NCT05782972

Brief Summary

The goal of this single arm, prospective study is to test the therapeutic response of oral dapagliflozin (Forxiga) 10 mg/day for 24 weeks in non-diabetic MAFLD patients. The primary outcomes are the improvement of liver inflammation or fibrosis parameters after 24 weeks treatment. The adverse events were also recorded.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

March 11, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

2.7 years

First QC Date

February 19, 2023

Last Update Submit

February 27, 2025

Conditions

Metabolic Associated Fatty Liver Disease

Outcome Measures

Primary Outcomes (2)

  • Change of liver inflammatory marker

    the change of ALT between baseline and week 24 after treatment

    24 weeks

  • Change of liver fibrosis markers between baseline and week 24 after treatment

    The higher NAFLD fibrosis score (NFS), the more severe liver fibrosis (no maximal or minimal levels)

    24 weeks

Study Arms (1)

dapagliflozin (Forxiga) treatment

EXPERIMENTAL

The participants received oral dapagliflozin (Forxiga) 10 mg/day for 24 weeks

Drug: dapagliflozin (Forxiga)

Interventions

dapagliflozin (Forxiga)DRUG

The participants received oral dapagliflozin (Forxiga) 10 mg/day for 24 weeks.

dapagliflozin (Forxiga) treatment

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MAFLD patients (hepatic steatosis plus metabolic dysfunction
  • ALT elevation (\>35 U/L in male and \>25 U/L in female) or FIB-4 \>=1.45

You may not qualify if:

  • diabetes history or HbA1C\> 6.5
  • cancer history
  • systolic blood pressure \< 100 mmHg
  • eGFR \< 30 ml/min/1.73m2
  • history of urinary tract infection/genital yeast infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

New Taipei City, 23142, Taiwan

Location

MeSH Terms

Interventions

dapagliflozin

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single-arm, prospective study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 19, 2023

First Posted

March 24, 2023

Study Start

March 11, 2023

Primary Completion

November 30, 2025

Study Completion

December 31, 2025

Last Updated

March 3, 2025

Record last verified: 2025-02

Locations

TW(1)