AuthorisedTherapeutic use (Phase IV)Interventional

Reducing Non-Alcoholic Steatohepatitis

This research is investigating a medicine called Jardiance, which is already used for other health conditions. The study focuses on people who have a liver condition known as non-alcoholic steatohepatitis, or NASH. In NASH, there's a build-up of fat in the liver, leading to inflammation and damage. The main goal is to see if Jardiance can improve the health of the liver, specifically by reducing liver damage and scarring. Researchers will also look at how liver scarring might change using special scans and check if blood tests and body measurements improve. This is an important step to find better ways to help people living with NASH.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha

Enrolment target

Start

08 Oct 2024

Metabolic dysfunction-associated steatohepatitis

What is this study about?

This research is focused on a liver condition called non-alcoholic steatohepatitis, often shortened to NASH. NASH is a more serious type of 'fatty liver disease,' where too much fat builds up in the liver, causing inflammation and damage. Over time, this can lead to serious problems like scarring of the liver, known as fibrosis, and even liver failure.

The study is looking at a medicine called Jardiance (its active ingredient is empagliflozin). This medicine is already approved for other conditions, but researchers want to see if it can specifically help people with NASH. The main thing they want to find out is if Jardiance can improve how the liver looks under a microscope, by reducing the signs of damage and inflammation.

They will also be checking other important things, like whether the medicine helps reduce liver scarring. This will be measured using special non-invasive scans that can assess the stiffness of the liver, which indicates scarring. The researchers will also keep an eye on routine blood test results and body measurements to see if there are any improvements related to the medicine.

Key takeaways

The study is about a medicine called Jardiance for people with NASH (fatty liver disease).
It aims to see if Jardiance can improve liver damage and reduce scarring.
People aged 18 and over with an NASH diagnosis can potentially join.
The study involves taking Jardiance and having regular check-ups.
There are potential benefits and potential risks, which will be fully explained.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning people of all adult ages can be considered. Both men and women are welcome to participate.

The most important requirement is that you have a diagnosis of metabolic dysfunction-associated steatohepatitis (MASH), which is the new name for non-alcoholic steatohepatitis (NASH).

There might be other health conditions or medications that could prevent you from joining the study, even if you meet these general criteria. These details would be discussed with you by the study team.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of metabolic dysfunction-associated steatohepatitis (NASH)?
Are you able to attend regular study appointments?
Are you comfortable taking a tablet medicine daily?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be given the medicine Jardiance in the form of a 10 mg tablet to take. This is a therapeutic use study, meaning the medicine is being used in a way that is already approved for other conditions, but its use for NASH is still being studied in this context. You would have regular visits to the study clinic where various assessments would be carried out. These assessments would likely include blood tests, physical examinations, and possibly non-invasive scans to check your liver health. The study team would explain the exact schedule of visits and assessments, as well as the total length of your participation, before you make any commitment.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as contributing to scientific knowledge about NASH and potentially improving your liver health. However, as with any medicine, there are potential risks and side effects associated with Jardiance. The study team will explain these in detail, including less common but more serious risks. You will also have the right to withdraw from the study at any time, for any reason, without it affecting your medical care, if you decide it's no longer right for you.

Locations (1)

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Czechia

Common questions

What is NASH?

NASH (Non-alcoholic steatohepatitis) is a liver condition where too much fat builds up, causing inflammation and damage, which can lead to scarring.

What is Jardiance?

Jardiance is a medicine that is already used for other health conditions. This study is exploring if it can also help people with NASH.

Will I receive the actual medicine or a dummy pill?

In this specific 'Phase IV' type of study, participants generally receive the active medicine being studied, which is Jardiance, at a specific dose of 10 mg.

How will they know if the medicine is working?

Researchers will check your liver health using special scans, blood tests, and by looking at changes in your liver tissue under a microscope.

What does 'non-invasive liver elastography' mean?

This is a special scan, like an ultrasound, that can measure how stiff your liver is. A stiffer liver can be a sign of scarring.