At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 72 enrolled
Drug / intervention
SEL +1 moredrug
Likely dose
SIM 125 mgfrom 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 Phase 2, Randomized, Open Label Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Subjects With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
In Brief
A Phase 2 clinical trial evaluating SEL and SIM for Non-Alcoholic Steatohepatitis (NASH). Completed, enrolled 72 participants across 28 sites in 2 countries.
Detailed Summary
The primary objective of this study is to evaluate the safety and tolerability of GS-4997 (selonsertib \[SEL\]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic steatohepatitis (NASH) and fibrosis stages F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Alcoholic Steatohepatitis (NASH)
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
First PostedJun 2015
Primary CompletionOct 2016
TodayJul 2026
First PostedJun 9, 2015
Enrollment StartJun 8, 2015
Primary CompletionOct 11, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.1 years ago
Interventions
SELdrug
SEL tablet administered orally once daily
SIMbiological
Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly