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Clinical Trial Details

Trial ID: L2413
Source ID: NCT06519448
Associated Drug: Empagliflozin 10 Miligrams (Mg)
Title: Reducing Non-Alcoholic Steatohepatitis
Acronym: RedNASH
Status: ENROLLING_BY_INVITATION
Study Results: NO
Results:
Conditions: Non-alcoholic Steatohepatitis|Liver Diseases|Diabetes Mellitus, Type 2|Fibrosis, Liver
Interventions: DRUG: Empagliflozin 10 miligrams (mg)
Outcome Measures: Primary: 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: Change of liver stiffness, Liver stiffness measured in kilopascals (kPa) by transient elastography at baseline and after intervention., 12 months|Change of liver steatosis, Continuous attenuation parameter measured in decibels per meter (dB/m) at baseline and after intervention., 12 months|Anthropometry (body weight), Measurement of body weight measured in kilograms (kg) and change from baseline., 12 months|Anthropometry (height), Measurement of body height measured in metres (m) to calculate Body Mass Index (BMI)., 12 months|Anthropometry (BMI), Change in BMI from baseline (measured in kg/m\^2)., 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), 12 months|Bilirubin level, Change in activity concentration of bilirubin measured in micromoles per liter (umol/L) from baseline., 12 months|Lipidogram, Change in cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (measured in mmol/L) from baseline., 12 months
Sponsor/Collaborators: Sponsor: Military University Hospital, Prague
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2027-12-31
Results First Posted:
Last Update Posted: 2024-07-25
Locations: Central Military Hospital, Prague, 16902, Czechia
URL: https://clinicaltrials.gov/show/NCT06519448