At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 220 enrolled
Drug / intervention
SEL +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Regimens in Subjects With Nonalcoholic Steatohepatitis (NASH)
In Brief
A Phase 2 clinical trial evaluating SEL, FIR, and 3 other interventions for Nonalcoholic Steatohepatitis (NASH) and Nonalcoholic Fatty Liver Disease (NAFLD). Completed, enrolled 220 participants across 13 sites in 2 countries.
Detailed Summary
The primary objective of this study is to evaluate the safety and tolerability of selonsertib, firsocostat, cilofexor, fenofibrate and/or Vascepa® in adults with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNew Zealand, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartJun 2016
Primary CompletionDec 2020
TodayJul 2026
First PostedMay 24, 2016
Enrollment StartJun 13, 2016
Primary CompletionDec 17, 2020
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 10.1 years ago
Interventions
SELdrug
Administered orally once daily
FIRdrug
Administered orally once daily
CILOdrug
Administered orally once daily
FENOdrug
Administered orally once daily
VASdrug
Administered orally two times daily