Non-alcoholic SteatohepatitisRedNASHNCT06519448
Reducing Non-Alcoholic Steatohepatitis
A study testing Empagliflozin 10 miligrams (mg) in people with Non-alcoholic Steatohepatitis and Liver Diseases, run by Military University Hospital, Prague at 1 site in Czechia.
Trial summary
The goal of this clinical trial is to learn if empagliflozin works to treat non-alcoholic steatohepatitis in adults. The objectives are: Primary Objective To evaluate the change in histological grading and staging of NASH in patients with confirmed non-alcoholic steatohepatitis (NASH) treated with empagliflozin for a… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis, Liver Diseases, Diabetes Mellitus, Type 2
- What is being tested?
- Empagliflozin 10 miligrams (mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- HbA1c value ≤ 80 mmol/mol.
- For women of childbearing potential, willingness to use at least two adequate methods of contraception.
Who cannot join
- 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.
- HbA1c value > 80 mmol/mol.
- Inability to safely discontinue thiazolidinedione (pioglitazone) therapy.
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- Liver disease of other etiologies, including viral hepatitis B and C, autoimmune hepatitis, alpha-1 antitrypsin deficiency, hemochromatosis, Wilson's disease, primary sclerosing cholangitis, primary biliary cholangitis, or liver cirrhosis (Child-Pugh A, B, C) of any etiology.
- Use of medications or medical procedures that induce liver steatosis or fibrosis.
- Proven alcohol use exceeding: Men > 30 g/day, Women > 20 g/day.
- History of acute or chronic pancreatitis.
- Known dependence on or use of illegal addictive substances.
- Significant weight gain or loss: +/- 10% in the last three months.
- Diagnosis of malignant disease (except treated benign or skin tumors) in the last 5 years.
- Stroke or myocardial infarction in the last 6 months.
- Clinically significant dyspnea New York hear association (NYHA) grade III or higher.
- Proven heart failure with a left ventricular ejection fraction below 40%.
- estimated glomerular filtration rate(eGFR) values lower than 30 ml/min/1.73 m² or creatinine clearance lower than 30 ml/min.
- Proven diabetic foot syndrome requiring amputation or with an existing defect.
- Planned pregnancy, ongoing lactation or pregnancy, positive pregnancy test, lack of at least two adequate contraceptive methods in women of childbearing potential.
- Participation in another interventional study within the last 3 months before study entry.
- Legal incapacity or reduced ability to perform legal acts.
- Serving a prison sentence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reducing Non-Alcoholic Steatohepatitis Study
The goal of this clinical trial is to learn if empagliflozin works to treat non-alcoholic steatohepatitis in adults. The objectives are:
Primary Objective To evaluate the change in histological grading and staging of NASH in patients with confirmed non-alcoholic steatohepatitis (NASH) treated with empagliflozin for a duration of 48 weeks.
Read more
Secondary Objective To evaluate the change in findings from non-invasive liver elasticity measurements, laboratory tests, and anthropometric assessments after 48 weeks of empagliflozin administration.
Participants will:
Take empagliflozin every day for 12 months. Visit the clinic according to a protocol at weeks: 1, 2, 4, 12, 24, 36, 48 Visits includes checkups and tests (blood count, basic biochemistry, glycosylated hemoglobin, anthropometry, non-invasive liver stiffness measurement).
- Being tested
- Empagliflozin 10 miligrams (mg)
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases, Diabetes Mellitus, Type 2, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 miligrams (mg)Drug
Use of empagliflozin 10 mg daily for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| NASH | Experimental | Patients with histological proven NASH (either diabetics and non-diabetics). Receives: Drug: Empagliflozin 10 miligrams (mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in histological activity after 12-month treatment with empagliflozin
Non-alcoholic Fatty Liver Disease Activity Score (NAS) change after intervention. The NAS can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2). In patients with NAFLD, NAS score of ≥ 5 strongly correlated with a diagnosis of "definite NASH" whereas NAS ≤ 3 correlated with a diagnosis of "not NASH".
Measured: 12 months
Secondary outcomes (8)
Change of liver stiffness
Liver stiffness measured in kilopascals (kPa) by transient elastography at baseline and after intervention.
Measured: 12 months
Change of liver steatosis
Continuous attenuation parameter measured in decibels per meter (dB/m) at baseline and after intervention.
Measured: 12 months
Anthropometry (body weight)
Measurement of body weight measured in kilograms (kg) and change from baseline.
Measured: 12 months
Anthropometry (height)
Measurement of body height measured in metres (m) to calculate Body Mass Index (BMI).
Measured: 12 months
Anthropometry (BMI)
Change in BMI from baseline (measured in kg/m^2).
Measured: 12 months
Liver functional tests
Change in activity liver functional tests (LFT) all measured in microkatals per liter (ucat/L) from baseline.
These tests comprise:
Alanine transaminase (ALT) Aspartate transaminase (AST) Gamma-glutamyl transferase (GGT) Alkaline phosphatase (ALP)
Measured: 12 months
Bilirubin level
Change in activity concentration of bilirubin measured in micromoles per liter (umol/L) from baseline.
Measured: 12 months
Lipidogram
Change in cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (measured in mmol/L) from baseline.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Hribek, Military University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519448
- Sponsor's protocol ID
- RedNASH
- Acronym
- RedNASH
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Non-Alcoholic Steatohepatitis Study
- ClinicalTrials.gov ID
- NCT06519448
- Acronym / sponsor ID
- RedNASH / RedNASH
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Military University Hospital, PragueUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if empagliflozin works to treat non-alcoholic steatohepatitis in adults. The objectives are:
Primary Objective To evaluate the change in histological grading and staging of NASH in patients with confirmed non-alcoholic steatohepatitis (NASH) treated with empagliflozin for a duration of 48 weeks.
Secondary Objective To evaluate the change in findings from non-invasive liver elasticity measurements, laboratory tests, and anthropometric assessments after 48 weeks of empagliflozin administration.
Participants will:
Take empagliflozin every day for 12 months. Visit the clinic according to a protocol at weeks: 1, 2, 4, 12, 24, 36, 48 Visits includes checkups and tests (blood count, basic biochemistry, glycosylated hemoglobin, anthropometry, non-invasive liver stiffness measurement).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NASH | Experimental | Drug: Empagliflozin 10 miligrams (mg)Patients with histological proven NASH (either diabetics and non-diabetics). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
- HbA1c value ≤ 80 mmol/mol.
Key exclusion criteria (22 listed)
- 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.
- HbA1c value > 80 mmol/mol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 miligrams (mg)Use of empagliflozin 10 mg daily for 12 months. | Drug | NASH |
Primary outcome
Change in histological activity after 12-month treatment with empagliflozin
Time frame: 12 months
Non-alcoholic Fatty Liver Disease Activity Score (NAS) change after intervention. The NAS can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2). In patients with NAFLD, NAS score of ≥ 5 strongly correlated with a diagnosis of "definite NASH" whereas NAS ≤ 3 correlated with a diagnosis of "not NASH".
8 secondary outcomes
Change of liver stiffness
Time frame: 12 months
Change of liver steatosis
Time frame: 12 months
Anthropometry (body weight)
Time frame: 12 months
Anthropometry (height)
Time frame: 12 months
Anthropometry (BMI)
Time frame: 12 months
Liver functional tests
Time frame: 12 months
Bilirubin level
Time frame: 12 months
Lipidogram
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empagliflozin 10 miligrams (mg) in people with Non-alcoholic Steatohepatitis and Liver Diseases, run by Military University Hospital, Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in histological activity after 12-month treatment with empagliflozin (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.