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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)
EU CTIS ID: 2023-504257-12-00
What this study is testing
The trial will investigate the safety and tolerability of BI 685509 in patients with CSPH in compensated cirrhosis due to HBV, HCV and NASH with or without T2DM and the combination of BI 685509 and empagliflozin in patients with CSPH in compensated cirrhosis due to NASH with T2DM, on top of standard of care respectively. The primary objective is to estimate the percentage change in HVPG from baseline measured after 8 weeks. The primary analysis will be made for treated patients with baseline HVPG measurements (Full Analysis Set, FAS) as if all patients took treatment for the duration of the trial.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Clinical signs of 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. (i) documented endoscopic proof of oesophageal varices and / or gastric varices at screening or within 6 months prior to screening (ii) documented endoscopic-treated oesophageal varices as preventative treatment
- CSPH defined as baseline HVPG ≥ 10 mmHg (measured at Visit 1c), based on a local interpretation of the pressure tracing
- Diagnosis of compensated cirrhosis due to HCV, HBV, 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 x 103/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, US, MRI, 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)
You likely can't join if
- Previous clinically significant decompensation events (e.g. ascites [more than perihepatic ascites], VH and / or overt / apparent 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 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 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
- SBP < 100 mmHg and DBP < 70 mmHg at screening
- Model of End-stage Liver Disease (MELD) score of > 15 at screening, calculated by the central laboratory
See the full eligibility 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
- Clinical signs of 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. (i) documented endoscopic proof of oesophageal varices and / or gastric varices at screening or within 6 months prior to screening (ii) documented endoscopic-treated oesophageal varices as preventative treatment
- CSPH defined as baseline HVPG ≥ 10 mmHg (measured at Visit 1c), based on a local interpretation of the pressure tracing
- Diagnosis of compensated cirrhosis due to HCV, HBV, 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 x 103/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, US, MRI, 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, with no planned dose change throughout the trial
- If receiving treatment with NSBBs or carvedilol must be on a stable dose for at least 1 month prior to screening, with no planned dose change throughout the trial
- Further inclusion criteria apply.
- Previous clinically significant decompensation events (e.g. ascites [more than perihepatic ascites], VH and / or overt / apparent 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 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 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
- SBP < 100 mmHg and DBP < 70 mmHg at screening
- Model of End-stage Liver Disease (MELD) score of > 15 at screening, calculated by the central laboratory
- Hepatic impairment defined as a Child-Turcotte-Pugh score ≥ B8 at screening, calculated by the site, using central laboratory results
- ALT or AST > 5 times upper limit of normal (ULN) at screening, measured by the central laboratory
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
- United Kingdom
- Canada
- China
- Switzerland
- Singapore
- Argentina
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States; United Kingdom; Canada; China; Switzerland and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.