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

NCT02781584 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2022-03-16

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-13
Primary Completion
2020-12-17
Completion
2020-12-17
FDA Drug
Yes

Countries

  • United States
  • New Zealand

Study Locations

More Related Trials

Entities

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 NCT02781584 on ClinicalTrials.gov