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

Inclusion Criteria:

1. Male and female patients aged ≥18 years
2. Patients who have been prescribed Saroglitazar for NAFLD will be included in thisPhase 4 study (patients who use Saroglitazar for the first time)
3. Patients able to and willing to provide written informed consent and comply with therequirements of the study protocol .
4. Patients with a prior documented diagnosis of NAFLD based on the AASLD criteria. NAFLDis defined either by previous histology or clinical imaging in individuals who consumelittle or no alcohol and do not have a cause for secondary hepatic steatosis oranother cause of chronic liver disease. In addition, patients must have one of thefollowing criteria to indicate ongoing NAFLD at screening:
5. Liver stiffness through transient elastography, an LSM ≥8 kPa OR
6. Serum ALT ≥45 U/L

Exclusion Criteria:

1. Consumption of alcohol for at least 90 consecutive days in last one year: >2 units ofalcohol per day (>14 units per week) for males and >1 unit of alcohol per day (>7units per week) for females. Note: 1 unit = 360 mL of beer, or 120 mL of wine, or 30mL 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 liverhistology or imaging.
4. Contraindications to Saroglitazar or any disease conditions affecting the ability toevaluate the effects of Saroglitazar.
5. History or other evidences of severe illness or any other conditions that would makepatient, in the opinion of the investigator, unsuitable for the study.
6. Any previous history of ascites, hepatic encephalopathy, oesophageal varices oradmission/emergency department visit for hepatic decompensation.
7. Women of child bearing potential: inability or unwillingness to practice contraceptionfor the duration of the study.
8. Pregnant or breast feeding females