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New drug combo aims to lower liver vein pressure in cirrhosis patients

NCT ID NCT05282121

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether the drug Avenciguat, taken alone or with empagliflozin, can lower high blood pressure in the portal vein (the main vessel to the liver) in people with cirrhosis. About 90 adults with cirrhosis from hepatitis or fatty liver disease were enrolled. The trial was terminated early, so the full results are not available.

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) and empagliflozin
What this could lead to
If it works, this could lead to a new treatment option to reduce dangerous pressure in the liver's main vein, potentially preventing complications in cirrhosis.
What could go wrong
This was a small, early-phase trial that was terminated, so results are limited. It is unclear if the drug will prove effective or safe in larger studies.

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

90 people

The number who actually took part.

Started

Jun 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: * Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial * 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 * Further inclusion criteria apply Exclusion Criteria: * Previous clinically significant decompensation events (e.g. ascites \[more than perihepatic ascites\], Variceal Haemorrhage (VH) and / or overt / apparent Hepatic Encephalopathy (HE)) * 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 * Further exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver liver disorder portal hypertension

As listed by the trial registrant

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

Hypertension, portal Liver diseases

Contacts and locations

Locations

  • AKH - Medical University of Vienna

    Vienna, 1090, Austria

  • American Research Corporation

    San Antonio, Texas, 78215, United States

  • Amsterdam UMC, location VUMC

    Amsterdam, 1105 AZ, Netherlands

  • Azienda Ospedaliera Policlinico di Modena

    Modena, 41124, Italy

  • Beijing Friendship Hospital

    Beijing, 100050, 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

  • HOP Beaujon

    Clichy, 92118, France

  • HOP Rangueil

    Toulouse, 31059, France

  • Hospital Britanico de Buenos Aires

    CABA, 1280AEB, Argentina

  • Hospital Italiano de Buenos Aires

    CABA, C1199ABB, Argentina

  • 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

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • NanFang Hosptial

    Guangzhou, 510515, China

  • National Hospital Organization Yokohama Medical Center

    Kanagawa, Yokohama, 245-8575, Japan

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586, Japan

  • Ospedale Civile di Baggiovara

    Baggiovara (MO), 41126, Italy

  • Policlinico "Paolo Giaccone"

    Palermo, 90127, Italy

  • Rambam Medical Center

    Haifa, 31096, Israel

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

    Cluj-Napoca, 400000, Romania

  • Singapore General Hospital

    Singapore, 169608, Singapore

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, 310015, China

  • Universitätsklinikum Münster

    Münster, 48149, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131, Germany

  • Western Galilee Hospital

    Nahariya, 2210001, Israel

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, 200032, China

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