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Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease

ConditionsNon-alcoholic Fatty Liver Disease NAFLDNon-alcoholic Steatohepatitis NASH
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

This trial does not accept healthy volunteers

Qualifiers

Adult

Obese

Hyperlipidemic

Diabetic patients

Disqualifiers

Pregnant women

Breast feeding women

Diabetic patients with ketoacidosis

Hyperlipidemic patients with cardiovascular dysfunction

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pioglitazone (PIO)

    Drug

    30 mg orally once daily

  • Empagliflozin

    Drug

    10 mg orally once daily

  • Statin (Atorvastatin)

    Drug

    20 mg orally once daily

  • Empagliflozin plus Statin (Atorvastatin)

    Drug

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

  • Pioglitazone plus Atorvastatin

    Drug

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

Treatment groups

400 Participants
are divided into 5 treatment groups
Group A: PioglitazoneActive comparator 1 intervention
Group B: EmpagliflozinActive comparator 1 intervention
Group C: StatinsActive comparator 1 intervention
Group D: Empagliflozin plus statinsActive comparator 1 intervention
Group E: Pioglitazone plus StatinsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The controlled attenuation parameter (CAP).

The CAP value is expressed in dB/m.

Time frame
After 3 months
2

The liver stiffness measurement (LSM) using FibroScan®.

The LSM value is expressed as kilopascal or kPa.

Time frame
After 3 months

Secondary outcomes

1

Fibrosis-4 (FIB-4) index

FIB-4 is a non-invasive scoring system that can predict significant hepatic fibrosis patients.

Time frame
After 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Badr University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: