Study on BI 685509 and Empagliflozin for Patients with Portal Hypertension in Compensated Cirrhosis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called BI 685509, both alone and in combination with another medication, empagliflozin. The study is aimed at people with a liver condition known as cirrhosis, which is often caused by viral infections like Hepatitis B (HBV) and Hepatitis C (HCV), or by a condition called non-alcoholic steatohepatitis (NASH). These patients also have a complication called portal hypertension, which means there is high blood pressure in the main blood vessel going to the liver. Some participants may also have Type 2 Diabetes Mellitus (T2DM).

The purpose of the study is to investigate the safety and how well people tolerate the medication BI 685509 in patients with significant portal hypertension and compensated cirrhosis, which means the liver is damaged but still able to perform its functions. The study will also look at the effects of combining BI 685509 with empagliflozin in patients with cirrhosis due to NASH and T2DM. Participants will receive treatment for a period of 8 weeks, and the study will measure changes in the pressure within the liver’s blood vessels during this time.

Throughout the study, participants will take the medications in the form of film-coated tablets by mouth. The study will monitor the percentage change in a measurement called HVPG (hepatic venous pressure gradient), which helps assess the severity of portal hypertension. The study will also observe any side effects or complications that may occur during the treatment period. The goal is to better understand how these medications can help manage portal hypertension in people with liver cirrhosis.

1 joining the trial

Upon joining the trial, you will be required to provide a signed and dated written informed consent. This is to ensure that you understand the trial and agree to participate.

You must be between 18 and 75 years old and have clinical signs of **clinically significant portal hypertension (CSPH)**. This includes having a gastroscopy, which is a procedure to look inside your esophagus and stomach, either during the screening period or within 6 months prior to screening.

2 initial assessments

You will undergo initial assessments to confirm your eligibility. This includes measuring your **hepatic venous pressure gradient (HVPG)**, which is a test to measure the blood pressure in your liver.

You must have a diagnosis of compensated cirrhosis due to hepatitis C, hepatitis B, or non-alcoholic steatohepatitis (NASH), with or without type 2 diabetes mellitus (T2DM).

3 treatment phase

During the treatment phase, you will receive **BI 685509** alone or in combination with **empagliflozin**. Both medications are taken orally as film-coated tablets.

The treatment will last for 8 weeks. The exact dosage and frequency will be provided by the trial team based on your specific group assignment.

4 monitoring and follow-up

Throughout the 8-week treatment period, your health will be closely monitored. This includes regular check-ups to assess the effects of the medication and to ensure your safety.

The primary goal is to observe any changes in your **HVPG** from the baseline measurement. Secondary observations include any reduction in HVPG by more than 10%, and monitoring for any side effects such as low blood pressure or fainting.

5 end of trial

At the end of the trial, a final assessment will be conducted to evaluate the overall effects of the treatment.

You will be informed about the results and any further steps if necessary.

Who Can Join the Study?

Signed and dated written informed consent before joining the trial.
Must be a male or female aged between 18 and 75 years old at the time of screening.
Must show clinical signs of CSPH (Clinically Significant Portal Hypertension). This can be shown by:
- Endoscopic proof of oesophageal varices (swollen veins in the esophagus) or gastric varices (swollen veins in the stomach) during screening or within 6 months before screening.
- Endoscopic-treated oesophageal varices as preventative treatment.
CSPH must be defined as a baseline HVPG (Hepatic Venous Pressure Gradient) of 10 mmHg or more, measured at Visit 1c.
Must have a diagnosis of compensated cirrhosis (a type of liver disease) due to HCV (Hepatitis C Virus), HBV (Hepatitis B Virus), or NASH (Non-Alcoholic Steatohepatitis) with or without T2DM (Type 2 Diabetes Mellitus). The diagnosis of cirrhosis can be based on:
- Histology (study of tissues) from past data.
- Clinical evidence like low platelet count, nodular liver surface on imaging, or enlarged spleen.
Diagnosis of NASH can be based on:
- Current or past histological diagnosis of NASH or steatosis (fatty liver).
- Clinical diagnosis of NASH based on imaging showing fatty liver and at least two other conditions related to metabolic syndrome (like being overweight, having T2DM, high blood pressure, or high cholesterol).
Must be willing and able to undergo HVPG measurements as per the study protocol.
If taking statins (medications to lower cholesterol), must be on a stable dose for at least 3 months before screening, with no planned dose changes during the trial.
If taking NSBBs (Non-Selective Beta-Blockers) or carvedilol (a type of beta-blocker), must be on a stable dose for at least 1 month before screening, with no planned dose changes during the trial.
Further inclusion criteria may apply.

Who Cannot Join the Study?

Patients with portal hypertension cannot participate. This is a condition where there is increased blood pressure in the portal vein, which carries blood from the digestive organs to the liver.
Patients with compensated cirrhosis due to HBV (Hepatitis B Virus), HCV (Hepatitis C Virus), or NASH (Non-Alcoholic Steatohepatitis) are excluded. Cirrhosis is a late stage of scarring (fibrosis) of the liver.
Patients with T2DM (Type 2 Diabetes Mellitus) are excluded. This is a condition that affects the way the body processes blood sugar (glucose).
Patients who are part of a vulnerable population are excluded. This refers to groups who may be at a higher risk of harm or exploitation in a clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Medizinische Hochschule Hannover	Hanover	Germany
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Hopital Beaujon	Clichy	France
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj	Cluj Napoca	Romania
Complexo Hospitalario Universitario De Pontevedra	Pontevedra	Spain
Akcgklyqo Uic	Amsterdam	The Netherlands
Ucyviiftdfwygkzzlnnbj Mcdxhpfp Avx	Munster	Germany
Gxytfv Uqjsnethpg Fouqkdcpi	Frankfurt	Germany
Utspmprxny Ob Aonkvgj	Edegem	Belgium
Hdeygyyg Hwracpaa	Hvidovre	Denmark
Hclwpbjv Vait dbsmfiwt	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	28.07.2023
Belgium	Not recruiting	28.07.2023
Denmark	Not recruiting	28.07.2023
France	Not recruiting	28.07.2023
Germany	Not recruiting	28.07.2023
Italy	Not recruiting	28.07.2023
Romania	Not recruiting	28.07.2023
Spain	Not recruiting	28.07.2023
The Netherlands	Not recruiting	28.07.2023

Trial locations

Investigated drugs:

BI 685509 is a medication being studied to see how it affects a condition called portal hypertension, which is high blood pressure in the veins that carry blood to the liver. This condition can happen in people with liver problems like cirrhosis. The trial is looking at how safe and tolerable this medication is for patients, and how it might help reduce the high blood pressure in these veins.

Empagliflozin is a medication that is usually used to help control blood sugar levels in people with type 2 diabetes. In this trial, it is being used in combination with BI 685509 to see if it can help further reduce portal hypertension in patients who have liver problems and type 2 diabetes. The study is exploring whether using these two medications together can provide better results for patients with these conditions.

Investigated diseases:

Portal hypertension

Portal Hypertension – Portal hypertension is a condition characterized by increased blood pressure within the portal venous system, which includes the veins coming from the stomach, intestine, spleen, and pancreas that merge into the portal vein. This condition often arises due to liver cirrhosis, where scar tissue obstructs blood flow through the liver. As the pressure builds, it can lead to the development of enlarged veins, known as varices, in the esophagus and stomach, which are prone to bleeding. Over time, portal hypertension can cause fluid accumulation in the abdomen, known as ascites, and may also lead to splenomegaly, an enlargement of the spleen. The increased pressure can also affect the brain, leading to hepatic encephalopathy, which involves confusion and altered levels of consciousness. The progression of portal hypertension is typically gradual, correlating with the underlying liver disease’s advancement.

Trial ID:

2023-504257-12-00

Protocol code:

1366-0029

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on BI 685509 and Empagliflozin for Patients with Portal Hypertension in Compensated Cirrhosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?