Comparative Effects of Aspirin, Metformin and SGLT2 Inhibitors on Liver Enzymes, Lipid Profile, and FibroScan Findings in Non-Alcoholic Fatty Liver Disease

NCT07338331 | Completed DMC

• 1 other identifier: Galala U
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabete Type 2; Non Alcoholic Fatty Liver

Keywords

Non-alcoholic fatty liver disease, Aspirin, Dapagliflozin, Liver enzymes, Lipid profile; metformin

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (1)

• indicators of metabolic improvement

  6 months

Study Arms (3)

aspirin group

EXPERIMENTAL

Participants were received 100 mg of aspirin as oral daily doses for 6 months.

Drug: Aspirin

Dapagliflozin group

EXPERIMENTAL

Participants were received 10 mg of dapagliflozin as oral once-daily doses for 6 months.

Drug: Dapagliflozin (10Mg Tab) along with standard medical therapy

Metformin group

EXPERIMENTAL

Participants received metformin 1000 mg orally once daily for 6 months.

Drug: Metformin 1000 mg

Interventions

Aspirin DRUG

Participants received 100 mg of aspirin (aspirin protect®) as oral daily doses for 6 months.

Also known as: aspirin protect®

aspirin group

Dapagliflozin (10Mg Tab) along with standard medical therapy DRUG

Participants received 10 mg of dapagliflozin (Diaflozimet ®) as oral once-daily doses for 6 months.

Also known as: Diaflozimet ®

Dapagliflozin group

Metformin 1000 mg DRUG

Participants received metformin 1000 mg orally once daily for 6 months.

Metformin group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galala University: lead

Study Sites (1)

Faculty of Pharmacy

Banī Suwayf, Beni Suweif Governorate, 0000, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease

Interventions

Aspirin; dapagliflozin; Tablets; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations; Biguanides; Guanidines; Amidines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 13, 2026
• Study Start: April 4, 2023
• Primary Completion: April 5, 2025
• Study Completion: September 19, 2025
• Last Updated: August 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)