Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease

Not Applicable

Not yet recruiting

• Conditions: Non-alcoholic Fatty Liver Disease NAFLD; Non-alcoholic Steatohepatitis NASH
• Interventions: Drug: Pioglitazone (PIO); Drug: Empagliflozin; Drug: Statin (Atorvastatin); Drug: Empagliflozin plus Statin (Atorvastatin); Drug: Pioglitazone plus Atorvastatin

• Registration Number: NCT07180745
• Lead Sponsor: Badr University

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

Detailed Description

NAFLD is a growing global health problem linked with metabolic issues like obesity, diabetes, and insulin resistance. It ranges from simple liver fat accumulation to NASH, involving inflammation and liver damage, progressing to fibrosis, cirrhosis, and cancer. Managing NAFLD is tough due to diagnosis challenges and metabolic complications. Lifestyle changes like diet and exercise are key but often hard to sustain. No FDA-approved treatments exist yet, but drugs like Empagliflozin and statins are being studied for their potential to improve insulin sensitivity, reduce liver inflammation, and slow disease progression. This study compares these therapies for NAFLD and NASH.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Study Start: 2025-11-01
• Primary Completion: 2026-02-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pioglitazone	Pioglitazone (PIO)	30 mg once daily orally for 3 months
Empagliflozin	Empagliflozin	10 mg once daily orally for 3 months
Statins	Statin (Atorvastatin)	Once daily orally for 3 months
Empagliflozin plus statins	Empagliflozin plus Statin (Atorvastatin)	Once daily orally for 3 months
Pioglitazone plus Statins	Pioglitazone plus Atorvastatin	Once daily orally for 3 months

Primary Outcome Measures

Name	Time	Method
The controlled attenuation parameter (CAP).	After 3 months	The CAP value is expressed in dB/m.
The liver stiffness measurement (LSM) using FibroScan®.	After 3 months	The LSM value is expressed as kilopascal or kPa.

Secondary Outcome Measures

Name	Time	Method
Fibrosis-4 (FIB-4) index	After 3 months	FIB-4 is a non-invasive scoring system that can predict significant hepatic fibrosis patients.

Trial Locations

Locations (1)

Teaching hospital of Beni Suef University; 🇪🇬 Banī Suwayf, Egypt