Saroglitazar Magnesium 4 Mg in the Treatment of NAFLD in Women with PCOS (EVIDENCES VII)

Inclusion Criteria:

• Females, 18 to 45 years of age.

• Previously confirmed diagnosis of PCOS:

1. oligo-and/or anovulation;

2. hyperandrogenism (clinical and/or biochemical);

3. polycystic ovary morphology on ultrasonography

• Evidence of NAFLD within 6 months prior to the Screening Visit (Visit 1).

• Alanine transaminase ≥ 38 U/L at Visit 1. Visit 2 ALT must not increase >30% fromVisit 1.

• Hepatic fat fraction ≥10% by MRI-PDFF.

• Willingness to participate in the study.

• Ability to understand and give informed consent for participation.

• Woman who agrees to use the contraceptive methods.

Exclusion Criteria:

• Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis,cholestatic liver disease, Wilsons disease, hemochromatosis, etc.).

• Average alcohol consumption ≥ 7 drinks per week for women in the 6 months prior toenrollment.

• Clinical, imaging, or histological evidence of cirrhosis.

• Patients who have used medications known to cause hepatic steatosis for more than 2weeks in the past year.

• Prior bariatric surgery.

• Weight loss of more than 5% in the 3 months preceding screening.

• Severe co-morbidities (e.g., advanced cardiac, renal, pulmonary, or psychiatricillness).

• Known allergy, sensitivity or intolerance to Saroglitazar Magnesium, comparator orformulation ingredients.

• Use of antidiabetic and lipid lowering medications if the dose is not stable for atleast the 3 months preceding screening.

• Intake of Vitamin E (>100 IU/day) or multivitamins containing Vitamin E (>100IU/day) 3 months before enrollment.

• Use of drugs with potential effect on NAFLD/NASH in the 3 months prior to screening.

• Illicit substance abuse within the past 12 months.

• Pregnant or breast feeding females.

• Women with known Cushing syndrome or hyperprolactinemia.

• Refusal or inability to comply with the requirements of the protocol, for anyreason, including scheduled clinic visits and laboratory tests.

• History of myopathies or evidence of active muscle diseases.

• History or current significant cardiovascular disease.

• History of malignancy.

• History of bladder disease.