Efficacy and Safety of Empagliflozin in patients with Metabolic Associated Steatotic Liver Disease: a randomized controlled trial

To assess the Efficacy and Safety of Empagliflozin in patients with Metabolic Associated Steatotic Liver Disease.

The study was a phase 4, single-center, single-blinded, randomized controlled trial. It enrolled a total of 46 participants.

Conducted at the Department of Medicine and Gastroenterology, Mayo Hospital Lahore. Identical placebo tablets matching empagliflozin 10 mg in size, shape, color, and packaging will be used to maintain blinding integrity. All medications will be dispensed in coded, identical blister packs labeled without revealing treatment allocation. All participants will receive standardized instructions for medication intake and possibility of mild side effects to avoid differentiating between groups and perception bias.

Inclusion criteria: Patients having age between 30-65 years, both male and female, having -MASLD receiving Empagliflozin therapy after giving consent along with standard therapy. Exclusion criteria: Patients having HCV, HBV, those having tumor of liver. Patients that are unable to understand local languages. Non cooperative patients, critical cases (ICU admitted, mechanical ventilation, coma patient, GCS score less than 10) are excluded from the study.

Patients will be randomly administered with empagliflozin 10 mg once daily orally for six months without modifying existing treatment for MASLD. The placebo/control group in the empagliflozin study received standard MASLD therapy along with a daily oral placebo tablet identical in appearance to empagliflozin.

Efficacy of Empagliflozin: Measured by the Fibrosis-4 (FIB-4) Index score, which assesses liver fibrosis progression. Safety of Empagliflozin: Assessed through the SF-36 (Short Form-36 Health Survey), which measures the physical and mental health of the patients.

1. Method of randomization: Simple randomization. 2. Unit of randomization: Individual patient. 3. Randomization strata in stratified randomization: Not applicable (no stratification used). 4. Tools used in randomization: Computer-generated random numbers and sealed opaque envelopes. 5. How the random sequence was built: Using a computer software to generate a random sequence. 6. Whether or not allocation concealment was carried out: Yes, through sealed, sequentially numbered opaque envelopes.

Participant will be blind and blinding will be ensured through a rigorous placebo-controlled design. Identical placebo tablets matching empagliflozin 10 mg in size, shape, color, and packaging will be used to maintain blinding integrity. All medications will be dispensed in coded, identical blister packs labeled without revealing treatment allocation. Participants will receive standardized instructions for medication intake to avoid differentiating between groups. They will also be informed that mild side effects may occur in all participants, regardless of group, to minimize perception bias. Follow-up assessments will be conducted using neutral, standardized language to prevent unblinding.

Deidentified Individual Participant Data (IPD): Includes demographic data (age, sex, socioeconomic status), baseline clinical data (stage of cirrhosis, CLDQ scores), and follow-up outcome data (monthly CLDQ scores for 6 months). Analytic Code: Statistical analysis scripts used to compare outcomes, likely in SPSS or Excel. Study Protocol: Full protocol including objectives, methodology, inclusion/exclusion criteria, interventions, and outcome measures. Consent Form: Template of the informed consent document used in local languages. Data Dictionary: Variable definitions, coding instructions, units, and value ranges. Clinical Study Report (CSR): A structured report summarizing methodology, participant flow, statistical analysis, and results.

All data and documents will become available within 6 months after publication of the main study results in a peer-reviewed journal. They will remain available for a minimum of 5 years after the date of publication. Start date (approx.): January 2026 (assuming publication by mid-2025) End date: January 2031 Extensions may be granted upon request, subject to ethical approval and institutional guidelines.

Data and supporting documents will be shared with qualified researchers, healthcare professionals, and academics affiliated with recognized institutions, including universities, hospitals, and nonprofit research organizations. Access for commercial entities (e.g., pharma/biotech companies) may also be considered on a case-by-case basis, provided the intended use is ethically justified and approved by the principal investigator and institutional ethics committee. All requestors will be required to submit a data use agreement, outlining terms for privacy, data security, and non-commercial use unless explicitly approved.

Access to deidentified IPD and supporting documents will be granted for scientific research purposes only, such as: Secondary analysis to verify study results Meta-analyses or systematic reviews Methodological research or development of new analysis tools Academic research or graduate thesis work Requests must include a brief proposal outlining the research objective, intended use, methodology, and institutional affiliation. All requests will be reviewed by the Principal Investigator (PI) in consultation with the Institutional Ethics Committee. Approval will be based on the scientific merit, ethical soundness, and alignment with patient confidentiality protections.

All data and related documents can be requested from: Contact Person: Dr. Muhammad Umer Sheikh Institution: Department of Gastroenterology, Mayo Hospital, Lahore, Pakistan Email: dr.usheikh@gmail.com The data will be shared electronically through secure channels such as institutional file-sharing platforms or password-protected email attachments.

Initial Contact: Interested researchers should email a formal request to the Principal Investigator with: A brief research proposal Intended use of the data Institutional affiliation Ethical approval or justification (if available) Review Process: The request will be reviewed within 2–4 weeks by the Principal Investigator in collaboration with the institutional ethics committee. Data Use Agreement: If approved, the requester must sign a Data Use Agreement (DUA) that outlines confidentiality, non-commercial use, and data protection obligations. Data Sharing: Once the DUA is signed, data/documents will be sent electronically within 7–10 working days. This process ensures transparency, patient privacy, and ethical data use, while promoting scientific collaboration.