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

• Status: Completed
• Trial end date: 2021-07-06
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Enyo Pharma

Criteria

Inclusion Criteria:

• Written informed consent

• Suspected diagnosis of NASH, evidenced by elevated alanine aminotransferase (ALT), liver stiffness compatible with F2 or F3 fibrosis and 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 Criteria:

• 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