NCT07180745Not yet recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 18 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 11 Sept 2025
- Start date
- 1 Nov 2025
- Primary completion date
- 1 Feb 2026
- Lead sponsor
- Badr University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07180745
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 400
- From 1 Nov 2025 to the primary completion date, 1 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- Adult
- Obese
- Hyperlipidemic
- Diabetic patients
- Diagnosed with non-alcoholic fatty liver disease and non-alcoholic Steatohepatitis
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Teaching hospital of Beni Suef University Coordinator of this site? Confirm its status | Banī Suwayf | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.