CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 127 enrolled
Drug / intervention
Firsocostat +1 moredrug
Likely dose
Firsocostat capsules orally once dailyAI-extracted
Key inclusion· 5
  • ✓Clinical diagnosis of NAFLD
  • ✓MRI-PDFF showing ≥8% steatosis OR historical liver biopsy consistent with NASH and non-cirrhotic fibrosis
  • ✓Liver stiffness ≥2.5 kPa on MRE (if imaging-based qualification)
  • ✓Platelet count ≥100,000/mm³
Key exclusion· 7
  • ✕Pregnancy or lactation
  • ✕ALT >5× upper limit of normal
  • ✕Other causes of liver disease: autoimmune, viral, or alcoholic
  • ✕Cirrhosis or prior decompensated liver disease (ascites, hepatic encephalopathy, variceal bleeding)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02856555
NCT02856555Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects With Nonalcoholic Steatohepatitis

Gilead Sciences·interventional·Posted Aug 5, 2016·Updated Jul 24, 2020

In Brief

A Phase 2 clinical trial evaluating Firsocostat and Placebo for Nonalcoholic Steatohepatitis (NASH). Completed, enrolled 127 participants across 36 sites.

Detailed Summary

The primary objective of this study is to evaluate the safety and tolerability of firsocostat in adults with nonalcoholic steatohepatitis (NASH).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNonalcoholic Steatohepatitis (NASH)
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 5, 2016
Enrollment StartAug 8, 2016
Primary CompletionJul 18, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.9 years ago

Interventions

Firsocostatdrug

Capsules orally once daily.

Placebodrug

Placebo matched to firsocostat orally once daily.