SARO Study (Saroglitazar Magnesium)

Condition: Nonalcoholic fatty liver disease and/or nonalcoholic steatohepatitis

Eligibility

Key Inclusion Criteria

  • 18-75 years old
  • Body mass index ≥25 kg/m2
  • Diagnosis of NAFLD within 24 months before Visit 1 of the study

Key Exclusion Criteria

  • Consumption of >3 units of alcohol per day if male and >2 units of alcohol per day if female for at least 3 consecutive months in the 5 years before Visit 1 of the study
  • Presence of alternative causes of fatty liver

Full Study Name

A Phase II, Prospective, Multicenter, Double-Blind, Randomized Study of Saroglitazar Magnesium 1 mg, 2 mg or 4 mg Versus Placebo in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis (IRB no. 47307)

Summary

This study focuses on patients who have advanced nonalcoholic fatty liver disease and/or nonalcoholic steatohepatitis (NAFLD/NASH). The purpose of the study is to evaluate the investigational use of a drug called saroglitazar magnesium for the treatment of NAFLD/NASH. Researchers aim to learn the effects of saroglitazar on these patients and will test three doses of the drug to determine which is best tolerated and most effective to use. Participants will be randomly assigned to receive one of three doses or placebo (inactive substance).

NAFLD is the most common form of chronic liver disease. It could be a milder condition such as fatty liver or a more severe condition (NASH). With NASH, the liver cell becomes damaged, and there is a risk of progression to fibrosis and ultimately, cirrhosis.

Phase

Phase II

Principal Investigator

Mazen Noureddin, MD

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