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)
TerminatedPhase 2Results postedLast updated 4 September 2025
What this trial tests
Phase 2 trial testing Avenciguat in Liver Diseases in 90 participants. Terminated before completion.
Adults 18 to 75, any sex, with Liver Diseases or Hypertension, Portal. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage Change in HVPG From Baseline (Measured in mmHg) After 8 Weeks of TreatmentPrimary· Before the first intake of trial medication (baseline), and after 8 weeks of treatment.
Percentage change in Hepatic Venous Pressure Gradient (HVPG) from baseline (measured in millimetre of mercury \[mmHg\]) after 8 weeks of treatment is reported. Adjusted mean (Least Square Mean) was calculated using an analysis of covariance (ANCOVA) model without imputing the missing data. The model included treatment as fixed classification effects, and baseline HVPG as a linear covariate. The random error was assumed to be normally distributed with mean 0 and variance σ².
Group
Value
95% CI
Patients With HBV - Avenciguat
-16.06
± 6.66
Patients With HCV - Avenciguat
-5.81
± 7.09
Patients With NASH With or Without T2DM - Avenciguat
3.83
± 4.25
Patients With NASH With T2DM - Avenciguat + Empagliflozin
3.27
± 5.08
Occurrence of a Response, Which is Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 8 Weeks of TreatmentSecondary· Before the first intake of trial medication (baseline), and after 8 weeks of treatment.
Occurrence of a response, which is defined as \> 10% reduction from baseline HVPG (measured in mmHg) after 8 weeks of treatment is reported.
Group
Value
95% CI
Patients With HBV - Avenciguat
9
Patients With HCV - Avenciguat
2
Patients With NASH With or Without T2DM - Avenciguat
9
Patients With NASH With T2DM - Avenciguat + Empagliflozin
4
Occurrence of One or More Decompensation Events (i.e. Ascites, VH, and / or Overt HE) During the 8-week Treatment PeriodSecondary· From first intake of study medication, until last intake of study medication plus 7 days, up to approximately 10 weeks.
Occurrence of one or more decompensation events (i.e. ascites, Variceal Haemorrhage \[VH\], and / or overt Hepatic Encephalopathy \[HE\]) during the 8-week treatment period is reported.
Group
Value
95% CI
Patients With HBV - Avenciguat
1
Patients With HCV - Avenciguat
0
Patients With NASH With or Without T2DM - Avenciguat
4
Patients With NASH With T2DM - Avenciguat + Empagliflozin
1
Occurrence of CTCAE Grade 3 (or Higher) Hypotension or Syncope Based on Investigator Judgement, During the 8-week Treatment PeriodSecondary· From first intake of study medication, until last intake of study medication plus 7 days, up to approximately 10 weeks.
Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the 8-week treatment period is reported.
The CTCAE grades are: 1 (mild Adverse Event \[AE\]), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).
Group
Value
95% CI
Patients With HBV - Avenciguat
0
Patients With HCV - Avenciguat
0
Patients With NASH With or Without T2DM - Avenciguat
0
Patients With NASH With T2DM - Avenciguat + Empagliflozin
1
Occurrence of Discontinuation Due to Hypotension or Syncope During the 8-week Treatment PeriodSecondary· From first intake of study medication, until last intake of study medication plus 7 days, up to approximately 10 weeks.
Occurrence of discontinuation of treatment with avenciguat due to hypotension or syncope during the 8-week treatment period is reported.
Group
Value
95% CI
Patients With HBV - Avenciguat
0
Patients With HCV - Avenciguat
0
Patients With NASH With or Without T2DM - Avenciguat
0
Patients With NASH With T2DM - Avenciguat + Empagliflozin
1
Adverse events — posted to ClinicalTrials.gov
Time frame: From first intake of study medication, until last intake of study medication plus 7 days, up to approximately 10 weeks (adverse events), or until end of study, up to 12 weeks (all-cause mortality)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Patients With HBV - Avenciguat
Serious: 1/14 (7%)
Deaths: 0/14
Patients With HCV - Avenciguat
Serious: 2/13 (15%)
Deaths: 0/13
Patients With NASH With or Without T2DM - Avenciguat
Serious: 6/38 (16%)
Deaths: 0/38
Patients With NASH With T2DM - Avenciguat + Empagliflozin
Serious: 0/25 (0%)
Deaths: 0/25
Serious adverse events (8 terms)
Reaction
System
Patients With HBV - Avenci…
Patients With HCV - Avenci…
Patients With NASH With or…
Patients With NASH With T2…
Pancytopenia
Blood and lymphatic system disorders
—
—
—
—
Melaena
Gastrointestinal disorders
—
—
—
—
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
—
—
—
—
Erysipelas
Infections and infestations
—
—
—
—
Herpes zoster
Infections and infestations
—
—
—
—
Hepatic cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This study is open to adults with liver cirrhosis caused by hepatitis B, hepatitis C or nonalcoholic steatohepatitis (NASH). People can join this study if they have high blood pressure in the portal vein (main vessel going to the liver).
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06082843 — A Study to Test Whether Avenciguat Helps People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Ve
· Phase 2
· terminated
NCT04736628 — A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 4 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05282121.