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Study on the Effects of BI 685509 for Patients with Liver Cirrhosis and Portal Hypertension After First Decompensation Event

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called clinically significant portal hypertension in patients with decompensated cirrhosis. This condition often occurs in people with liver cirrhosis, which is a severe liver disease. The trial is investigating a new treatment called BI 685509, which is taken as a film-coated tablet. The purpose of the study is to see if this treatment can help reduce high blood pressure in the portal vein, which is the main blood vessel going to the liver, after 8 weeks of treatment.

Participants in the study will receive either the BI 685509 tablet or a placebo, which looks like the real medication but does not contain the active substance. The study will last for 8 weeks, during which the effects of the treatment on the portal hypertension will be closely monitored. The trial aims to determine the safety and tolerability of BI 685509 in patients who have experienced a first decompensation event, such as bleeding in the esophagus or fluid accumulation in the belly, and are now stabilized.

Throughout the study, participants will be required to take the medication orally, and their health will be regularly checked to ensure their safety. The main goal is to measure any changes in the pressure within the portal vein and to observe if the treatment can effectively manage the condition compared to the placebo. This research is important for finding new ways to help people with liver cirrhosis and related complications.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Eligibility criteria include age between 18 and 75, a diagnosis of cirrhosis due to non-cholestatic liver disease, and a history of a significant decompensation event.

  2. Step 2

    Randomization and baseline measurements

    Participants are randomly assigned to receive either the BI 685509 medication or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

    Baseline measurements, including hepatic venous pressure gradient (HVPG), are taken to assess the starting point for each participant.

  3. Step 3

    Treatment phase

    Participants begin an 8-week treatment period. The medication, BI 685509, is administered orally in the form of a film-coated tablet.

    The dosage is adjusted to a fixed regimen through a process called up-titration, which involves gradually increasing the dose to reach the desired level.

  4. Step 4

    Monitoring and follow-up

    Throughout the treatment period, participants are monitored for any changes in health status, including the occurrence of further decompensation events or side effects such as hypotension or syncope.

    Regular follow-up visits are scheduled to track progress and ensure safety.

  5. Step 5

    Final assessment

    At the end of the 8-week treatment period, a final assessment is conducted. This includes measuring the percentage change in HVPG from baseline to evaluate the effectiveness of the treatment.

    The occurrence of any significant health events during the trial is also reviewed.

Who can join the trial?

10 criteria

  • Provide a signed and dated written informed consent before joining the trial. This means you agree to participate after understanding the details of the study.
  • If you are a man who can father a child and have a female partner who can become pregnant, you must use a condom or practice complete sexual abstinence, or have had a vasectomy. This is required from the start of the trial until 7 days after the last treatment.
  • You must be between 18 and 75 years old at the time of screening.
  • You need to have a diagnosis of cirrhosis, which is a type of liver disease, not caused by bile duct problems. This includes conditions like hepatitis C, hepatitis B, non-alcoholic fatty liver disease, alcohol-related liver disease, autoimmune hepatitis, Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency.
  • You must have had one previous significant liver-related health issue that was resolved at least 4 weeks before the screening. This could be a first bleeding from varices (enlarged veins) or a first episode of significant fluid buildup in the abdomen that needed treatment.
  • You should be willing and able to undergo HVPG measurements, which are tests to measure pressure in the liver, as per the study's requirements.
  • If you are taking statins, which are medications to lower cholesterol, you must have been on a stable dose for at least 3 months before screening, with no plans to change the dose during the trial.
  • If you are taking NSBBs (non-selective beta-blockers) or carvedilol, which are medications for heart and liver conditions, you must have been on a stable dose for at least 1 month before screening, with no plans to change the dose during the trial.
  • If your cirrhosis is related to alcohol, you must not have misused or abused alcohol for at least 2 months before screening and must be able to avoid alcohol throughout the trial.
  • If you are a woman who can become pregnant, you must use highly effective birth control methods that have a low failure rate when used correctly, from the start of the trial until 7 days after the last treatment. You must also agree to regular pregnancy testing during the trial.

Who cannot join the trial?

6 criteria

  • Patients with other types of liver disease that are not related to non-cholestatic liver disease.
  • Patients who have not been diagnosed with clinically significant portal hypertension (CSPH). This is a condition where there is high blood pressure in the veins that carry blood to the liver.
  • Patients who do not have decompensated cirrhosis. This is a stage of liver disease where the liver is severely damaged and cannot function properly.
  • Patients who are not receiving the standard care for their liver condition.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population that requires special protection.
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Investigated drugs

BI 685509 is an experimental medication being studied for its potential effects on portal hypertension in patients with decompensated cirrhosis. The trial aims to assess the safety and tolerability of this medication when added to the standard care for patients with clinically significant portal hypertension. The primary goal is to determine how much the medication can change the pressure in the portal vein after 8 weeks of treatment.

What is already known about the treatment

BI 685509 – This medication is administered orally and is currently being studied in clinical trials. It is being investigated for its potential to treat clinically significant portal hypertension in patients with decompensated cirrhosis due to non-cholestatic liver disease. The main therapeutic indication is to reduce portal hypertension, which is a common complication in liver cirrhosis. At the molecular level, BI 685509 works by targeting specific pathways that influence blood flow and pressure in the liver. It is classified pharmacologically as a treatment for liver-related conditions, specifically focusing on reducing portal hypertension.

Investigated diseases

Clinically Significant Portal Hypertension (CSPH) in Decompensated Cirrhosis due to Non-Cholestatic Liver Disease – This condition occurs when there is increased blood pressure in the portal vein, which carries blood from the digestive organs to the liver. In decompensated cirrhosis, the liver is severely scarred and unable to function properly, leading to complications. CSPH can cause blood to bypass the liver, leading to the development of varices, which are enlarged veins that can bleed. It may also result in fluid accumulation in the abdomen, known as ascites, and can affect brain function, causing hepatic encephalopathy. The progression of CSPH involves worsening liver function and increased risk of complications as the liver becomes more damaged.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506083-13-00Protocol code1366-0055Estimated enrolment42 patientsSponsorBoehringer Ingelheim Espana S.A.

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