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Therapeutic Response of Sodium-glucose Co-transporter Type-2 Inhibitor in Non-diabetic MAFLD Patients: a Pilot Study

Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05782972
Collaborator
(none)
50
Enrollment
1
Arm
26.4
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: dapagliflozin (Forxiga)
 Phase 4

Detailed Description

This is single-arm, prospective study and 50 non-diabetic MAFLD patients are enrolled consecutively at Taipei Tzu Chi Hospital. MAFLD was defined as the presence of fatty liver in imaging or histologic examination plus one of three components including overweight/obese, diabetes mellitus, or metabolic dysfunction. The non-diabetic definition is no previous history of diabetes mellitus and HbA1C < 6.5%. The inclusion criteria were ALT elevation (>35 U/L in male and >25 U/L in female) or FIB-4 >=1.45. They received oral dapagliflozin (Forxiga) 10 mg/day for 24 weeks. Those with cancer history, systolic blood pressure < 100 mmHg, or eGFR < 30 ml/min/1.73m2, or history of urinary tract infection/genital yeast infection were excluded. The primary outcomes are the improvement of liver inflammation marker (serum ALT level)or fibrosis parameters after 24 weeks treatment. The adverse events were also recorded. The severity of liver fibrosis was determined using NAFLD-fibrosis score and ultrasound-based elastography method (ARFI).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
single-arm, prospective studysingle-arm, prospective study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Therapeutic Response of Sodium-glucose Co-transporter Type-2 Inhibitor in Non-diabetic MAFLD Patients: a Pilot Study
Anticipated Study Start Date :
Mar 20, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: dapagliflozin (Forxiga) treatment

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

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

Outcome Measures

Primary Outcome Measures

  1. improvement of liver inflammatory marker [24 weeks]

    the change of ALT between baseline and week 24 after treatment

  2. improvement of liver fibrosis marker [24 weeks]

    the change of NAFLD fibrosis score

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. diabetes history or HbA1C> 6.5

  2. cancer history

  3. systolic blood pressure < 100 mmHg

  4. eGFR < 30 ml/min/1.73m2

  5. history of urinary tract infection/genital yeast infection

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chia-Chi Wang, Professor, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
ClinicalTrials.gov Identifier:
NCT05782972
Other Study ID Numbers:
  • TCRD-TPE-112-11
First Posted:
Mar 24, 2023
Last Update Posted:
Mar 24, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Dapagliflozin

Study Results

No Results Posted as of Mar 24, 2023