Reducing Non-Alcoholic Steatohepatitis

NCT06519448 | Enrolling By Invitation

• 1 other identifier: RedNASH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Non-alcoholic Steatohepatitis; Liver Diseases; Diabetes Mellitus, Type 2; Fibrosis, Liver

Outcome Measures

Primary Outcomes (1)

• 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".

  12 months

Secondary Outcomes (8)

• Change of liver stiffness

  12 months

• Change of liver steatosis

  12 months

• Anthropometry (body weight)

  12 months

• Anthropometry (height)

  12 months

• Anthropometry (BMI)

  12 months

Study Arms (1)

NASH

EXPERIMENTAL

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

Drug: Empagliflozin 10 miligrams (mg)

Interventions

Empagliflozin 10 miligrams (mg) DRUG

Use of empagliflozin 10 mg daily for 12 months.

NASH

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Military University Hospital, Prague: lead

Study Sites (1)

Central Military Hospital

Prague, 16902, Czechia

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases; Diabetes Mellitus, Type 2; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 25, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

CZ (1)