Diabete Type 2AS-NAFLDNCT07338331
Comparative Effects of Aspirin, Metformin and SGLT2 Inhibitors on Liver Enzymes, Lipid Profile, and FibroScan Findings in Non-Alcoholic Fatty Liver Disease
A study testing Aspirin, Dapagliflozin (10Mg Tab) along with standard medical therapy and Metformin 1000 mg in people with Diabete Type 2 and Non Alcoholic Fatty Liver, run by Galala University at 1 site in Egypt.
Trial summary
Non-alcoholic fatty liver disease (NAFLD), currently referred to as metabolic dysfunction-associated steatotic liver disease (MASLD), is a common hepatic manifestation of metabolic dysfunction and may progress from simple steatosis to steatohepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabete Type 2, Non Alcoholic Fatty Liver
- What is being tested?
- Aspirin, Dapagliflozin (10Mg Tab) along with standard medical therapy and Metformin 1000 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Apr 2023to 19 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Inclusion Criteria: if one or more the following are present:
- Diabetes mellitus, unless receiving only Dapagliflozin for treatment.
- Adult individuals (18-65 years) with a clinical diagnosis of NAFLD based on liver ultrasound
- No history of alcohol consumption or consumption within 3 months.
- Absence of other liver diseases.
- No significant renal or gastrointestinal issues that could interfere with treatment.
Exclusion Criteria:Patients were excluded from our study if one or more the -following are present:
- Pregnancy or breastfeeding.
- Active chronic viral hepatitis or autoimmune liver disease.
- History of gastrointestinal bleeding or other contraindications for Aspirin.
- Severe renal insufficiency.
- Alcohol intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Effect of Aspirin, Metformin, and SGLT2 Inhibitor Intake in Non-Alcoholic Fatty Liver on Liver Enzymes, Lipid Profile, and the Results of FibroScan
Non-alcoholic fatty liver disease (NAFLD), currently referred to as metabolic dysfunction-associated steatotic liver disease (MASLD), is a common hepatic manifestation of metabolic dysfunction and may progress from simple steatosis to steatohepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma.
This randomized clinical trial evaluated and compared three pharmacological approaches with different mechanisms of action: low-dose aspirin as an anti-inflammatory and antiplatelet therapy, dapagliflozin as a sodium-glucose cotransporter-2 (SGLT2) inhibitor with metabolic effects, and metformin as an insulin-sensitizing therapy.
The study assessed their effects on liver enzymes, lipid profile, and FibroScan-derived measures of hepatic steatosis and liver stiffness over a 6-month treatment period.
Read the detailed description
This was a single-center, open-label, parallel-group randomized controlled clinical trial conducted over 6 months in adults diagnosed with non-alcoholic fatty liver disease (NAFLD), currently referred to as metabolic dysfunction-associated steatotic liver disease (MASLD).
Participants were randomly allocated to one of three treatment groups:
- Aspirin group: aspirin 100 mg orally once daily for 6 months.
- Dapagliflozin group: dapagliflozin 10 mg orally once daily for 6 months.
- Metformin group: metformin 1000 mg orally once daily for 6 months.
The study was designed to compare the hepatic and metabolic effects of anti-inflammatory/antiplatelet therapy, SGLT2 inhibition, and insulin-sensitizing therapy in patients with NAFLD/MASLD.
Participants underwent clinical and laboratory assessment at baseline and after 6 months of treatment. Laboratory assessments included liver enzymes, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP), together with lipid-profile parameters, including total cholesterol, triglycerides, and high-density lipoprotein cholesterol (HDL-C).
Hepatic steatosis and liver stiffness were assessed noninvasively using vibration-controlled transient elastography (FibroScan). The controlled attenuation parameter (CAP, dB/m) was used to assess hepatic steatosis, while liver stiffness measurement (LSM, kPa) was used to assess liver stiffness/fibrosis-related changes.
The main study outcomes included changes from baseline to 6 months in FibroScan-derived CAP and LSM values, liver enzymes, and lipid-profile parameters. Additional metabolic and clinical outcomes included body weight, waist circumference, and other relevant metabolic indicators where available.
Statistical Analysis: Continuous variables were summarized using appropriate descriptive statistics. Within-group changes from baseline to 6 months were evaluated using paired statistical tests as appropriate. Comparisons among the three treatment groups were performed using analysis of variance (ANOVA) or corresponding non-parametric tests, as applicable. Analysis of covariance (ANCOVA) adjusting for baseline values was used when baseline differences were present. Appropriate post-hoc pairwise comparisons were performed where required. All statistical tests were two-sided, and a p-value <0.05 was considered statistically significant.
- Conditions
- Diabete Type 2, Non Alcoholic Fatty Liver
- Being tested
- Aspirin, Dapagliflozin (10Mg Tab) along with standard medical therapy, Metformin 1000 mg
- Keywords
- Non-alcoholic fatty liver disease, Aspirin, Dapagliflozin, Liver enzymes, Lipid profile, metformin
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called aspirin protect®
Participants received 100 mg of aspirin (aspirin protect®) as oral daily doses for 6 months.
Dapagliflozin (10Mg Tab) along with standard medical therapyDrug
Also called Diaflozimet ®
Participants received 10 mg of dapagliflozin (Diaflozimet ®) as oral once-daily doses for 6 months.
Metformin 1000 mgDrug
Participants received metformin 1000 mg orally once daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| aspirin group | Experimental | Participants were received 100 mg of aspirin as oral daily doses for 6 months. Receives: Drug: Aspirin |
| Dapagliflozin group | Experimental | Participants were received 10 mg of dapagliflozin as oral once-daily doses for 6 months. Receives: Drug: Dapagliflozin (10Mg Tab) along with standard medical therapy |
| Metformin group | Experimental | Participants received metformin 1000 mg orally once daily for 6 months. Receives: Drug: Metformin 1000 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
lipid profile and Fibroscan results
- Changes in liver enzymes (AST, ALT, ALP, GGT) after 6 months.
- Lipid profile (Total Cholesterol, LDL, HDL, Triglycerides) at baseline and after 6 months.
- Fibroscan results (liver stiffness measurement) at baseline and after 6 months.
Measured: 6 months
lipid profile and Fibroscan evalution
- Changes in liver enzymes (AST, ALT, ALP, GGT) after 6 months.
- Lipid profile (Total Cholesterol, LDL, HDL, Triglycerides) at baseline and after 6 months.
- Fibroscan results (liver stiffness measurement) at baseline and after 6 months.
Measured: 6 months
Secondary outcomes (1)
indicators of metabolic improvement
- Improvement in clinical symptoms (fatigue, discomfort).
- Impact on body weight and waist circumference (as indicators of metabolic improvement).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start4 Apr 2023
- Primary completion5 Apr 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabete Type 2Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Hamed, Galala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338331
- Sponsor's protocol ID
- Galala U
- Acronym
- AS-NAFLD
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamed EM, Hamza E, Al-Dhelaan RA, Alsulami FT, Khallaf AM, Badran AS, Saleh A, Mahmoud AAM. Anti-inflammatory versus metabolic therapy in MASLD: a randomized clinical trial of aspirin and dapagliflozin using fibroscan outcomes. Naunyn Schmiedebergs Arch Pharmacol. 2026 Oct 20. doi: 10.1007/s00210-026-05956-9. Online ahead of print.
PubMed 42900372
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Aspirin, Metformin, and SGLT2 Inhibitor Intake in Non-Alcoholic Fatty Liver on Liver Enzymes, Lipid Profile, and the Results of FibroScan
- ClinicalTrials.gov ID
- NCT07338331
- Acronym / sponsor ID
- AS-NAFLD / Galala U
- Conditions
- Diabete Type 2, Non Alcoholic Fatty Liver
- Keywords
- Non-alcoholic fatty liver disease, Aspirin, Dapagliflozin, Liver enzymes, Lipid profile, metformin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Galala UniversityUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 5 Apr 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 13 Jan 2026 (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.
Non-alcoholic fatty liver disease (NAFLD), currently referred to as metabolic dysfunction-associated steatotic liver disease (MASLD), is a common hepatic manifestation of metabolic dysfunction and may progress from simple steatosis to steatohepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma.
This randomized clinical trial evaluated and compared three pharmacological approaches with different mechanisms of action: low-dose aspirin as an anti-inflammatory and antiplatelet therapy, dapagliflozin as a sodium-glucose cotransporter-2 (SGLT2) inhibitor with metabolic effects, and metformin as an insulin-sensitizing therapy.
The study assessed their effects on liver enzymes, lipid profile, and FibroScan-derived measures of hepatic steatosis and liver stiffness over a 6-month treatment period.
Detailed description
This was a single-center, open-label, parallel-group randomized controlled clinical trial conducted over 6 months in adults diagnosed with non-alcoholic fatty liver disease (NAFLD), currently referred to as metabolic dysfunction-associated steatotic liver disease (MASLD).
Participants were randomly allocated to one of three treatment groups:
- Aspirin group: aspirin 100 mg orally once daily for 6 months.
- Dapagliflozin group: dapagliflozin 10 mg orally once daily for 6 months.
- Metformin group: metformin 1000 mg orally once daily for 6 months.
The study was designed to compare the hepatic and metabolic effects of anti-inflammatory/antiplatelet therapy, SGLT2 inhibition, and insulin-sensitizing therapy in patients with NAFLD/MASLD.
Participants underwent clinical and laboratory assessment at baseline and after 6 months of treatment. Laboratory assessments included liver enzymes, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP), together with lipid-profile parameters, including total cholesterol, triglycerides, and high-density lipoprotein cholesterol (HDL-C).
Hepatic steatosis and liver stiffness were assessed noninvasively using vibration-controlled transient elastography (FibroScan). The controlled attenuation parameter (CAP, dB/m) was used to assess hepatic steatosis, while liver stiffness measurement (LSM, kPa) was used to assess liver stiffness/fibrosis-related changes.
The main study outcomes included changes from baseline to 6 months in FibroScan-derived CAP and LSM values, liver enzymes, and lipid-profile parameters. Additional metabolic and clinical outcomes included body weight, waist circumference, and other relevant metabolic indicators where available.
Statistical Analysis: Continuous variables were summarized using appropriate descriptive statistics. Within-group changes from baseline to 6 months were evaluated using paired statistical tests as appropriate. Comparisons among the three treatment groups were performed using analysis of variance (ANOVA) or corresponding non-parametric tests, as applicable. Analysis of covariance (ANCOVA) adjusting for baseline values was used when baseline differences were present. Appropriate post-hoc pairwise comparisons were performed where required. All statistical tests were two-sided, and a p-value <0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aspirin group | Experimental | Drug: AspirinParticipants were received 100 mg of aspirin as oral daily doses for 6 months. |
| Dapagliflozin group | Experimental | Drug: Dapagliflozin (10Mg Tab) along with standard medical therapyParticipants were received 10 mg of dapagliflozin as oral once-daily doses for 6 months. |
| Metformin group | Experimental | Drug: Metformin 1000 mgParticipants received metformin 1000 mg orally once daily for 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| AspirinAlso: aspirin protect®Participants received 100 mg of aspirin (aspirin protect®) as oral daily doses for 6 months. | Drug | aspirin group |
| Dapagliflozin (10Mg Tab) along with standard medical therapyAlso: Diaflozimet ®Participants received 10 mg of dapagliflozin (Diaflozimet ®) as oral once-daily doses for 6 months. | Drug | Dapagliflozin group |
| Metformin 1000 mgParticipants received metformin 1000 mg orally once daily for 6 months. | Drug | Metformin group |
Primary outcome
lipid profile and Fibroscan results
Time frame: 6 months
* Changes in liver enzymes (AST, ALT, ALP, GGT) after 6 months. * Lipid profile (Total Cholesterol, LDL, HDL, Triglycerides) at baseline and after 6 months. * Fibroscan results (liver stiffness measurement) at baseline and after 6 months.
lipid profile and Fibroscan evalution
Time frame: 6 months
* Changes in liver enzymes (AST, ALT, ALP, GGT) after 6 months. * Lipid profile (Total Cholesterol, LDL, HDL, Triglycerides) at baseline and after 6 months. * Fibroscan results (liver stiffness measurement) at baseline and after 6 months.
1 secondary outcome
indicators of metabolic improvement
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Derived from this study: PubMed 42900372Hamed EM, Hamza E, Al-Dhelaan RA, Alsulami FT, Khallaf AM, Badran AS, Saleh A, Mahmoud AAM. Anti-inflammatory versus metabolic therapy in MASLD: a randomized clinical trial of aspirin and dapagliflozin using fibroscan outcomes. Naunyn Schmiedebergs Arch Pharmacol. 2026 Oct 20. doi: 10.1007/s00210-026-05956-9. Online ahead of print.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin, Dapagliflozin (10Mg Tab) along with standard medical therapy and Metformin 1000 mg in people with Diabete Type 2 and Non Alcoholic Fatty Liver, run by Galala 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?
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: finished, as of the sponsor's last update on 13 Aug 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lipid profile and Fibroscan results (time frame: 6 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?
On the ClinicalTrials.gov record for NCT07338331, which also lists 1 linked publication.
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 13 Aug 2026.