The main objective of this study is to evaluate safety and efficacy of ALS-L1023 in patients with Non-alcoholic steatohepatitis
Besides the main objectives, there are other objectives as follows: 1. To evaluate efficacy of ALS-L1023 for liver fibrosis and steatosis by noninvasive imaging biomarker MRI-PDFF and MRE 2. To determine optimized dose of ALS-L1023 in NASH disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Hanyang University Seoul Hospital
Seoul, South Korea
Change in liver fat percentage measured by MRI-PDFF
Liver fat is measured by MRI-PDFF
Time frame: baseline, 24 weeks
Change in liver fibrosis measured by MRE
Liver fibrosis is measured by Magnetic Resonance Enterography
Time frame: baseline, 24 weeks
Change in visceral fat area measured by MRI
Visceral fat area is measured by MRI
Time frame: baseline, 24weeks
Changes in serum concentrations of ALT and AST
ALT and AST concentrations in serum are measured
Time frame: baseline, 24weeks
Change in serum concentration of Pro-C3
Pro-C3 concentration in serum is measured
Time frame: baseline, 24weeks
Change in serum concentration of CK-18
CK-18 concentration in serum is measured
Time frame: baseline, 24weeks
Change in insulin sensitivity determined by HOMA-IR
Insulin sensitivity is determined by Homeostatic Model Assessment for Insulin Resistance
Time frame: baseline, 24weeks
Change in serum concentration of Leptin
Concentration of Leptin in serum is measured
Time frame: baseline, 24weeks
Changes in serum concentrations of ALT and AST
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ALT and AST concentrations in serum are measured
Time frame: baseline, 8weeks, 16weeks
Changes in serum concentrations of TG and TC
Triglyceride and Total Cholesterol concentrations in serum are measured
Time frame: baseline, 8weeks, 16weeks, 24weeks
Change of NAFLD fibrosis score(NFS)
NFS is measured
Time frame: baseline, 8weeks, 16weeks, 24weeks
Change in serum concentration of Ghrelin
Concentration of Ghrelin in serum is measured
Time frame: baseline, 24weeks
Change in serum concentration of Adiponection
Concentration of Adiponection in serum is measured
Time frame: baseline, 24weeks