A Single Center, Randomized, Open Label, Parallel Group, Phase 3 Study to Evaluate the Efficacy of Dapagliflozin in Subjects With Nonalcoholic Fatty Liver Disease

Phase 3

• Conditions: Fatty Liver
• Interventions: Drug: Placebo; Drug: Dapagliflozin 10Mg Tab

• Registration Number: NCT05308160
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. This study is supported by Liver Disease Prevention \& Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-28
• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-31
• Last Update Submitted: 2022-03-31
• Study First Posted: 2022-04-01
• Last Update Posted: 2022-04-01
• Primary Completion: 2023-06-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-used drug	Placebo	This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease.
Dapagliflozin	Dapagliflozin 10Mg Tab	This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease.

Primary Outcome Measures

Name	Time	Method
Safety Outcome Measure	6 months	Patients who meet all inclusion criteria and none of the exclusion criteria and are not screen failures for reasons listed above will be randomized in a 1:1 ratio to either receive 10 mg per day dapagliflozin or enter control group at Visit 2.

Trial Locations

Locations (1)

NTUH; 🇨🇳 Taipei City, Zhongzheng Dist., Taiwan