NCT07180745

Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease

Assessment of Efficacy of Empagliflozin Versus Statins in Treatment of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Badr University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-02-01
• Completion: 2026-03-01
• First posted: 2025-09-18
• Last updated: 2025-09-18

Locations

1 site across 1 country: Egypt