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

Sponsor
National Taiwan University Hospital
Study ID
NCT05308160
Phase
PHASE3
Status
Unknown

Conditions

  • Fatty Liver

Eligibility Criteria

Sex
ALL
Age
20 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10Mg Tab — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 28, 2021
Status verified
Jun 2021
Primary completion
Jun 30, 2023
Completion
Apr 30, 2024

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin
    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.
  • Placebo Comparator: Non-used drug
    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 Measure

Safety Outcome Measure [ Time Frame: 6 months ]

Central Contacts

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