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Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease

NCT07180745 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-09-18

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Badr University

    lead OTHER

Principal Investigators

  • Eman Swan · Badr University in Cairo, Faculty of Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-02-01
Completion
2026-03-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07180745 on ClinicalTrials.gov