Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH)
Lead Sponsor:
Enyo Pharma
Conditions:
Non-alcoholic Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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
Detailed Description
This is a 2-part, randomized, double-blind, multicenter, placebo-controlled study to evaluate the safety and efficacy of Vonafexor in patients with NASH who likely have stage F2 to F3 fibrosis at appr...
Eligibility Criteria
Inclusion
- Written informed consent
- Suspected diagnosis of NASH, evidenced by elevated alanine aminotransferase (ALT), liver stiffness compatible with F2 or F3 fibrosis and Liver Fat Content (LFC) ≥10% as measured by MRI
- Women of childbearing potential and male patients with female partners must agree to use a dual method of contraception
Exclusion
- Evidence of worsening liver injury
- Previous diagnosis of other forms of non-NASH liver disease
- Use of Vitamin E, glitazones, glucagon-like Peptide-1 receptor agonists, ursodeoxycholic acid, or obeticholic acid within 90 days prior to screening
- History of cirrhosis or liver decompensation
- Known history of alcohol abuse or daily heavy alcohol consumption
- Pregnant or breastfeeding women
- Type 1 diabetes mellitus and uncontrolled type 2 diabetes mellitus
- Patients with contraindications to MRI imaging
Key Trial Info
Start Date :
January 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03812029
Start Date
January 30 2019
End Date
July 6 2021
Last Update
May 6 2023
Active Locations (42)
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1
ENYO PHARMA Investigative site 0424
North Little Rock, Arkansas, United States, 72117
2
ENYO PHARMA Investigative site 0418
Lakewood Rch, Florida, United States, 34211
3
ENYO PHARMA Investigative site 0402
Ocoee, Florida, United States, 34761
4
ENYO PHARMA Investigative site 0420
Orlando, Florida, United States, 32806