Study on Empagliflozin for Patients with Non-Alcoholic Steatohepatitis (NASH)

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What is this study about?

This clinical trial is focused on studying a liver condition known as Non-Alcoholic Steatohepatitis (NASH), which is a type of liver inflammation and damage caused by a buildup of fat in the liver. The study will use a medication called Jardiance, which contains the active ingredient empagliflozin. Jardiance is typically used to treat type 2 diabetes, but this study aims to explore its effects on NASH.

The purpose of the study is to evaluate how Jardiance affects the liver condition over a period of 48 weeks. Participants will take Jardiance in the form of film-coated tablets. The study will monitor changes in the liver’s condition, specifically looking at the histological grade, which refers to the microscopic examination of liver tissue, and the stage of NASH. The study will also assess any changes in liver fibrosis, which is the thickening and scarring of liver tissue, using a non-invasive method called liver elastography. Additionally, improvements in laboratory results and physical measurements will be observed.

Participants in the study will be monitored throughout the 48-week period to track any changes in their liver condition and overall health. The study aims to provide valuable insights into whether Jardiance can be an effective treatment for NASH, potentially offering a new therapeutic option for individuals with this liver condition.

1 joining the study

Upon joining the study, you will be asked to sign an informed consent form. This confirms your understanding of the study and your willingness to participate.

You must be between 18 and 75 years old and have a verified diagnosis of non-alcoholic steatohepatitis (NASH) determined by a liver biopsy within the last six months.

2 initial assessment

An initial assessment will be conducted to evaluate your health status. This includes checking your HbA1c levels, which should be 80 mmol/mol or lower.

If you are a woman of childbearing age, you will need to agree to use at least two contraceptive methods during the study.

3 medication administration

You will begin taking Jardiance 10 mg film-coated tablets, which contain the active substance empagliflozin.

The medication is taken orally once a day for a duration of 48 weeks.

4 regular follow-up visits

Throughout the 48-week period, you will have regular follow-up visits to monitor your progress.

These visits will include assessments of your liver health using non-invasive techniques and laboratory tests to track any changes.

5 final evaluation

At the end of the 48-week period, a final evaluation will be conducted to assess the impact of the medication on your liver health.

The primary goal is to observe a decrease in the histological score of NASH, with secondary goals including a reduction in liver fibrosis and improvements in laboratory results.

Who Can Join the Study?

The ability and eligibility to sign an informed consent form, which means you understand the study and agree to participate.
Age between 18 and 75 years at the start of the study.
A confirmed or ruled out diagnosis of Type 2 Diabetes Mellitus (DM2T) based on specific tests (OGTT HbA1c).
A confirmed diagnosis of Non-Alcoholic Steatohepatitis (NASH) through a liver tissue examination (histology) done within the last 6 months.
The activity of NASH must be measured by the NAFLD Activity Score (NAS), which is a way to assess liver disease severity.
A blood sugar level (HbA1c) of less than or equal to 80 mmol/mol.
If you are a woman who can have children, you must be willing to use at least two methods of birth control.

Who Cannot Join the Study?

Patients who have any other serious liver diseases besides Metabolic dysfunction-associated steatohepatitis (NASH).
Patients who have a history of alcohol or drug abuse.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients who have a known allergy to the study medication or its ingredients.
Patients who have uncontrolled diabetes or other serious medical conditions that could interfere with the study.
Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not yet recruiting	01.04.2024

Trial locations

Investigated drugs:

Empagliflozin

Empagliflozin is a medication used in this clinical trial to help reduce the severity of Non-Alcoholic Steatohepatitis (NASH), a liver condition. It works by helping the body remove excess sugar through urine, which can also lead to weight loss and improved liver health. The trial aims to see how well empagliflozin can improve the liver condition over a 48-week period.

Metabolic dysfunction-associated steatohepatitis – This disease is characterized by the accumulation of fat in the liver, accompanied by inflammation and liver cell damage. It is a more severe form of non-alcoholic fatty liver disease (NAFLD). Over time, the inflammation can lead to scarring of the liver tissue, known as fibrosis. If the condition progresses, it can result in cirrhosis, where the liver becomes severely scarred and its function is impaired. The disease is often associated with obesity, insulin resistance, and metabolic syndrome. It can develop without significant alcohol consumption, distinguishing it from alcoholic liver disease.

Trial ID:

2024-518334-88-00

Protocol code:

RedNASH2023

NCT ID:

NCT06519448

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Empagliflozin for Patients with Non-Alcoholic Steatohepatitis (NASH)

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