A Study to Test Whether BI 685509 Alone or in Combination With Empagliflozin Helps People With Liver Cirrhosis Caused by Viral Hepatitis or Non-alcoholic Steatohepatitis (NASH) Who Have High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)
NCT ID: NCT05282121
Last Updated: 2025-09-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
90 participants
INTERVENTIONAL
2022-06-28
2024-06-07
Brief Summary
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The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) taken alone or in combination with a medicine called empagliflozin helps people with this condition.
Participants take Avenciguat (BI 685509) as tablets twice a day for 8 weeks. Half of the participants with NASH who also have type 2 diabetes take empagliflozin as tablets once a day in addition to Avenciguat (BI 685509).
Participants are in the study for about 3 months. During this time, they visit the study site about 10 times. At 2 of the visits, the doctors check the pressure in a liver vein to see whether the treatment works. This is done with a catheter (a long thin tube) and gives information about the pressure in the portal vein. The doctors also regularly check participants' health and take note of any unwanted effects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients with HBV - avenciguat
Patients with Hepatitis B Virus (HBV) were administered one film-coated tablet of avenciguat orally twice a day. The two doses were ideally taken at least 10 hours apart. The starting dose was 1 milligram (mg), which, if tolerated, was up-titrated to 2 mg one week later. If this dose was also tolerated, a second up-titration to 3 mg occured after another week. Patients remained on the highest dose for the remainder of the treatment period, until 8 weeks of treatment.
Avenciguat
one film-coated tablet orally twice a day, at least 10 hours apart. The starting dose (1 mg) was up-titrated up to 3 mg
Patients with HCV - avenciguat
Patients with Hepatitis C Virus (HCV) were administered one film-coated tablet of avenciguat orally twice a day. The two doses were ideally taken at least 10 hours apart. The starting dose was 1 milligram (mg), which, if tolerated, was up-titrated to 2 mg one week later. If this dose was also tolerated, a second up-titration to 3 mg occured after another week. Patients remained on the highest dose for the remainder of the treatment period, until 8 weeks of treatment.
Avenciguat
one film-coated tablet orally twice a day, at least 10 hours apart. The starting dose (1 mg) was up-titrated up to 3 mg
Patients with NASH with or without T2DM - avenciguat
Patients with Non-Alcoholic Steatohepatitis (NASH) with or without type 2 Diabetes Mellitus (T2DM) were administered one film-coated tablet of avenciguat orally twice a day. The two doses were ideally taken at least 10 hours apart. The starting dose was 1 milligram (mg), which, if tolerated, was up-titrated to 2 mg one week later. If this dose was also tolerated, a second up-titration to 3 mg occured after another week. Patients remained on the highest dose for the remainder of the treatment period, until 8 weeks of treatment.
Avenciguat
one film-coated tablet orally twice a day, at least 10 hours apart. The starting dose (1 mg) was up-titrated up to 3 mg
Patients with NASH with T2DM - avenciguat + empagliflozin
Patients with Non-Alcoholic Steatohepatitis (NASH) with type 2 Diabetes Mellitus (T2DM) were administered one film-coated tablet of avenciguat orally twice a day. The two doses were ideally taken at least 10 hours apart. The starting dose was 1 milligram (mg), which, if tolerated, was up-titrated to 2 mg one week later. If this dose was also tolerated, a second up-titration to 3 mg occured after another week. Patients remained on the highest dose for the remainder of the treatment period, until 8 weeks of treatment.
Patients were additionally administered one 10 mg film-coated tablet of empagliflozin orally once a day.
Avenciguat
one film-coated tablet orally twice a day, at least 10 hours apart. The starting dose (1 mg) was up-titrated up to 3 mg
Empagliflozin
one 10 mg film-coated tablet of orally once a day
Interventions
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Avenciguat
one film-coated tablet orally twice a day, at least 10 hours apart. The starting dose (1 mg) was up-titrated up to 3 mg
Empagliflozin
one 10 mg film-coated tablet of orally once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female who is ≥ 18 (or who is of legal age in countries where that is greater than 18) and ≤ 75 years old at screening (Visit 1a)
* Clinical signs of Clinically Significant Portal Hypertension (CSPH) as described by either one of the points below. Each trial patient must have a gastroscopy during the screening period (Visit 1b) or within 6 months prior to screening (Visit 1b).
* documented endoscopic proof of oesophageal varices and / or gastric varices at screening (Visit 1b) or within 6 months prior to screening (Visit 1b)
* documented endoscopic-treated oesophageal varices as preventative treatment
* CSPH defined as baseline Hepatic Venous Pressure Gradient (HVPG) ≥ 10 mmHg (measured at Visit 1c), based on a local interpretation of the pressure tracing
* Diagnosis of compensated cirrhosis due to Hepatitis C virus (HCV), Hepatitis B virus (HBV), or Non-Alcoholic Steatohepatitis (NASH) with or without Type 2 Diabetes Melitus (T2DM). Diagnosis of cirrhosis must be based on histology (historical data is acceptable) or on clinical evidence of cirrhosis (e.g. platelet count \< 150 x 109/L \[150 x 103/microlitre (μL)\], nodular liver surface on imaging or splenomegaly etc.) Diagnosis of NASH based on either i. Current or historic histological diagnosis of NASH OR steatosis OR ii. Clinical diagnosis of NASH based on historic or current imaging diagnosis of fatty liver (Fibroscan, Ultrasound (US), Magnetic Resonance Imaging (MRI), Computed Tomography (CT)) AND at least 2 current or historic comorbidities of the metabolic syndrome (overweight/obesity, T2DM, hypertension, hyperlipidemia)
* Willing and able to undergo HVPG measurements per protocol (based on Investigator judgement)
* If receiving statins must be on a stable dose for at least 3 months prior to screening (Visit 1b), with no planned dose change throughout the trial
* If receiving treatment with Non-Selective Beta-Blocker (NSBBs) or carvedilol must be on a stable dose for at least 1 months prior to screening (Visit 1b), with no planned dose change throughout the trial
Exclusion Criteria
* History of other forms of chronic liver disease (e.g. alcohol-related liver disease (ARLD), autoimmune liver disease, primary biliary sclerosis, primary sclerosing cholangitis, Wilson's disease, haemachromatosis, alpha-1 antitrypsin \[A1At\] deficiency)
* Patients without adequate treatment for HBV, HCV or NASH as per local guidance (e.g. antiviral therapy for chronic HBV or HCV infection or lifestyle modification in NASH)
* if received curative anti-viral therapy for HCV, no sustained virological response (SVR) or SVR sustained for less than 2 years prior to screening or if HCV Ribonucleic Acid (RNA) detectable
* If receiving anti-viral therapy for HBV, less than 6 months on a stable dose prior to screening, with planned dose change during the trial or HBV deoxyribonucleic acid (DNA) detectable
* Weight change ≥ 5% within 6 months prior screening
* Must take, or wishes to continue the intake of, restricted concomitant therapy or any concomitant therapy considered likely (based on Investigator judgement) to interfere with the safe conduct of the trial
* Systolic Blood Pressure (SBP) \< 100 mmHg and Diastolic Blood Pressure (DBP) \< 70 mmHg at screening (Visit 1a)
* Model of End-stage Liver Disease (MELD) score of \> 15 at screening (Visit 1a), calculated by the central laboratory
* Hepatic impairment defined as a Child-Turcotte-Pugh score ≥ B8 at screening (Visit 1a), calculated by the site, using central laboratory results
* Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \> 5 times upper limit of normal (ULN) at screening (Visit 1a), measured by the central laboratory
18 Years
75 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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California Liver Research Institute
Pasadena, California, United States
Inland Empire Clinical Trials, LLC
Rialto, California, United States
Floridian Clinical Research-Miami Lakes-68368
Miami Lakes, Florida, United States
American Research Corporation
San Antonio, Texas, United States
Hospital Britanico de Buenos Aires
CABA, , Argentina
Hospital Italiano de Buenos Aires
CABA, , Argentina
AKH - Medical University of Vienna
Vienna, , Austria
Edegem - UNIV UZ Antwerpen
Edegem, , Belgium
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Beijing Friendship Hospital
Beijing, , China
NanFang Hosptial
Guangzhou, , China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, , China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, , China
Hvidovre Hospital
Hvidovre, , Denmark
HOP Beaujon
Clichy, , France
HOP Rangueil
Toulouse, , France
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Universitätsklinikum Münster
Münster, , Germany
Rambam Medical Center
Haifa, , Israel
Western Galilee Hospital
Nahariya, , Israel
Ospedale Civile di Baggiovara
Baggiovara (MO), , Italy
Azienda Ospedaliera Policlinico di Modena
Modena, , Italy
Policlinico "Paolo Giaccone"
Palermo, , Italy
National Hospital Organization Yokohama Medical Center
Kanagawa, Yokohama, , Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, , Japan
Amsterdam UMC, location VUMC
Amsterdam, , Netherlands
Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor"
Cluj-Napoca, , Romania
Singapore General Hospital
Singapore, , Singapore
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Countries
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References
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Reiberger T, Berzigotti A, Trebicka J, Ertle J, Gashaw I, Swallow R, Tomisser A. The rationale and study design of two phase II trials examining the effects of BI 685,509, a soluble guanylyl cyclase activator, on clinically significant portal hypertension in patients with compensated cirrhosis. Trials. 2023 Apr 24;24(1):293. doi: 10.1186/s13063-023-07291-3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2021-005171-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-504257-12-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
1366-0029
Identifier Type: -
Identifier Source: org_study_id
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