Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease

NCT07180745 | Not Yet Recruiting Phase 4

• 1 other identifier: FMBSUREC/01092024
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Non-alcoholic Fatty Liver Disease NAFLD; Non-alcoholic Steatohepatitis NASH

Keywords

Empagliflozin; Statin; Pioglitazone; NAFLD; NASH

Outcome Measures

Primary Outcomes (2)

• The controlled attenuation parameter (CAP).

  The CAP value is expressed in dB/m.

  After 3 months

• The liver stiffness measurement (LSM) using FibroScan®.

  The LSM value is expressed as kilopascal or kPa.

  After 3 months

Secondary Outcomes (1)

• Fibrosis-4 (FIB-4) index

  After 3 months

Study Arms (5)

Pioglitazone

ACTIVE COMPARATOR

30 mg once daily orally for 3 months

Drug: Pioglitazone (PIO)

Empagliflozin

ACTIVE COMPARATOR

10 mg once daily orally for 3 months

Drug: Empagliflozin

Statins

ACTIVE COMPARATOR

Once daily orally for 3 months

Drug: Statin (Atorvastatin)

Empagliflozin plus statins

ACTIVE COMPARATOR

Once daily orally for 3 months

Drug: Empagliflozin plus Statin (Atorvastatin)

Pioglitazone plus Statins

ACTIVE COMPARATOR

Once daily orally for 3 months

Drug: Pioglitazone plus Atorvastatin

Interventions

Pioglitazone (PIO) DRUG

30 mg orally once daily

Pioglitazone

Empagliflozin DRUG

10 mg orally once daily

Empagliflozin

Statin (Atorvastatin) DRUG

20 mg orally once daily

Statins

Empagliflozin plus Statin (Atorvastatin) DRUG

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

Empagliflozin plus statins

Pioglitazone plus Atorvastatin DRUG

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

Pioglitazone plus Statins

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult
• Obese
• Hyperlipidemic
• Diabetic patients
• Diagnosed with non-alcoholic fatty liver disease and non-alcoholic Steatohepatitis

You may not qualify if:

• Pregnant women
• Breast feeding women
• Diabetic patients with ketoacidosis
• Hyperlipidemic patients with cardiovascular dysfunction
• Patients with NAFLD or NASH induced hepatocellular carcinoma
• Hyperlipidemic obese diabetic patients diagnosed with NAFLD or NASH who will refuse to sign the informed consent

Sponsors & Collaborators

• Badr University: lead

Study Sites (1)

Teaching hospital of Beni Suef University

Banī Suwayf, 62727, Egypt

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Pioglitazone; empagliflozin; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Pyrroles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Eman Swan

  Badr University in Cairo, Faculty of Pharmacy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Swan, PHD

CONTACT

+201090111013; eman.said@buc.edu.eg

Raghda Hussien, PHD

CONTACT

+201010647666; Raghda.hussien@pharm.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: November 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)