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

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zydus Discovery DMCC; Zydus Therapeutics Inc.

Criteria

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.