A Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of SNP-610 for the Treatment of Patients With Non-alcoholic Steatohepatitis

Exclusion Criteria

• •1. Decompensated or severe liver disease as evidenced by one or more of the following:
• •1. Confirmed cirrhosis or suspicion of cirrhosis
• •2. Liver transplant
• •3. Liver malignancy
• •4. Ascites
• •5. Bilirubin \>2 x ULN, or ALT or AST \> 10 x ULN
• •6. Acute or chronic hepatitis A, B, C, HIV, or other liver diseases affecting liver function.
• •Patients with cysts, hemangiomas, or similar abnormalities, are accepted.
• •2. History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120-mL wine or 14 cans of 350-mL beer), or other substance abuse within the prior two years
• •3. Subjects who are unable to undergo an MRI scan.
• •4. Subjects have electronically, magnetically and mechanically activated implanted devices, including but not limited to automatic cardioverter defibrillators, cardiac pacemakers, insulin pumps, metallic splinters in the eye, ferromagnetic haemostatic clips in central nervous systems or vascular vessels.
• •5. Significant systemic or major illness other than liver disease, including auto-immune disease, coronary artery disease, cerebrovascular disease, malignant neoplasms, pulmonary disease, renal insufficiency, serious psychiatric disease, and/or other serious disease, that, in the opinion of the Investigator would preclude the subject from participating in and completing the study
• •6. Documented history of serious allergic reaction to SNP-610 or any structurally related compounds
• •7. Diabetic patients who have not maintained a stable dose of oral medication for hyperglycemia or have had more than 10 percent change in their insulin dose over the past two months
• •8. Regular use of agents that are potent against hepatitis or affecting lipid metabolisms, including but not limited to HMGCoA reductase inhibitors (statins), fibrates, silymarin, N-acetylcysteine, or anti-TNF therapies.
• •Note: refer to Section 6.5 Prohibited agents for details.
• •9. Pregnant or lactating
• •10. Female of child-bearing potential who are not committed to take reliable contraception during the participation of the study and at least 4 weeks after the end of the study treatment