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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-alcoholic Steatohepatitis

In brief

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

Key facts

Study ID

NCT03812029

Run by

Enyo Pharma

People needed

120

Starts

2019-01-30

Expected to finish

2021-07-06

Last updated by the study team

2023-05-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ENYO PHARMA Investigative site 0424 — North Little Rock, Arkansas, United States
• ENYO PHARMA Investigative site 0418 — Lakewood Rch, Florida, United States
• ENYO PHARMA Investigative site 0402 — Ocoee, Florida, United States
• ENYO PHARMA Investigative site 0420 — Orlando, Florida, United States
• ENYO PHARMA Investigative site 0419 — Port Orange, Florida, United States
• ENYO PHARMA Investigative site 0403 — Athens, Georgia, United States
• ENYO PHARMA Investigative site 0423 — Savannah, Georgia, United States
• ENYO PHARMA Investigative site 0407 — Snellville, Georgia, United States
• ENYO PHARMA Investigative site 0409 — Indianapolis, Indiana, United States
• ENYO PHARMA Investigative site 0413 — Baton Rouge, Louisiana, United States
• ENYO PHARMA Investigative site 0404 — Marrero, Louisiana, United States
• ENYO PHARMA Investigative site 0422 — Baltimore, Maryland, United States
• ENYO PHARMA Investigative site 0412 — Jackson, Mississippi, United States
• ENYO PHARMA Investigative site 0414 — Kansas City, Missouri, United States
• ENYO PHARMA Investigative site 0406 — Durham, North Carolina, United States
• ENYO PHARMA Investigative site 0411 — Columbus, Ohio, United States
• ENYO PHARMA Investigative site 0401 — Charleston, South Carolina, United States
• ENYO PHARMA Investigative site 0408 — Charleston, South Carolina, United States
• ENYO PHARMA Investigative site 0421 — Rapid City, South Dakota, United States
• ENYO PHARMA Investigative site 0405 — Arlington, Texas, United States
• ENYO PHARMA Investigative site 0416 — Austin, Texas, United States
• ENYO PHARMA Investigative site 0417 — Edinburg, Texas, United States
• ENYO PHARMA Investigative site 0410 — San Antonio, Texas, United States
• ENYO PHARMA Investigative site 0415 — San Antonio, Texas, United States
• ENYO PHARMA Investigative site 0105 — Brussels, Belgium

Full record on ClinicalTrials.gov

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