A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities

Exclusion Criteria

• •1. Consumption of alcohol for at least 90 consecutive days in last one year: \>2 units of alcohol per day (\>14 units per week) for males and \>1 unit of alcohol per day (\>7 units per week) for females. Note: 1 unit = 360 mL of beer, or 120 mL of wine, or 30 mL of spirits/hard liquor
• •2. History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis.
• •3. Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging.
• •4. Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar.
• •5. History or other evidences of severe illness or any other conditions that would make patient, in the opinion of the investigator, unsuitable for the study.
• •6. Any previous history of ascites, hepatic encephalopathy, oesophageal varices or admission/emergency department visit for hepatic decompensation.
• •7. Women of child bearing potential: inability or unwillingness to practice contraception for the duration of the study.
• •8. Pregnant or breast feeding females