Non-alcoholic Fatty Liver Disease NAFLDPhase 4NCT07180745
Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease
A Phase 4 study testing Pioglitazone (PIO), Empagliflozin and Statin (Atorvastatin) in people with Non-alcoholic Fatty Liver Disease NAFLD and Non-alcoholic Steatohepatitis NASH, run by Badr University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease NAFLD, Non-alcoholic Steatohepatitis NASH
- What is being tested?
- Pioglitazone (PIO), Empagliflozin and Statin (Atorvastatin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2025to 1 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- Obese
- Hyperlipidemic
- Diabetic patients
- Diagnosed with non-alcoholic fatty liver disease and non-alcoholic Steatohepatitis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Teaching hospital of Beni Suef University
Banī Suwayf, 62727
Raghda Hussien, PHD, +201010647666, Raghda.hussien@pharm.bsu.edu.eg
Raghda Hussien, PHD, Raghda.hussien@pharm.bsu.edu.eg
About this study
Official title: Assessment of Efficacy of Empagliflozin Versus Statins in Treatment of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis
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?
Read more
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
Read the 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.
- Being tested
- Pioglitazone (PIO), Empagliflozin, Statin (Atorvastatin), Empagliflozin plus Statin (Atorvastatin), Pioglitazone plus Atorvastatin
- Keywords
- Empagliflozin, Statin, Pioglitazone, NAFLD, NASH
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone (PIO)Drug
30 mg orally once daily
EmpagliflozinDrug
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 AtorvastatinDrug
Orally once daily of each (30mg and 20mg respectively)
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Active comparator | 30 mg once daily orally for 3 months Receives: Drug: Pioglitazone (PIO) |
| Empagliflozin | Active comparator | 10 mg once daily orally for 3 months Receives: Drug: Empagliflozin |
| Statins | Active comparator | Once daily orally for 3 months Receives: Drug: Statin (Atorvastatin) |
| Empagliflozin plus statins | Active comparator | Once daily orally for 3 months Receives: Drug: Empagliflozin plus Statin (Atorvastatin) |
| Pioglitazone plus Statins | Active comparator | Once daily orally for 3 months Receives: Drug: Pioglitazone plus Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The controlled attenuation parameter (CAP).
The CAP value is expressed in dB/m.
Measured: After 3 months
The liver stiffness measurement (LSM) using FibroScan®.
The LSM value is expressed as kilopascal or kPa.
Measured: After 3 months
Secondary outcomes (1)
Fibrosis-4 (FIB-4) index
FIB-4 is a non-invasive scoring system that can predict significant hepatic fibrosis patients.
Measured: After 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver Disease NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Said Sawan, Badr University
- Investigators
- Eman Swan, Principal investigator, Badr University in Cairo, Faculty of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180745
- Sponsor's protocol ID
- FMBSUREC/01092024
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available with corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy of Empagliflozin Versus Statins in Treatment of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT07180745
- Acronym / sponsor ID
- FMBSUREC/01092024
- Keywords
- Empagliflozin, Statin, Pioglitazone, NAFLD, NASH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Active comparator | Drug: Pioglitazone (PIO)30 mg once daily orally for 3 months |
| Empagliflozin | Active comparator | Drug: Empagliflozin10 mg once daily orally for 3 months |
| Statins | Active comparator | Drug: Statin (Atorvastatin)Once daily orally for 3 months |
| Empagliflozin plus statins | Active comparator | Drug: Empagliflozin plus Statin (Atorvastatin)Once daily orally for 3 months |
| Pioglitazone plus Statins | Active comparator | Drug: Pioglitazone plus AtorvastatinOnce daily orally for 3 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult
- Obese
- Hyperlipidemic
- Diabetic patients
- Diagnosed with non-alcoholic fatty liver disease and non-alcoholic Steatohepatitis
Key exclusion criteria (6 listed)
- Pregnant women
- Breast feeding women
- Diabetic patients with ketoacidosis
- Hyperlipidemic patients with cardiovascular dysfunction
- Patients with NAFLD or NASH induced hepatocellular carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pioglitazone (PIO)30 mg orally once daily | Drug | Pioglitazone |
| Empagliflozin10 mg orally once daily | Drug | Empagliflozin |
| Statin (Atorvastatin)20 mg orally once daily | Drug | Statins |
| Empagliflozin plus Statin (Atorvastatin)Orally once daily of each (10 mg, 20 mg respectively) | Drug | Empagliflozin plus statins |
| Pioglitazone plus AtorvastatinOrally once daily of each (30mg and 20mg respectively) | Drug | Pioglitazone plus Statins |
Primary outcome
The controlled attenuation parameter (CAP).
Time frame: After 3 months
The CAP value is expressed in dB/m.
The liver stiffness measurement (LSM) using FibroScan®.
Time frame: After 3 months
The LSM value is expressed as kilopascal or kPa.
1 secondary outcome
Fibrosis-4 (FIB-4) index
Time frame: After 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No. Data is available with corresponding author on reasonable request
Related trials for Non-alcoholic Fatty Liver Disease NAFLD
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eman Swan principal investigator
Badr University in Cairo, Faculty of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pioglitazone (PIO), Empagliflozin and Statin (Atorvastatin) in people with Non-alcoholic Fatty Liver Disease NAFLD and Non-alcoholic Steatohepatitis NASH, run by Badr University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman Swan, PHD (+201090111013, eman.said@buc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The controlled attenuation parameter (CAP). (time frame: After 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.