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

Trial details

Who runs it

Zydus Therapeutics Inc.

Trial code

NCT03617263

Record updated

2025. december 18.

Original description

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.Read full original descriptionShow less

Phase 2A, Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Saroglitazar Mg 4 mg Tablet Vs Placebo for Treating Nonalcoholic Fatty Liver Disease (NAFLD) in Women With Polycystic Ovary Syndrome (PCOS)

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.

Inclusion: Females, 18 to 45 years of age; Previously confirmed diagnosis of PCOS:; oligo-and/or anovulation; hyperandrogenism (clinical and/or biochemical); 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: Average alcohol consumption ≥ 7 drinks per week for women in the 6 months prior to enrollment; Patients who have used medications known to cause hepatic steatosis for more than 2 weeks in the past year; Prior bariatric surgery; 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; Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilsons disease, hemochromatosis, etc.); Severe co-morbidities (e.g., advanced cardiac, renal, pulmonary, or psychiatric illness); Women with known Cushing syndrome or hyperprolactinemia; History of myopathies or evidence of active muscle diseases; History or current significant cardiovascular disease; History of malignancy; History of bladder disease; Known allergy, sensitivity or intolerance to Saroglitazar Magnesium, comparator or formulation ingredients; Refusal or inability to comply with the requirements of the protocol, for any reason, including scheduled clinic visits and laboratory tests; Clinical, imaging, or histological evidence of cirrhosis; Weight loss of more than 5% in the 3 months preceding screening; Illicit substance abuse within the past 12 months; Pregnant or breast feeding females.

ClinicalTrials.gov NCT03617263