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NCT03812029 Clinical Trial

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

Non-alcoholic Steatohepatitis Clinical Trial

Official title:
A Phase 2a, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03812029
Other study ID # EYP001-202
Secondary ID 2018-003119-22
Status Completed
Phase Phase 2
First received
Last updated
Start date January 30, 2019
Est. completion date July 6, 2021

Study information
Verified date April 2023
Source Enyo Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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 approximately 50 global clinical sites. Overall, approximately 114 eligible patients will be enrolled: 24 patients in Part A (Safety Run-in Cohort), followed by 90 patients in Part B. In Part A, 24 patients will be randomized on Day 1 to 1 of 4 parallel treatment groups: 100 mg Vonafexor twice daily (BID), 200 mg Vonafexor once daily (QD), 400 mg Vonafexor QD, or placebo BID. In Part B, 90 patients will be randomized on Day 1 to 1 of 3 parallel treatment groups: 100 mg Vonafexor QD, 200 mg Vonafexor QD, or placebo QD.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date July 6, 2021
Est. primary completion date June 16, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 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 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Vonafexor
Oral tablets
Other:
• Placebo
Oral tablets

Locations
Country Name City State
Belgium ENYO PHARMA Investigative site 0105 Brussels
Belgium ENYO PHARMA Investigative site 0101 Edegem
Belgium ENYO PHARMA Investigative site 0103 Gent
Belgium ENYO PHARMA Investigative site 0104 Gent
France ENYO PHARMA Investigative site 0201 Angers
France ENYO PHARMA Investigative site Créteil
France ENYO PHARMA Investigative site 0203 Limoges
France ENYO PHARMA Investigative site 0204 Lyon
France ENYO PHARMA Investigative site 0206 Paris
France ENYO PHARMA Investigative site 0202 Pessac
France ENYO PHARMA Investigative site 0207 Toulouse
France ENYO PHARMA Investigative site 0205 Villejuif
Puerto Rico ENYO PHARMA Investigative site 0429 San Juan
United Kingdom ENYO PHARMA Investigative site 0304 Belfast
United Kingdom ENYO PHARMA Investigative site 0302 Cambridge
United Kingdom ENYO PHARMA Investigative site 0303 London
United Kingdom ENYO PHARMA Investigative site 0305 London
United Kingdom ENYO PHARMA Investigative site 0301 Nottingham
United States ENYO PHARMA Investigative site 0405 Arlington Texas
United States ENYO PHARMA Investigative site 0403 Athens Georgia
United States ENYO PHARMA Investigative site 0416 Austin Texas
United States ENYO PHARMA Investigative site 0422 Baltimore Maryland
United States ENYO PHARMA Investigative site 0413 Baton Rouge Louisiana
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 0411 Columbus Ohio
United States ENYO PHARMA Investigative site 0406 Durham North Carolina
United States ENYO PHARMA Investigative site 0417 Edinburg Texas
United States ENYO PHARMA Investigative site 0409 Indianapolis Indiana
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 0418 Lakewood Ranch Florida
United States ENYO PHARMA Investigative site 0404 Marrero Louisiana
United States ENYO PHARMA Investigative site 0424 North Little Rock Arkansas
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 0421 Rapid City South Dakota
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 0423 Savannah Georgia
United States ENYO PHARMA Investigative site 0407 Snellville Georgia

Sponsors (1)
Lead Sponsor Collaborator
Enyo Pharma

Countries where clinical trial is conducted

United States,  Belgium,  France,  Puerto Rico,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Analysis of Absolute Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level. 12 weeks
Secondary Analysis of Change From Baseline in Glomerular Filtration rate_Part B 12 weeks
Secondary Analysis of Percent Change (Relative) From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level. 12 weeks
Secondary Analysis of Change From Baseline in Corrected T1 (CT1) 12 weeks
Secondary Analysis of Change From Baseline in Alanine Aminotransferase (ALT) 12 weeks
Secondary Analysis of Change From Baseline in Gamma Glutamyltranspeptidase (GT) 12 weeks
Secondary Analysis of Change From Baseline in Body Weight 12 weeks
Secondary Analysis of Change From Baseline in Waist Circumference 12 weeks
Secondary Analysis of Change From Baseline in Waist to Hip ratio_Part B 12 weeks
Secondary Analysis of Change From Baseline in Glomerular Filtration rate_Part A For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group. 12 weeks
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