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Experimental pill avenciguat targets liver blood pressure in cirrhosis – but trial halted early

NCT ID NCT05161481

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a drug called Avenciguat in adults with liver cirrhosis and high blood pressure in the portal vein (the main vessel to the liver). Participants took either a low or high dose of Avenciguat or a placebo twice daily for 24 weeks. The goal was to see if the drug could lower this blood pressure. The trial was terminated early, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Avenciguat (BI 685509)
What this could lead to
If it works, this could point toward a new oral treatment to lower dangerous blood pressure in the liver's main vein for people with cirrhosis.
What could go wrong
This was a small, early-phase (phase 2) trial that was terminated, so results are limited. It is not yet proven to be safe or effective, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

80 people

The number who actually took part.

Started

Apr 2022

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial 2. 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 3. 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 or within 6 months prior to screening. * documented endoscopic proof of oesophageal varices and / or gastric varices at screening or within 6 months prior to screening * documented endoscopic-treated oesophageal varices as preventative treatment 4. CSPH defined as baseline Hepatic Venous Pressure Gradient (HVPG) ≥ 10 mmHg, based on a local interpretation of the pressure tracing 5. Diagnosis of compensated alcohol-related cirrhosis. Diagnosis must be based on histology (historical data is acceptable) or on clinical evidence of cirrhosis (e.g. platelet count \< 150 x 10\^9/L \[150 x 10\^3/µL\], nodular liver surface on imaging or splenomegaly) 6. Abstinence from significant alcohol misuse / abuse for a minimum of 2 months prior to screening, and the ability to abstain from alcohol throughout the trial (both evaluated based on Investigator judgement) 7. Willing and able to undergo HVPG measurements per protocol (based on Investigator judgement) 8. If receiving statins must be on a stable dose for at least 3 months prior to screening, with no planned dose change throughout the trial Further inclusion criteria apply. Exclusion Criteria: 1. Previous clinically significant decompensation events (e.g. ascites \[more than perihepatic ascites\], Variceal Haemorrhage (VH) and / or apparent Hepatic Encephalopathy (HE)) 2. History of other forms of chronic liver disease (e.g. non-alcoholic steatohepatitis (NASH), Hepatitis B virus (HBV), untreated Hepatitis C Virus (HCV), autoimmune liver disease, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, haemachromatosis, alpha-1 antitrypsin (A1At) deficiency) 3. Has received curative anti-viral therapy with direct-acting anti-virals within the last 2 years for HCV, or, if such treatment was \> 2 years ago and there is no sustained virological response (SVR) at screening, or, must take curative anti-viral therapy with direct-acting anti-virals throughout the trial 4. Alcohol-Related Liver Disease (ARLD) without adequate treatment (e.g. lifestyle modification) or with ongoing pathological drinking behaviour (misuse / abuse based on Investigator judgement) 5. 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 6. Systolic Blood Pressure (SBP) \< 100 mmHg and Diastolic Blood Pressure (DBP) \< 70 mmHg at screening 7. Model of End-stage Liver Disease (MELD) score of \> 15 at screening, calculated by the central laboratory 8. Hepatic impairment defined as a Child-Turcotte-Pugh score ≥ B8 at screening, calculated by the site, using central laboratory results Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver portal hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension, portal

Contacts and locations

Locations

  • AKH - Medical University of Vienna

    Vienna, 1090, Austria

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • American Research Corporation at the Texas Liver Institute

    San Antonio, Texas, 78215, United States

  • Azienda Ospedaliera Policlinico di Modena

    Modena, 41124, Italy

  • Beijing Friendship Hospital

    Beijing, 100050, China

  • Beijing Youan Hospital, Capital Medical University

    Beijing, 100071, China

  • California Liver Research Institute

    Pasadena, California, 91105, United States

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0A9, Canada

  • Edegem - UNIV UZ Antwerpen

    Edegem, 2650, Belgium

  • Floridian Clinical Research-Miami Lakes-68368

    Miami Lakes, Florida, 33016, United States

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00195, Italy

  • HOP Rangueil

    Toulouse, 31059, France

  • HOP d'Angers

    Angers, 49933, France

  • Hospital Italiano de Buenos Aires

    CABA, C1199ABB, Argentina

  • Hospital Puerta de Hierro

    Majadahonda, 28222, Spain

  • Hospital Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hvidovre Hospital

    Hvidovre, 2650, Denmark

  • Inland Empire Clinical Trials, LLC

    Rialto, California, 92377, United States

  • Kitasato University Hospital

    Kanagawa, Sagamihara, 252-0375, Japan

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZA, Netherlands

  • Medical University of Innsbruck

    Innsbruck, 6020, Austria

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • NanFang Hosptial

    Guangzhou, 510515, China

  • National Hospital Organization Yokohama Medical Center

    Kanagawa, Yokohama, 245-8575, Japan

  • Northwell Health Center for Liver Disease

    Manhasset, New York, 11030, United States

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586, Japan

  • Ospedale Regionale di Lugano

    Viganello, 6962, Switzerland

  • Policlinico "Paolo Giaccone"

    Palermo, 90127, Italy

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2TH, United Kingdom

  • Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor"

    Cluj-Napoca, 400000, Romania

  • Shin-yurigaoka General Hospital

    Kanagawa, Kawasaki, 215-0026, Japan

  • Singapore General Hospital

    Singapore, 169608, Singapore

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, Gyeonggi-do, 14584, South Korea

  • St Mary's Hospital

    London, W2 1NY, United Kingdom

  • St. Josefs-Hospital, Wiesbaden

    Wiesbaden, 65189, Germany

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, 310000, China

  • ULS de Santa Maria, E.P.E

    Lisbon, 1649-035, Portugal

  • University Hospital Dubrava

    Zagreb, 10000, Croatia

  • Universitätsklinikum Münster

    Münster, 48149, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131, Germany

  • Western Galilee Hospital

    Nahariya, 2210001, Israel

  • Yokohama City University Hospital

    Kanagawa, Yokohama, 236-0004, Japan

  • Yonsei University Wonju Severance Christian Hospital

    Wonju-si, Gangwon State, 26426, South Korea

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