The primary objective of the study is to compare the changes in serum ALT level among patients with non-alcoholic steatohepatitis (NASH) following 3-month treatment of 800 mg SNP-610 or the placebo. The secondary objectives will be to compare the changes in liver fat fraction, other liver function tests, cytokeratin-18 (CK-18) fragment level and adverse event / serious adverse event rates among the interventional and placebo arms.
Age ≥ 20 years
Body weight ≥ 54 kg
Diagnosis of non-alcoholic steatohepatitis (NASH) as evidenced by imaging or other diagnostic assessments. Subject should have documented liver fat content ≥ 10.0 % as measured by MRI method prior to study drug administration.
Alanine aminotransferase (ALT) levels ≥ 2.0x upper limit of normal (ULN) on at least two occasions, seven or more days apart, prior to study drug administration
Confirmed cirrhosis or suspicion of cirrhosis
Liver transplant
Liver malignancy
Ascites
Parallel
SNP-610
DrugSubjects will take 2 tablets once a day orally for 12 weeks
Placebo Oral Tablet
DrugSubjects will take 2 tablets once a day orally for 12 weeks
Alanine aminotransferase
Absolute change from baseline in serum alanine aminotransferase (ALT/GPT)
MRI liver FF
Absolute change from baseline in liver fat content
MRI liver FF
Relative change from baseline in liver fat content
Aspartate aminotransferase
Change in serum level at 12 weeks
Alkaline phosphatase
Change in serum level at 12 weeks
Insulin resistance
Change in insulin resistance at Week 12
Triglycerides
Changes in serum at Week 12
Low density lipoprotein
Changes in serum at Week 12
Total cholesterol
Changes in serum at Week 12
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