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Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease
Sponsor: Badr University
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
Official title: Assessment of Efficacy of Empagliflozin Versus Statins in Treatment of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2025-11-01
Completion Date
2026-03-01
Last Updated
2025-09-18
Healthy Volunteers
No
Interventions
Pioglitazone (PIO)
30 mg orally once daily
Empagliflozin
10 mg orally once daily
Statin (Atorvastatin)
20 mg orally once daily
Empagliflozin plus Statin (Atorvastatin)
Orally once daily of each (10 mg, 20 mg respectively)
Pioglitazone plus Atorvastatin
Orally once daily of each (30mg and 20mg respectively)
Locations (1)
Teaching hospital of Beni Suef University
Banī Suwayf, Egypt