- Selonsertib monotherapy is not effective for improving disease in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH).
Why this matters
- Additional data are needed to identify the effect of selective inhibitors of apoptosis signal-regulating kinase 1—like selonsertib—for reducing common events associated with NASH.
- Findings were from 2 phase 3 randomized controlled trials (STELLAR-3 and STELLAR-4).
- Patients with NASH and bridging fibrosis or compensated cirrhosis were randomly assigned to once-daily selonsertib 18 mg (n=322), selonsertib 6 mg (n=321), or placebo (n=159) for up to 240 weeks.
- Primary endpoint: proportion of patients with ≥1-stage improvement in fibrosis at week 48.
- Secondary endpoints: changes in noninvasive tests (NITs) of fibrosis and adjudicated cirrhosis-related clinical events.
- Funding: Gilead Sciences.
- In STELLAR-3, selonsertib 18 mg was not superior to placebo for achieving the primary endpoint at 48 weeks (9.3% vs 13.2%; P=.42).
- No difference was observed between selonsertib 6 mg and placebo in the proportion of patients achieving the primary endpoint (12.1% vs 13.2%; P=.93).
- In the STELLAR-4 trial, no difference was found between the 2 selonsertib doses and placebo with regard to the primary endpoint.
- Selonsertib did not significantly effect the liver, NITs of fibrosis, or clinical events (data not reported).
- The study looked at selonsertib as monotherapy only.