Enrolling by invitation

RedNASHEmpagliflozin for Non-Alcoholic Steatohepatitis

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Study Aim

This study aims to assess how well empagliflozin treatment changes liver activity in people with non-alcoholic steatohepatitis over a 12-month period.

What is being tested

Empagliflozin 10 miligrams (mg)

Drug
Who is being recruted

Diabetes Mellitus+11

+ Diabetes Mellitus, Type 2

+ Digestive System Diseases

From 18 to 75 Years
+28 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2024
See protocol details

Summary

Principal SponsorMilitary University Hospital, Prague
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2024

Actual date on which the first participant was enrolled.

This clinical trial aims to determine whether empagliflozin, a medication typically used to treat diabetes, can help improve liver health in adults with non-alcoholic steatohepatitis (NASH). NASH is a liver condition that can lead to serious liver damage, and currently, treatment options are limited. By exploring the effects of empagliflozin over a 48-week period, this study hopes to find a new and effective way to manage this condition. It is important because finding a successful treatment could significantly improve the quality of life for those affected by NASH. Participants in the study will take the drug empagliflozin daily for one year. They will attend regular clinic visits at specific intervals—weeks 1, 2, 4, 12, 24, 36, and 48—to monitor their health and the medication's effects. These visits include a variety of assessments such as blood tests, measurements of liver stiffness using non-invasive methods, and checks on their overall physical health. The study evaluates changes in the liver's condition and overall health indicators to determine if empagliflozin is beneficial in treating NASH. While potential benefits include improved liver health, the study also carefully monitors for any adverse effects throughout the treatment period.

Official TitleReducing Non-Alcoholic Steatohepatitis Study
Principal SponsorMilitary University Hospital, Prague
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Digestive System DiseasesEndocrine System DiseasesFatty LiverFibrosisLiver CirrhosisLiver DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersNon-alcoholic Fatty Liver Disease

Criteria

6 inclusion criteria required to participate
Ability and eligibility to provide informed consent.

Age between 18 and 75 years at the time of study initiation.

Confirmed or excluded diagnosis of type 2 diabetes mellitus (DM2) according to the target group (OGTT test, HbA1c).

Diagnosis of NASH confirmed by a central pathologist based on histological evaluation of a liver biopsy performed within 3 months prior to the initiation of the investigational drug. - The evaluation must include determination of the process activity according to the NAFLD Activity Score (NAS).

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22 exclusion criteria prevent from participating
Contraindication to liver biopsy.

Documented episode of ketoacidosis.

Contraindication or hypersensitivity to empagliflozin.

Presence of acute or chronic illness that, in the investigator's opinion, could jeopardize the health or safety of the patient.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients with histological proven NASH (either diabetics and non-diabetics).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Central Military Hospital

Prague, CzechiaOpen Central Military Hospital in Google Maps
Enrolling by invitationOne Study Center