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A Phase 2A, Double-blind, Randomized, Placebo-ControlledClinical Trial to Evaluate the Efficacy and Safety ofSaroglitazar Magnesium 4 mg Tablets for Treating NonalcoholicFatty Liver Disease (NAFLD) in Women WithPolycystic 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).

Yes
 

Jonathan Stine
Gloriany Rivas - at grivas@pennstatehealth.psu.edu or 717-531-0003, ext=320223
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03617263
STUDY00020411
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Inclusion Criteria:
Adults age >18-75 years old
NAFLD diagnosis
Stage 2 or 3 fibrosis

Exclusion Criteria:
causes of chronic liver disease other than NAFLD
pregnancy
Cirrhosis
Inability to provide informed consent
history of liver transplant
Digestive Systems & Liver Disease, Women's Health
Experimental drug compared to a placebo/”sugar pill”
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Location Contacts
Hershey, PA ,