STELLAR 4 (Selonsertib)

Eligibility

Key Inclusion Criteria

  • Liver biopsy consistent with NASH and cirrhosis
  • Meets specific laboratory parameters at the screening visit
  • Males and non-pregnant, non-lactating females between 18-70 years old

Key Exclusion Criteria

  • Prior history of decompensated liver disease
  • Child-Pugh (CP) score >7
  • Model for End-Stage Liver Disease (MELD) score >12

Full Study Name

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (IRB no. 47834)

Summary

This study focuses on patients who have liver cirrhosis as a result of nonalcoholic steatohepatitis (NASH). The study will evaluate an experimental drug called selonsertib for the treatment of advanced fibrosis of the liver due to NASH. NASH is a disease that results when fat accumulates in the liver; the body’s immune system may respond to the fat by attacking liver cells. Selonsertib is being developed to reduce inflammation and fibrosis in the liver. Researchers will assess the effects, safety and tolerability of selonsertib, as well as whether it can reduce fibrosis and associated complications in patients with cirrhosis and fibrosis due to NASH.

Phase

Phase III


Principal Investigator

Mazen Noureddin, MD

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