Dapagliflozin Efficacy and Action in NASH

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT03723252
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Participants will receive dapagliflozin 10mg po qd
  • Placebo — DRUG
    Participants will receive placebo po qd

Study Details

This is a multicentre, randomized, placebo-controlled trial to assess the efficacy and safety of dapagliflozin on improving non-alcoholic steatohepatitis as determined by liver biopsies and metabolic risk factors.

Key Dates

Start date
Mar 20, 2019
Status verified
Mar 2024
Primary completion
Mar 22, 2024
Completion
Mar 28, 2024

Study Design

Enrollment
154 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin group
    Participants will receive dapagliflozin 10mg po qd.
  • Placebo Comparator: Placebo group
    Participants will receive placebo po qd.

Primary Outcome Measure

Improvement in scored liver histological improvement over 12 months [ Time Frame: Baseline to 12 months ]

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