Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBadr University

About this trial

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

Eligibility criteria

Qualifiers

Adult

Obese

Hyperlipidemic

Diabetic patients

Disqualifiers

Pregnant women

Breast feeding women

Diabetic patients with ketoacidosis

Hyperlipidemic patients with cardiovascular dysfunction

Trial design

Treatments tested in this trial

  • Pioglitazone (PIO)
  • Empagliflozin
  • Statin (Atorvastatin)
  • Empagliflozin plus Statin (Atorvastatin)
  • Pioglitazone plus Atorvastatin

Treatment groups

400 Participants
are divided into 5 treatment groups

Sponsors and collaborators