Clinical Trial

Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease

Not Yet Recruiting Phase 4
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Record status
This record was last updated September 18, 2025 (before its estimated February 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to assess the efficacy of Empagliflozin versus Statins as monotherapy and polytherapy in non-alcoholic fatty liver disease and non-alcoholic Steatohepatitis. Does drug ABC Empagliflozin versus Statins as monotherapy and polytherapy improve the controlled attenuation parameter (CAP), the liver stiffness measurement (LSM), the proportion of patients with at least one point improvement or one-stage reduction in the histological scores with respect to hepatic steatosis, hepatocellular ballooning, lobular inflammation, and fibrosis after treatment? What medical problems do participants have when taking Empagliflozin versus Statins as monotherapy and polytherapy? Participants will: * Take Empagliflozin alone or Empagliflozin plus statins or Pioglitazone plus Statins or Pioglitazone alone as standard therapy every day for 3 months * Be directed to complete history taking. FibroScan®, abdominal ultrasound and laboratory tests of ALT, AST, ALP, platelets count, Triglycerides, Cholesterol, LDL, HDL, serum insulin and insulin resistance will be conducted at baseline and after the drug administration for 3 months. * Keep a diary of recording any side effects they use a rescue inhaler
Trial Details
NCT Number NCT07180745
Lead Sponsor Badr University
Conditions Non-alcoholic Fatty Liver Disease NAFLD, Non-alcoholic Steatohepatitis NASH
Enrollment 400 participants
Start Date 2025-11-01
Primary Completion 2026-02-01 (estimated)
Study Completion 2026-03-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-18