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Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH)

NCT03812029 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-05-06

Study results available
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Summary

The purpose of this study is to assess the effects of EYP001a (Vonafexor) with respect to safety, tolerability, pharmacokinetics and on markers of liver inflammation in patients with NASH

Conditions

  • Non-alcoholic Steatohepatitis

Interventions

DRUG

Vonafexor

Oral tablets

OTHER

Placebo

Oral tablets

Sponsors & Collaborators

  • Enyo Pharma

    lead INDUSTRY

Principal Investigators

  • Harrison Stephen, MD · Pinnacle Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2021-06-16
Completion
2021-07-06
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Puerto Rico
  • United Kingdom

Study Locations

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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 NCT03812029 on ClinicalTrials.gov