1 Study Matches
A Phase 2A, Double-blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Saroglitazar Magnesium 4 mg Tablets for Treating Nonalcoholic Fatty Liver Disease (NAFLD) in Women With Polycystic Ovary Syndrome (PCOS)
The purpose of this study is to evaluate the efficacy and safety of Saroglitazar Magnesium 4 mg Tablets once-daily in women with well characterized Polycystic ovary syndrome (PCOS) diagnosed with nonalcoholic fatty liver disease (NAFLD).
There will be 9 in person visits, various procedures will be completed such as a fibroscan, endometrial biopsy, blood draws and surveys. You will be randomly assigned by chance (like the flip of a coin) to receive either Saroglitazar 4 mg or placebo (inactive substance).
Gloriany Rivas - at firstname.lastname@example.org or 717-531-0003, ext=320223
18 year(s) or older
Inclusion Criteria:Adults age >18-75 years old
Stage 2 or 3 fibrosis
Exclusion Criteria:causes of chronic liver disease other than NAFLD
Inability to provide informed consent
history of liver transplant
Digestive Systems & Liver Disease, Women's Health
Experimental drug compared to a placebo/”sugar pill”