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NOT YET RECRUITING
NCT07180745
PHASE4

Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease

Sponsor: Badr University

View on ClinicalTrials.gov

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

DRUG

Pioglitazone (PIO)

30 mg orally once daily

DRUG

Empagliflozin

10 mg orally once daily

DRUG

Statin (Atorvastatin)

20 mg orally once daily

DRUG

Empagliflozin plus Statin (Atorvastatin)

Orally once daily of each (10 mg, 20 mg respectively)

DRUG

Pioglitazone plus Atorvastatin

Orally once daily of each (30mg and 20mg respectively)

Locations (1)

Teaching hospital of Beni Suef University

Banī Suwayf, Egypt