STELLAR 3 (Selonsertib)

Eligibility

Key Inclusion Criteria

  • Liver biopsy consistent with NASH and bridging (F3 fibrosis)
  • Meets specific laboratory parameters at the screening visit

Key Exclusion Criteria

  • Prior history of decompensated liver disease
  • Child-Pugh (CP) score >6
  • 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 Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis (IRB no. 47832)

Summary

This study focuses on patients who have advanced liver fibrosis without cirrhosis as a result of nonalcoholic steatohepatitis (NASH). The study will test an experimental drug called selonsertib for the treatment of advanced liver fibrosis due to NASH. NASH is a disease that results when fat accumulates in the liver; the body’s immune system may respond by attacking the 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

Contact