NCT03449446

Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects With Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 395 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are: * To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to NASH * To evaluate changes in liver fibrosis, without worsening of NASH

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	SEL	18 mg tablet administered orally once daily without regard to food
DRUG	FIR	20 mg tablet administered orally once daily without regard to food
DRUG	CILO	30 mg tablet administered orally once daily without regard to food
DRUG	Placebo to match FIR	Tablet administered orally once daily without regard to food
DRUG	Placebo to match CILO	Tablet administered orally once daily without regard to food
DRUG	Placebo to match SEL	Tablet administered orally once daily without regard to food

Timeline

• Start date: 2018-03-21
• Primary completion: 2019-10-30
• Completion: 2019-11-19
• First posted: 2018-02-28
• Last updated: 2020-12-03
• Results posted: 2020-12-03

Locations

101 sites across 6 countries: United States, Australia, Canada, Hong Kong, New Zealand, Puerto Rico

Regulatory

• FDA-regulated drug study