80
Participants
Start Date
April 27, 2022
Primary Completion Date
May 2, 2024
Study Completion Date
June 12, 2024
Avenciguat (BI 685509)
Participants received Avenciguat twice daily (BID) throughout the study. Up-titration depended on the assigned dose group. At Visit 2 (Week 1), each dose included one 1 mg Avenciguat tablet. At Visit 3 (Week 2), the dose was increased to one 2 mg Avenciguat tablet per dose. From Visit 4 onward (Week 3+), participants received one 3 mg Avenciguat tablet per dose. This regimen continued for 24 weeks, with all doses taken with water, with or without food.
Placebo matching Avenciguat (BI 685509)
Participants received matching placebo twice daily (BID) throughout the study. At Visit 2 (Week 1), each dose included one 1 mg and one 2 mg placebo tablet (four tablets daily). A pseudo up-titration was applied at Visit 3 (Week 2), maintaining the same tablet composition to preserve blinding. From Visit 4 (Week 3) onward, a second pseudo up-titration adjusted each dose to one 2 mg and one 3 mg placebo tablet (four tablets daily). All doses were taken with water, with or without food.
AKH - Medical University of Vienna, Vienna
Edegem - UNIV UZ Antwerpen, Edegem
Hvidovre Hospital, Hvidovre
Medical University of Innsbruck, Innsbruck
Ospedale Regionale di Lugano, Viganello
University Hospital Dubrava, Zagreb
Northwell Health Center for Liver Disease, Manhasset
Taipei Veterans General Hospital, Taipei
Soon Chun Hyang University Hospital Bucheon, Bucheon-si, Gyeonggi-do
ASST Grande Ospedale Metropolitano Niguarda, Milan
Yonsei University Wonju Severance Christian Hospital, Wonju-si, Gangwon State
Hospital Ramón y Cajal, Madrid
Hospital Puerta de Hierro, Majadahonda
Medical University of South Carolina, Charleston
HOP Rangueil, Toulouse
Floridian Clinical Research-Miami Lakes-68368, Miami Lakes
Azienda Ospedaliera Policlinico di Modena, Modena
Universitätsklinikum Münster, Münster
HOP d'Angers, Angers
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz
St. Josefs-Hospital, Wiesbaden, Wiesbaden
American Research Corporation at the Texas Liver Institute, San Antonio
"Policlinico Paolo Giaccone", Palermo
California Liver Research Institute, Pasadena
Inland Empire Clinical Trials, LLC, Rialto
Beijing Friendship Hospital, Beijing
Beijing Youan Hospital, Capital Medical University, Beijing
Singapore General Hospital, Singapore
The Affiliated Hospital of Hangzhou Normal University, Hangzhou
"Regional Institute of Gastroenterology Hepatology Prof. Dr. O. Fodor", Cluj-Napoca
NanFang Hosptial, Guangzhou
Western Galilee Hospital, Nahariya
Hospital Italiano de Buenos Aires, CABA
Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal
Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma
Shin-yurigaoka General Hospital, Kanagawa, Kawasaki
Kitasato University Hospital, Kanagawa, Sagamihara
Yokohama City University Hospital, Kanagawa, Yokohama
National Hospital Organization Yokohama Medical Center, Kanagawa, Yokohama
Osaka Metropolitan University Hospital, Osaka, Osaka
Leids Universitair Medisch Centrum (LUMC), Leiden
ULS de Santa Maria, E.P.E, Lisbon
Hospital Vall d'Hebron, Barcelona
Queen Elizabeth Hospital Birmingham, Birmingham
St Mary's Hospital, London
Lead Sponsor
Boehringer Ingelheim
INDUSTRY