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Efficacy and Safety of Empagliflozin in patients with fatty liver

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250430065534N2
Enrollment
78
Registered
2025-05-13
Start date
2025-06-06
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MASLD/Metabolic Associated Steatotic Liver Disease. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Intervention group: Patients who will be randomly administered with empagliflozin 10 mg once daily orally for six months without modifying existing treatment for MASLD. Intervention 2:

Sponsors

King Edward Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients having age between 30-65 years Both male and female Patients having -MASLD receiving Empagliflozin therapy after giving consent, along with standard therapy

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Change in liver fibrosis as measured by the FIB-4 Index. Timepoint: After completion of 6 months of treatment. Method of measurement: Pre- and post-intervention FIB-4 scores were used to assess the efficacy of empagliflozin.

Secondary

MeasureTime frame
Safety and health-related quality of life as measured by the SF-36 Health Survey. Timepoint: After completion of 6 months of treatment. Method of measurement: SF-36 was used to assess both physical and mental health status of participants.

Countries

Pakistan

Contacts

Public ContactDr. Muhammad Umer Sheikh

King Edward Medical University

dr.usheikh@gmail.com+92 321 9994005

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026