Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07180745

Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Non-alcoholic Fatty Liver Disease NAFLD Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis NASH

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. The controlled attenuation parameter (CAP).

    Time frame: After 3 months

    The CAP value is expressed in dB/m.

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

    Time frame: After 3 months

    The LSM value is expressed as kilopascal or kPa.

Secondary outcomes

  1. Fibrosis-4 (FIB-4) index

    Time frame: After 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Eman Swan, PHD

CONTACT

[email protected]

+201090111013

Raghda Hussien, PHD

CONTACT

[email protected]

+201010647666

Sponsors and collaborators

Lead sponsor

Badr University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.