttering
        • Seichokai Bell Land General Hospital
        • Ta kontakt med:
      • Sapporo, Japan, 060-0033
        • Rekruttering
        • Sapporo Kosei General Hospital
        • Ta kontakt med:
      • Sendai, Japan, 981-3116
        • Rekruttering
        • Sendai Tokushukai Hospital
        • Ta kontakt med:
      • Shimonoseki, Japan, 750-0061
        • Rekruttering
        • JCHO Shimonoseki Medical Center
        • Ta kontakt med:
      • Shiwa-gun, Japan, 028-3695
        • Har ikke rekruttert ennå
        • Iwate Medical University Hospital
        • Ta kontakt med:
      • Shizuoka, Hamamatsu, Japan, 431-3192
        • Rekruttering
        • Hamamatsu University Hospital
        • Ta kontakt med:
      • Shizuoka, Izunokuni, Japan, 410-2295
        • Rekruttering
        • Juntendo University Shizuoka Hospital
        • Ta kontakt med:
      • Suita-Shi, Japan, 564-0013
        • Rekruttering
        • Suita Hospital
        • Ta kontakt med:
      • Suita-shi, Japan, 565-0871
        • Rekruttering
        • The University of Osaka Hospital
        • Ta kontakt med:
      • Takasaki-shi, Japan, 370-0829
        • Rekruttering
        • National Hospital Organization Takasaki General Medical Center
        • Ta kontakt med:
      • Tokyo, Japan, 173-8610
        • Rekruttering
        • Nihon University Itabashi Hospital
        • Ta kontakt med:
      • Tokyo, Japan, 160-0023
        • Rekruttering
        • Tokyo Medical University Hospital
        • Ta kontakt med:
      • Tokyo, Japan, 113-8519
        • Rekruttering
        • Institute of Science Tokyo Hospital
        • Ta kontakt med:
      • Tokyo, Bunkyo-ku, Japan, 113-8603
        • Rekruttering
        • Nippon Medical School Hospital
        • Ta kontakt med:
      • Tokyo, Minato-ku, Japan, 105-8470
        • Rekruttering
        • Toranomon Hospital
        • Ta kontakt med:
      • Toyoake-shi, Japan, 470-1192
        • Rekruttering
        • Fujita Health University Hospital
        • Ta kontakt med:
      • Tsu, Japan, 514-8507
        • Rekruttering
        • Mie University Hospital
        • Ta kontakt med:
      • Wakayama, Japan, 641-8509
        • Rekruttering
        • Wakayama Medical University Hospital
        • Ta kontakt med:
      • Yokohama, Japan, 236-0004
        • Rekruttering
        • Yokohama City University Hospital
        • Ta kontakt med:
      • Ōita, Japan, 870-0837
        • Rekruttering
        • Oita Cardiovascular Hospital
        • Ta kontakt med:
  • Jordan
      • Amman, Jordan, 11194
        • Rekruttering
        • The Speciality Hospital (TSH)
        • Ta kontakt med:
      • Irbid, Jordan, 21110
        • Rekruttering
        • Irbid Specialty Hospital
        • Ta kontakt med:
      • Jordan, Jordan, 13046
        • Rekruttering
        • Jordan University Hospital
        • Ta kontakt med:
  • Kasakhstan
      • Almaty, Kasakhstan, 050000
        • Rekruttering
        • Asfendiyarov Kazakh National Medical University
        • Ta kontakt med:
      • Almaty, Kasakhstan, 050026
        • Rekruttering
        • Institute of Gastroenterology, Hepatology and Metabolism LLP
        • Ta kontakt med:
  • Kina
      • Beijing, Kina, 100050
        • Rekruttering
        • Beijing Friendship Hospital
        • Ta kontakt med:
      • Beijing, Kina, 100044
        • Rekruttering
        • Peking University People's Hospital
        • Ta kontakt med:
      • Beijing, Kina, 102218
        • Rekruttering
        • Beijing Tsinghua Changgung Hospital
        • Ta kontakt med:
      • Beijing, Kina, 100015
        • Rekruttering
        • Beijing Ditan Hospital Capital Medical University
        • Ta kontakt med:
      • Beijing, Kina, 100069
        • Rekruttering
        • Beijing Youan Hospital, Capital Medical University
        • Ta kontakt med:
      • Changchun, Kina, 130021
        • Rekruttering
        • The First Hospital of Jilin University
        • Ta kontakt med:
      • Changsha, Kina, 410008
        • Rekruttering
        • Xiangya Hospital, Central South University
        • Ta kontakt med:
      • Changsha, Kina, 410005
        • Rekruttering
        • Hunan Provincial People's Hospital
        • Ta kontakt med:
      • Changzhou Shi, Kina, 214442
        • Rekruttering
        • Changzhou Third People's Hospital
        • Ta kontakt med:
      • Chengdu, Kina, 610041
        • Rekruttering
        • West China Hospital, Sichuan University
        • Ta kontakt med:
      • Chongqing, Kina, 404000
        • Rekruttering
        • Chongqing Three Gorges Central Hospital
        • Ta kontakt med:
      • Foshan, Kina, 528000
        • Rekruttering
        • The First People's Hospital of Foshan
        • Ta kontakt med:
      • Fuzhou, Kina, 350005
        • Rekruttering
        • The First Affiliated Hospital of Fujian Medical University
        • Ta kontakt med:
      • Fuzhou, Kina, 350025
        • Rekruttering
        • Mengchao Hepatobiliary Hospital of Fujian Medical University
        • Ta kontakt med:
      • Guangzhou, Kina, 510515
        • Rekruttering
        • NanFang Hosptial
        • Ta kontakt med:
      • Guangzhou, Kina, 510630
        • Rekruttering
        • The third affiliated hospital of Sun Yat-Sen University
        • Ta kontakt med:
      • Guangzhou, Kina, 510000
        • Rekruttering
        • Guangzhou Eighth People's Hospital,Guangzhou Medical University
        • Ta kontakt med:
      • Guangzhou, Kina, 510013
        • Rekruttering
        • Guangzhou First People's Hospital
        • Ta kontakt med:
      • Guangzhou, Kina, 510080
        • Rekruttering
        • The First Affiliated Hospital,Sun Yat-sen University
        • Ta kontakt med:
      • Guiyang, Kina, 550002
        • Rekruttering
        • Guizhou Provincial People's Hospital
        • Ta kontakt med:
      • Hangzhou, Kina, 310013
        • Rekruttering
        • Zhejiang Hospital
        • Ta kontakt med:
      • Hangzhou, Kina, 310015
        • Rekruttering
        • The Affiliated Hospital of Hangzhou Normal University
        • Ta kontakt med:
      • Hangzhou, Kina, 310003
        • Rekruttering
        • The First Affiliated Hospital, Zhejiang University
        • Ta kontakt med:
      • Hangzhou, Kina, 310016
        • Rekruttering
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
        • Ta kontakt med:
      • Jiaxing, Kina, 314001
        • Rekruttering
        • The First Hospital of Jiaxing
        • Ta kontakt med:
      • Liaocheng, Kina, 252000
        • Rekruttering
        • Liaocheng People's Hospital
        • Ta kontakt med:
      • Luoyang, Kina, 471003
        • Rekruttering
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Ta kontakt med:
      • Nanchang, Kina, 330006
        • Rekruttering
        • The First Affiliated Hospital of Nanchang University
        • Ta kontakt med:
      • Nanchang, Kina, 330006
        • Rekruttering
        • The Second Affiliated Hospital to Nanchang University
        • Ta kontakt med:
      • Nanjing, Kina, 210008
        • Rekruttering
        • Nanjing Drum Tower Hospital
        • Ta kontakt med:
      • Nanjing, Kina, 210003
        • Rekruttering
        • The Second Hospital of Nanjing
        • Ta kontakt med:
      • Ningbo, Kina, 315010
        • Rekruttering
        • Ningbo Second Hospital
        • Ta kontakt med:
      • Ningxia, Kina, 750004
        • Rekruttering
        • General Hospital of Ningxia Medical University
        • Ta kontakt med:
      • Pingxiang, Kina, 337000
        • Rekruttering
        • Pingxiang People's Hospital
        • Ta kontakt med:
      • Qingdao, Kina, 266001
        • Rekruttering
        • Qingdao Municipal Hospital
        • Ta kontakt med:
      • Shanghai, Kina, 200120
        • Rekruttering
        • Shanghai East Hospital
        • Ta kontakt med:
      • Shanghai, Kina, 201508
        • Rekruttering
        • Shanghai Public Health Clinical Center
        • Ta kontakt med:
      • Shanghai, Kina, 200040
        • Rekruttering
        • Huashan Hospital, Fudan University
        • Ta kontakt med:
      • Shanghai, Kina, 200080
        • Rekruttering
        • Shanghai General Hospital
        • Ta kontakt med:
      • Shanghai, Kina, 200025
        • Rekruttering
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
        • Ta kontakt med:
      • Shanghai, Kina, 200127
        • Rekruttering
        • Renji Hospital Shanghai Jiaotong University School of Medicine
        • Ta kontakt med:
      • Shenyang, Kina, 110006
        • Rekruttering
        • The Sixth People's Hospital of Shenyang
        • Ta kontakt med:
      • Shenzhen, Kina, 518112
        • Rekruttering
        • The Third People's Hospital of Shenzhen
        • Ta kontakt med:
      • Suzhou, Kina, 215007
        • Rekruttering
        • The Fifth People's Hospital of Suzhou
        • Ta kontakt med:
      • Tianjin, Kina, 300192
        • Rekruttering
        • Tianjin Second People's Hospital
        • Ta kontakt med:
      • Tianjin, Kina, 300170
        • Rekruttering
        • Tianjin Third Central Hospital
        • Ta kontakt med:
      • Wenzhou, Kina, 325000
        • Rekruttering
        • The First Affiliated Hospital of Wenzhou Medical University
        • Ta kontakt med:
      • Wuhan, Kina, 430060
        • Rekruttering
        • Renmin Hospital of Wuhan University
        • Ta kontakt med:
      • Wuhan, Kina, 430022
        • Rekruttering
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Ta kontakt med:
      • Wuxi, Kina, 214005
        • Rekruttering
        • Wuxi No. 5 People's Hospital
        • Ta kontakt med:
      • Xi'an, Kina, 710061
        • Rekruttering
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Ta kontakt med:
      • Xi'an, Kina, 710004
        • Rekruttering
        • Second Affiliated Hospital of medical college of Xi'an JiaoTong University
        • Ta kontakt med:
      • Xuzhou, Kina, 221002
        • Rekruttering
        • The Affiliated Hospital of Xuzhou Medical College
        • Ta kontakt med:
      • Yanji, Kina, 133000
        • Rekruttering
        • Yanbian University Hospital
        • Ta kontakt med:
      • Yueyang, Kina, 414000
        • Rekruttering
        • Yueyang Central Hospital
        • Ta kontakt med:
      • Yuncheng, Kina, 44099
        • Rekruttering
        • Yuncheng Center Hopsital
        • Ta kontakt med:
      • Zhengzhou, Kina, 450005
        • Rekruttering
        • Sixth People's Hospital of Zhengzhou
        • Ta kontakt med:
      • Zhenjiang, Kina, 212021
        • Rekruttering
        • The Third People's Hospital of Zhenjiang
        • Ta kontakt med:
  • Malaysia
      • Ampang, Malaysia, 68000
      • Kota Bharu, Malaysia, 16150
        • Rekruttering
        • Hospital Universiti Sains Malaysia
        • Ta kontakt med:
      • Kuala Lumpur, Malaysia, 59100
        • Rekruttering
        • University Malaya Medical Centre
        • Ta kontakt med:
      • Putrajaya, Malaysia, 0000
        • Rekruttering
        • Queen Elizabeth Hospital
        • Ta kontakt med:
  • Mexico
      • Acapulco de Juárez, Mexico, 39670
        • Rekruttering
        • Centro de Investigacion Clinica del Pacifico (CICPA)
        • Ta kontakt med:
      • Col. Xoco, Mexico, 03339
        • Rekruttering
        • Centro de Investigación y Gastroenterología
        • Ta kontakt med:
      • Cuernavaca, Mexico, 62250
        • Rekruttering
        • Instituto de Diabetes, Obesidad y Nutrición S.C.
        • Ta kontakt med:
      • Mexico City, Mexico, 03300
        • Rekruttering
        • Clinicos Asociados BOCM SC
        • Ta kontakt med:
      • Mexico City, Mexico, 06700
        • Rekruttering
        • Centro de Investigación y Gastroenterología
        • Ta kontakt med:
      • Mérida, Mexico, 97070
        • Rekruttering
        • Medical Care and Research
        • Ta kontakt med:
      • Veracruz, Mexico, 91910
        • Rekruttering
        • Practice Dr Rosa Isela Luna Ceballos
        • Ta kontakt med:
      • Xalapa, Mexico, 91020
        • Rekruttering
        • Centro de Alta Especialidad del Estado de Veracruz
        • Ta kontakt med:
  • Nederland
      • Amsterdam, Nederland, 1081HV
        • Rekruttering
        • Amsterdam UMC Locatie VUMC
        • Ta kontakt med:
      • Dordrecht, Nederland, 3318 AT
        • Rekruttering
        • Albert SchweitzerZiekenhuis
        • Ta kontakt med:
      • Nijmegen, Nederland, 6525 GA
        • Rekruttering
        • Radboud Universitair Medisch Centrum
        • Ta kontakt med:
      • Rotterdam, Nederland, 3015 GD
      • Schiedam, Nederland, 3118 JH
      • Tilburg, Nederland, 5042 AD
        • Rekruttering
        • Tweesteden Ziekenhuis, locatie Tilburg
        • Ta kontakt med:
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1010
        • Rekruttering
        • New Zealand Clinical Research (NZCR)
        • Ta kontakt med:
      • Papatoetoe, Auckland, New Zealand, 2025
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8140
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3240
  • Polen
      • Krakow, Polen, 31-501
        • Rekruttering
        • Medical Centre FutureMeds Krakow
        • Ta kontakt med:
      • Lodz, Polen, 91-363
        • Rekruttering
        • FutureMeds Lodz
        • Ta kontakt med:
      • Lodz, Polen, 90-302
        • Rekruttering
        • Santa SP. z o.o
        • Ta kontakt med:
      • Lublin, Polen, 20-081
        • Rekruttering
        • Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
        • Ta kontakt med:
      • Mysłowice, Polen, 41-400
      • Warsaw, Polen, 00-215
        • Rekruttering
        • FutureMeds Warszawa Centrum
        • Ta kontakt med:
      • Warsaw, Polen, 03-712
        • Rekruttering
        • Bodyclinic sp. z o.o. sp.k.
        • Ta kontakt med:
      • Wroclaw, Polen, 53-673
        • Rekruttering
        • FutureMeds Wroclaw
        • Ta kontakt med:
      • Wroclaw, Polen, 54-144
        • Rekruttering
        • EMC Instytut Medyczny S.A. - Wroclaw
        • Ta kontakt med:
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Rekruttering
        • FDI Clinical Research
        • Ta kontakt med:
      • San Juan, Puerto Rico, 00909
        • Rekruttering
        • Latin Clinical Trial Center
        • Ta kontakt med:
      • San Juan, Puerto Rico, 00909
        • Rekruttering
        • Klinical Investigations Group, LLC
        • Ta kontakt med:
  • Romania
      • Bucharest, Romania, 011658
        • Har ikke rekruttert ennå
        • Arensia Clinics S.R.L.
        • Ta kontakt med:
      • Cluj-Napoca, Romania, 400006
        • Rekruttering
        • Cluj Napoca Clinical County Hospital
        • Ta kontakt med:
      • Cluj-Napoca, Romania, 400162
        • Rekruttering
        • Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor"
        • Ta kontakt med:
      • Craiova, Romania, 200642
        • Rekruttering
        • Spitalul Clinic Judetean De Urgenta Craiova
        • Ta kontakt med:
      • Iași, Romania, 700506
      • Satu Mare, Romania, 440055
        • Rekruttering
        • Spital Judetean De Urgenta Satu Mare
        • Ta kontakt med:
  • Saudi-Arabia
      • Riyadh, Saudi-Arabia, 11564
        • Rekruttering
        • King Faisal Specialist Hospital and Research Center
        • Ta kontakt med:
      • Riyadh, Saudi-Arabia, 14611
        • Rekruttering
        • King Abdulaziz Medical City, National Guard Health Affairs
        • Ta kontakt med:
  • Singapore
      • Singapore, Singapore, 169608
        • Rekruttering
        • Singapore General Hospital
        • Ta kontakt med:
      • Singapore, Singapore, 119074
        • Rekruttering
        • National University Hospital
        • Ta kontakt med:
      • Singapore, Singapore, 529889
  • Spania
      • A Coruña, Spania, 15006
        • Rekruttering
        • Complejo Hospitalario Universitario A Coruña
        • Ta kontakt med:
      • Barcelona, Spania, 08035
        • Rekruttering
        • Hospital Universitari Vall d'Hebron
        • Ta kontakt med:
      • Córdoba, Spania, 14004
        • Rekruttering
        • Hospital Universitario Reina Sofía
        • Ta kontakt med:
      • Madrid, Spania, 28041
        • Rekruttering
        • Hospital Universitario 12 de Octubre
        • Ta kontakt med:
      • Majadahonda, Spania, 28222
        • Rekruttering
        • Hospital Puerta de Hierro
        • Ta kontakt med:
      • Pontevedra, Spania, 36071
        • Rekruttering
        • Complexo Hospitalario Universitario de Pontevedra
        • Ta kontakt med:
      • Santander, Spania, 39008
        • Rekruttering
        • Hospital Universitario Marqués de Valdecilla
        • Ta kontakt med:
      • Santiago de Compostela, Spania, 15706
        • Rekruttering
        • Hospital Clínico de Santiago
        • Ta kontakt med:
  • Storbritannia
      • Aberdeen, Storbritannia, AB25 2ZN
      • Ashton in Makerfield, Storbritannia, WN4 8LB
      • Bristol, Storbritannia, BS82RA
      • Camberley, Storbritannia, GU16 7UJ
      • Dagenham, Storbritannia, RM9 5QP
      • Edgbaston, Birmingham, Storbritannia, B15 2WB
      • Edgware, Storbritannia, HA8 0AD
        • Rekruttering
        • Elpida Clinical Trials - Edgware Community Hospital
        • Ta kontakt med:
      • Enfield, London, Storbritannia, EN3 4GS
      • Exeter, Storbritannia, EX2 5AX
        • Rekruttering
        • Royal Devon and Exeter Hospital, Wonford
        • Ta kontakt med:
      • Glasgow, Storbritannia, G51 4TY
      • Hull, Storbritannia, HU3 2JZ
      • London, Storbritannia, SE5 9RS
      • London, Storbritannia, SW10 9NH
      • London, Storbritannia, NW3 2Qg
      • Newcastle upon Tyne, Storbritannia, NE4 6BE
      • Northwood, Storbritannia, HA6 2RN
      • Nottingham, Storbritannia, NG7 2UH
      • Orpington, London, Storbritannia, BR5 3QG
      • Preston, Storbritannia, PR2 9RB
      • Rochdale, Storbritannia, OL11 4AU
      • Sheffield, Storbritannia, S2 5FX
      • Southampton, Storbritannia, SO16 6YD
      • Tooting, London, Storbritannia, SW17 0QT
      • York, Storbritannia, YO24 4LJ
  • Sveits
      • Arzo, Sveits, 6900
        • Rekruttering
        • Fondazione Epatocentro Ticino
        • Ta kontakt med:
      • Bern, Sveits, 3010
        • Rekruttering
        • University Hospital Bern
        • Ta kontakt med:
      • Geneva, Sveits, 1205
        • Rekruttering
        • Hopitaux Universitaires de Geneve (HUG)
        • Ta kontakt med:
      • Zurich, Sveits, 8091
        • Rekruttering
        • University Hospital Zurich
        • Ta kontakt med:
  • Sør -Korea
      • Bucheon-si, Sør -Korea, 14584
        • Rekruttering
        • Soon Chun Hyang University Hospital Bucheon
        • Ta kontakt med:
      • Busan, Sør -Korea, 49241
        • Rekruttering
        • Pusan National University Hospital
        • Ta kontakt med:
      • Deagu, Sør -Korea, 42415
        • Rekruttering
        • Yeungnam University Medical Center
        • Ta kontakt med:
      • Incheon, Sør -Korea, 22332
        • Rekruttering
        • Inha University Hospital
        • Ta kontakt med:
      • Seoul, Sør -Korea, 05505
        • Rekruttering
        • Asan Medical Center
        • Ta kontakt med:
      • Seoul, Sør -Korea, 03080
        • Rekruttering
        • Seoul National University Hospital
        • Ta kontakt med:
      • Seoul, Sør -Korea, 07061
        • Rekruttering
        • SMG-SNU Boramae Medical Center
        • Ta kontakt med:
      • Seoul, Sør -Korea, 6351
        • Rekruttering
        • Samsung Medical Center
        • Ta kontakt med:
      • Seoul, Sør -Korea, 08308
        • Rekruttering
        • Korea University Guro Hospital
        • Ta kontakt med:
      • Seoul, Sør -Korea, 6973
        • Rekruttering
        • Chung-Ang University Hospital
        • Ta kontakt med:
      • Wŏnju, Sør -Korea, 26426
        • Rekruttering
        • Yonsei University Wonju Severance Christian Hospital
        • Ta kontakt med:
  • Sør-Afrika
      • Johannesburg, Sør-Afrika, 2000
        • Har ikke rekruttert ennå
        • Charlotte Maxeke Johannesburg Academic Hospital
        • Ta kontakt med:
      • Johannesburg, Sør-Afrika, 1827
      • Plumstead, Sør-Afrika, 7800
  • Taiwan
      • Changhua, Taiwan, 50006
        • Rekruttering
        • Changhua Christian Hospital
        • Ta kontakt med:
      • Kaohsiung City, Taiwan, 824005
        • Rekruttering
        • E-Da Hospital
        • Ta kontakt med:
      • Kaohsuing City, Taiwan, 80756
        • Rekruttering
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Ta kontakt med:
      • Taichung, Taiwan, 40705
        • Rekruttering
        • Taichung Veterans General Hospital
        • Ta kontakt med:
      • Taichung, Taiwan, 40201
        • Rekruttering
        • Chung Shan Medical University Hospital
        • Ta kontakt med:
      • Tainan, Taiwan, 70403
        • Rekruttering
        • National Cheng Kung University Hospital
        • Ta kontakt med:
      • Tainan, Taiwan, 71004
        • Rekruttering
        • Chi Mei Medical Center
        • Ta kontakt med:
      • Taipei, Taiwan, 110301
        • Rekruttering
        • Taipei Medical University Hospital
        • Ta kontakt med:
      • Taipei, Taiwan, 10048
        • Rekruttering
        • National Taiwan University Hospital
        • Ta kontakt med:
      • Taipei, Taiwan, 112201
        • Rekruttering
        • Taipei Veterans General Hospital
        • Ta kontakt med:
      • Taoyuan, Taiwan, 33305
        • Rekruttering
        • Chang Gung Medical Foundation (CGMF) - Linkou Bran
        • Ta kontakt med:
  • Tsjekkia
      • Liberec, Tsjekkia, 460 01
        • Rekruttering
        • Krajska nemocnice Liberec a.s.
        • Ta kontakt med:
      • Pilsen, Tsjekkia, 301 00
        • Rekruttering
        • Research Site s.r.o.
        • Ta kontakt med:
      • Prague, Tsjekkia, 128 00
        • Rekruttering
        • Vseobecna Fakultni Nemocnice V Praze
        • Ta kontakt med:
  • Tyrkia (Türkiye)
      • Ankara, Tyrkia (Türkiye), 06230
        • Rekruttering
        • Ankara Üniversitesi Tıp Fakültesi Hastanesi
        • Ta kontakt med:
      • Ankara, Tyrkia (Türkiye), 06560
        • Rekruttering
        • Gazi Universitesi Tip Fakultesi
        • Ta kontakt med:
      • Bursa, Tyrkia (Türkiye), 16059
        • Rekruttering
        • Uludag Universitesi Tip Fakultesi
        • Ta kontakt med:
      • Fatih, Tyrkia (Türkiye), 34093
        • Rekruttering
        • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
        • Ta kontakt med:
      • Istanbul, Tyrkia (Türkiye), 34180
        • Rekruttering
        • Memorial Bahçelievler Hospital
        • Ta kontakt med:
      • Istanbul, Tyrkia (Türkiye), 34010
        • Rekruttering
        • Koc Universitesi Hastanesi
        • Ta kontakt med:
      • Izmir, Tyrkia (Türkiye), 35030
        • Rekruttering
        • Ege Universitesi Tip Fakultesi
        • Ta kontakt med:
      • Rize, Tyrkia (Türkiye), 53020
        • Rekruttering
        • Recep Tayyip Erdogan Universitesi Egitim ve Arastirma Hastanesi
        • Ta kontakt med:
  • Tyskland
      • Berlin, Tyskland, 13353
        • Rekruttering
        • Charité - Universitätsmedizin Berlin
        • Ta kontakt med:
      • Bochum, Tyskland, 44892
        • Rekruttering
        • Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
        • Ta kontakt med:
      • Cologne, Tyskland, 50937
        • Rekruttering
        • Universitätsklinikum Köln (AöR)
        • Ta kontakt med:
      • Dresden, Tyskland, 01307
      • Erlangen, Tyskland, 91054
      • Frankfurt, Tyskland, 69590
      • Heidelberg, Tyskland, 69120
        • Rekruttering
        • Universitätsklinikum Heidelberg
        • Ta kontakt med:
      • Homburg, Tyskland, 66421
      • Landshut, Tyskland, 84034
        • Rekruttering
        • Klinikum Landshut AdöR der Stadt Landshut
        • Ta kontakt med:
      • Leipzig, Tyskland, 04103
      • Lübeck, Tyskland, 23538
        • Rekruttering
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
        • Ta kontakt med:
      • Magdeburg, Tyskland, 39120
        • Rekruttering
        • Otto-von-Guericke-Universität Magdeburg
        • Ta kontakt med:
      • Mainz, Tyskland, 55131
        • Rekruttering
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Ta kontakt med:
      • Mannheim, Tyskland, 68167
        • Rekruttering
        • Universitätsklinikum Heidelberg
        • Ta kontakt med:
      • Münster, Tyskland, 49129
      • Tübingen, Tyskland, 72076
      • Wiesbaden, Tyskland, 65189
      • Würzburg, Tyskland, 97080
        • Rekruttering
        • Universitätsklinikum Würzburg AÖR
        • Ta kontakt med:
  • Ungarn
      • Budapest, Ungarn, 1097
        • Rekruttering
        • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
        • Ta kontakt med:
      • Budapest, Ungarn, 1036
      • Budapest, Ungarn, 1082
        • Rekruttering
        • Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika
        • Ta kontakt med:
      • Békéscsaba, Ungarn, 5600
  • Østerrike
      • Graz, Østerrike, 8036
      • Linz, Østerrike, 4010
      • Vienna, Østerrike, 1090
      • Vienna, Østerrike, 1130
      • Vienna, Østerrike, 1030
      • Wels, Østerrike, 4600
        • Rekruttering
        • Klinikum Wels - Grieskirchen GmbH
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Kombinasjonsprodukt: Placebo

Subcutaneous injection, prefilled syringe
Eksperimentell: Survodutide
Kombinasjonsprodukt: Survodutide

Subcutaneous injection, prefilled syringe

Andre navn:
  • BI 456906

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Del 1: Oppløsning av MASH uten forverring av leverfibrose på MASH Clinical Research Network (CRN) fibrosepoeng
Tidsramme: Baseline og ved uke 52.
Baseline og ved uke 52.
Del 1: Minst en 1-punkts forbedring i fibrosestadiet uten forverring av MASH
Tidsramme: Baseline og ved uke 52.
Baseline og ved uke 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Nøkkel sekundært endepunkt del 1: Absolutt endring fra baseline i forbedret leverfibrose (ELF) score
Tidsramme: Baseline og ved uke 52.
Baseline og ved uke 52.
Nøkkel sekundært endepunkt del 1: Oppnåelse av ingen progresjon av fibrose vurdert ved sentral patologi (ja/nei)
Tidsramme: Baseline og ved uke 52.
Baseline og ved uke 52.
Nøkkel sekundært endepunkt del 2: Absolutt endring fra baseline i ELF-score
Tidsramme: Ved baseline og ved uke 114.
Ved baseline og ved uke 114.
Nøkkel sekundært endepunkt del 2: Oppnåelse av ingen progresjon av fibrose vurdert av sentral patologi (ja/nei)
Tidsramme: Ved baseline og ved 7 år.
Ved baseline og ved 7 år.
Viktig sekundært endepunkt del 2: Forekomst av sykehusinnleggelse av alle årsaker (første og tilbakevendende)
Tidsramme: Inntil 7 år.
Inntil 7 år.
Nøkkel sekundært endepunkt del 2: Tid til første forekomst av noen av de bedømte komponentene i det sammensatte endepunktet 5-punkts alvorlig uønsket hjertehendelse (5P-MACE) 5-punkts større uønsket hjertehendelse (5P-MACE)
Tidsramme: Inntil 7 år.
Inntil 7 år.
Del 1: Absolutt endring fra baseline i alaninaminotransferase (ALT) [U/L]
Tidsramme: Ved baseline og ved uke 52.
Ved baseline og ved uke 52.
Del 2: Absolutt endring fra baseline i alaninaminotransferase (ALT) [U/L]
Tidsramme: Ved baseline og ved uke 114.
Ved baseline og ved uke 114.
Del 1: Absolutt endring fra baseline i aspartataminotransferase (AST) [U/L]
Tidsramme: Ved baseline og ved uke 52.
Ved baseline og ved uke 52.
Del 2: Absolutt endring fra baseline i aspartataminotransferase (AST) [U/L]
Tidsramme: Ved baseline og ved uke 114.
Ved baseline og ved uke 114.
Del 1: Absolutt endring fra baseline i systolisk blodtrykk (SBP) [mmHg]
Tidsramme: Ved baseline og ved uke 52.
Ved baseline og ved uke 52.
Del 2: Absolutt endring fra baseline i systolisk blodtrykk (SBP) [mmHg]
Tidsramme: Ved baseline og ved uke 114.
Ved baseline og ved uke 114.
Del 1: Absolutt endring fra baseline i diastolisk blodtrykk (DBP) [mmHg]
Tidsramme: Ved baseline og ved uke 52.
Ved baseline og ved uke 52.
Del 2: Absolutt endring fra baseline i diastolisk blodtrykk (DBP) [mmHg]
Tidsramme: Ved baseline og ved uke 114.
Ved baseline og ved uke 114.
Del 1: Absolutt endring fra baseline i frie fettsyrer [mg/dL]
Tidsramme: Ved baseline og ved uke 52.
Ved baseline og ved uke 52.
Del 2: Absolutt endring fra baseline i frie fettsyrer [mg/dL]
Tidsramme: Ved baseline og ved uke 114.
Ved baseline og ved uke 114.
Del 1: Progresjon til cirrhose (definert som histologisk fibrose-score CRN F4) (ja/nei)
Tidsramme: Ved baseline og ved uke 52.
Ved baseline og ved uke 52.
Nøkkel sekundær endepunkt del 1: Prosentandel fra baseline i kroppsvekt [kg]
Tidsramme: Baseline og i uke 52.
Baseline og i uke 52.
Key Secondary Endpoint Del 1: Absolutt endring fra baseline i leverstivhet [KPA] vurdert med vibrasjonskontrollert forbigående elastografi (VCTE)
Tidsramme: Baseline og i uke 52.
Baseline og i uke 52.
Nøkkel sekundær endepunkt del 2: Prosentandel fra baseline i kroppsvekt [kg]
Tidsramme: Ved baseline og i uke 114
Ved baseline og i uke 114
Key Secondary Endpoint Del 2: Absolutt endring fra baseline i leverstivhet [KPA] vurdert av VCTE
Tidsramme: Ved baseline og i uke 114.
Ved baseline og i uke 114.
Del 2: Absolutte endringer fra baseline i lipider [mg/dl] (inkludert, men ikke begrenset til: total kolesterol, LDL-kolesterol, veldig lav tetthet lipoprotein [VLDL] kolesterol, lipoprotein med høy tetthet [HDL] kolesterol, triglyser))
Tidsramme: Ved baseline og i uke 114.
Ved baseline og i uke 114.
Key secondary endpoint part 1: Absolute change from baseline in glycosylated haemoglobin (HbA1c) [%]
Tidsramme: 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 2: Absolute change from baseline in HbA1c [%]
Tidsramme: 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
Part 1: Improvement of liver fat content (LFC)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: At baseline and at Week 52.

LDL=low-density lipoprotein
At baseline and at Week 52.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. oktober 2024

Primær fullføring (Antatt)

27. desember 2031

Studiet fullført (Antatt)

27. desember 2031

Datoer for studieregistrering

Først innsendt

8. oktober 2024

Først innsendt som oppfylte QC-kriteriene

8. oktober 2024

Først lagt ut (Faktiske)

9. oktober 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere