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A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis

To evaluate the effect of Saroglitazar Magnesium compared with Placebo on liver scarring in patients with NASH.

There will be 11 in person visits, various procedures will be completed such as a fibroscan, liver biopsy, blood draws and DXA scan. You will be randomly assigned by chance (like the flip of a coin) to receive either Saroglitazar 4 mg or Saroglitazar 2 mg or placebo (inactive substance).

1,325

Yes
 
Jonathan Stine
Nataliya Smith - at stinelaboratory@pennstatehealth.psu.edu or 717-531-0003, ext=320223
Medicine: Gastroenterology and Hepatology (HERSHEY)
 
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05011305
STUDY00020176
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Inclusion Criteria:
Age 18-75
NASH diagnosis
Stage 2 or 3 fibrosis
Exclusion Criteria:
causes of chronic liver disease other than NAFLD
Chronic alcohol or drug abuse
Cirrhosis
Inability to provide informed consent
history of liver transplant
Digestive Systems & Liver Disease
Experimental drug compared to an approved drug
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Location Contacts
Hershey, PA ,