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 suffering with polycystic ovary syndrome (PCOS).
The EVIDENCES VII trial is currently recruiting patients across several clinical sites in USA and Mexico.
Research suggests that in women with PCOS, the risk for NAFLD has increased. PCOS affects fertility and also significantly increases metabolic complications. Factors like obesity or insulin resistance can lead to PCOS which can affect liver functioning and lead to NAFLD.
There is a high prevalence of PCOS in the general population affecting 1 in 10 women of childbearing age, causing infrequent or prolonged menstrual periods or excess male hormone (androgen) levels.
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.
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.
There are currently no treatments approved by the US Food and Drug Administration (USFDA) for treatment of NAFLD.