NCT02781584

Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)

A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Regimens in Subjects With Nonalcoholic Steatohepatitis (NASH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Nonalcoholic Steatohepatitis (NASH)
• Nonalcoholic Fatty Liver Disease (NAFLD)

Interventions

Type	Name	Description
DRUG	SEL	Administered orally once daily
DRUG	FIR	Administered orally once daily
DRUG	CILO	Administered orally once daily
DRUG	FENO	Administered orally once daily
DRUG	VAS	Administered orally two times daily

Timeline

• Start date: 2016-06-13
• Primary completion: 2020-12-17
• Completion: 2020-12-17
• First posted: 2016-05-24
• Last updated: 2022-03-16
• Results posted: 2022-02-02

Locations

13 sites across 2 countries: United States, New Zealand

Regulatory

• FDA-regulated drug study