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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
154
Participants will receive dapagliflozin 10mg po qd
Participants will receive placebo po qd
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Improvement in scored liver histological improvement over 12 months
Time frame: Baseline to 12 months
Resolution of NASH
defined as a hepatocellular ballooning score of 0, and lobular inflammation score of 0 or 1) without worsening of fibrosis
Time frame: Baseline to 12 months
Improvement of fibrosis
defined as reduction in fibrosis of at least 1 stage) without worsening of NASH
Time frame: Baseline to 12 months
Change in fibrosis score
Time frame: Baseline to 12 months
Change in each component score in the NAS
Time frame: Baseline to 12 months
Change in body weight
Time frame: Baseline to 12 months
Change in waist circumference
Time frame: Baseline to 12 months
Change in visceral fat
Time frame: Baseline to 12 months
Change in liver fat
Time frame: Baseline to 12 months
Change in HbA1C
Time frame: Baseline to 12 months
Change in blood pressure
Time frame: Baseline to 12 months
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Change in serum lipids
Time frame: Baseline to 12 months
Change in insulin resistance
Time frame: Baseline to 12 months
Change in inflammatory markers of NASH
Time frame: Baseline to 12 months
Change in health related quality of life scores (SF-36)
Time frame: Baseline to 12 months