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)

Randomised, open-label and parallel group trial to investigate the effects of oral BI 685509 alone or in combination with empagliflozin on portal hypertension after 8 weeks treatment in patients with clinically significant portal hypertension (CSPH) incompensated cirrhosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220376

Enrollment

Registered

2022-10-14

Start date

2022-10-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with CSPH in compensated cirrhosis due to HBV, HCV, and NASH with or without T2DM

Interventions

Treatment group 1, 2, 3: 685509 (maintenance dose) Treatment group 4: BI 685509 (maintenance dose) + Empagliflozin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female who is >= 18 (or who is of legal age in countries where that is greater than 18) and = 10 mmHg (measured at Visit 1c), based on a local interpretation of the pressure tracing Diagnosis of compensated cirrhosis due to HBV, HCV or NASH with or without 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 x103/micro L], nodular liver surface on imaging or splenomegaly etc.) Willing and able to undergo HVPG measurements per protocol (based on Investigator judgement) If receiving statins, NSBBs or carvedilol 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 pioglitazone, GLP1-agonists, or vitamin E must be on a stable dose for at least 3 months prior to screening (Visit1b), with no planned dose change throughout the trial

Exclusion criteria

Exclusion criteria: Previous clinically significant decompensation events (e.g. ascites [more than perihepatic ascites], VH and / or apparent HE) History of other forms of chronic liver disease (e.g. alcoholrelated liver disease, autoimmune liver disease, primary biliary sclerosis, primary sclerosing cholangitis, Wilsons disease, haemachromatosis, alpha-1 antitrypsin [A1At] deficiency) Patients without adequate treatment for HBV, HCV, or NASH (e.g. antiviral therapy in chronic HBV or HCV or lifestyle modification in NASH) SBP = B8 at screening (Visit 1a) ALT or AST > 5 times upper limit of normal (ULN) at screening (Visit 1a) eGFR (CKD-EPI formula) 50 ng/mL (> 50 micro g/L) at screening (Visit 1a) History of clinically relevant orthostatic hypotension, faintingspells or blackouts due to hypotension or of unknown origin (based on Investigator judgement) Current or planned SGLT2i / SGLT-1/2i treatment Type 1 Diabetes Mellitus

Design outcomes

Primary

Measure	Time frame
Percentage change in HVPG from baseline (measured in mmHg) after 8 weeks of treatment.	—

Secondary

Measure	Time frame
Occurrence of a response, which is defined as > 10% reduction from baseline HVPG (measured in mmHg) after 8 weeks of treatment 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 Occurrence of CTCAE grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the 8 week treatment period Occurrence of discontinuation due to hypotension or syncope during the 8 week treatment period	—

Measure

Time frame

Occurrence of a response, which is defined as > 10% reduction from baseline HVPG (measured in mmHg) after 8 weeks of treatment 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 Occurrence of CTCAE grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the 8 week treatment period Occurrence of discontinuation due to hypotension or syncope during the 8 week treatment period

—

Countries

Argentina, Austria, Belgium, Canada, China, Denmark, France, Germany, Israel, Itay, Japan, Netherlands, Republic of Korea, Singapore, Spain, Switzerland, United Kingdom, United States

Contacts

Public ContactNobuko Yamada

Boehringer Ingelheim

medchiken.jp@boehringer-ingelheim.com+81-120189779

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026