Saroglitazar Magnesium 4 mg in the Treatment of NAFLD in Women With PCOS (EVIDENCES VII)

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease in Women With PCOS focused on measuring NAFLD, PCOS, Saroglitazar Magnesium Read More

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% from Visit 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 to enrollment.
• Clinical, imaging, or histological evidence of cirrhosis.
• Patients who have used medications known to cause hepatic steatosis for more than 2 weeks 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 psychiatric illness).
• Known allergy, sensitivity or intolerance to Saroglitazar Magnesium, comparator or formulation ingredients.
• Use of antidiabetic and lipid lowering medications if the dose is not stable for at least the 3 months preceding screening.
• Intake of Vitamin E (>100 IU/day) or multivitamins containing Vitamin E (>100 IU/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 any reason, 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.