Zydus Cadila has initiated a Phase 2 clinical trial for evaluating the effect of Saroglitazar Mg in the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) in women with polycystic ovary syndrome (PCOS). The EVIDENCES VII trial is currently recruiting patients across several clinical sites in the United States of America and Mexico.
Research suggests that in women with polycystic ovary syndrome (PCOS), the risk for Non-Alcoholic Fatty Liver Disease is increased. PCOS affects fertility and also significantly increases metabolic complications.
The trial will evaluate the change in hepatic fat content from baseline following 24 weeks of treatment as measured by MRI-PDFF in patients treated with Saroglitazar Magnesium as compared to placebo as the primary endpoint. The secondary endpoints of the trial also include measurements of liver enzymes, insulin resistance, liver fibrosis, liver stiffness, BMI, waist circumference, MRI-derived measures of total liver fat index, MRI-derived measures of total liver volume, lipid and lipoprotein levels, SHBG level, ovarian function, free androgen index and pharmacokinetic parameters.
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