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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)

NCT03449446 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2020-12-03

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-21
Primary Completion
2019-10-30
Completion
2019-11-19
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Hong Kong
  • New Zealand
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03449446 on ClinicalTrials.gov