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

April 13, 2023 updated by: Enyo Pharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • ENYO PHARMA Investigative site 0105
      • Edegem, Belgium, 2650
        • ENYO PHARMA Investigative site 0101
      • Gent, Belgium, 3000
        • ENYO PHARMA Investigative site 0104
      • Gent, Belgium, 9000
        • ENYO PHARMA Investigative site 0103
  • France
      • Angers, France, 49933
        • ENYO PHARMA Investigative site 0201
      • Créteil, France, 94010
        • ENYO PHARMA Investigative site
      • Limoges, France, 87000
        • ENYO PHARMA Investigative site 0203
      • Lyon, France, 69004
        • ENYO PHARMA Investigative site 0204
      • Paris, France, 75013
        • ENYO PHARMA Investigative site 0206
      • Pessac, France, 33600
        • ENYO PHARMA Investigative site 0202
      • Toulouse, France, 31059
        • ENYO PHARMA Investigative site 0207
      • Villejuif, France, 94800
        • ENYO PHARMA Investigative site 0205
  • Puerto Rico
      • San Juan, Puerto Rico
        • ENYO PHARMA Investigative site 0429
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • ENYO PHARMA Investigative site 0304
      • Cambridge, United Kingdom, CB2 0QQ
        • ENYO PHARMA Investigative site 0302
      • London, United Kingdom, E1 1BB
        • ENYO PHARMA Investigative site 0303
      • London, United Kingdom, SE5 9RS
        • ENYO PHARMA Investigative site 0305
      • Nottingham, United Kingdom, NG7 2UH
        • ENYO PHARMA Investigative site 0301
  • United States
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • ENYO PHARMA Investigative site 0424
    • Florida
      • Lakewood Ranch, Florida, United States, 34211
        • ENYO PHARMA Investigative site 0418
      • Ocoee, Florida, United States, 34761
        • ENYO PHARMA Investigative site 0402
      • Orlando, Florida, United States, 32806
        • ENYO PHARMA Investigative site 0420
      • Port Orange, Florida, United States, 32127
        • ENYO PHARMA Investigative site 0419
    • Georgia
      • Athens, Georgia, United States, 30607
        • ENYO PHARMA Investigative site 0403
      • Savannah, Georgia, United States, 31406
        • ENYO PHARMA Investigative site 0423
      • Snellville, Georgia, United States, 30078
        • ENYO PHARMA Investigative site 0407
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • ENYO PHARMA Investigative site 0409
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • ENYO PHARMA Investigative site 0413
      • Marrero, Louisiana, United States, 70072
        • ENYO PHARMA Investigative site 0404
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • ENYO PHARMA Investigative site 0422
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • ENYO PHARMA Investigative site 0412
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • ENYO PHARMA Investigative site 0414
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • ENYO PHARMA Investigative site 0406
    • Ohio
      • Columbus, Ohio, United States, 43213
        • ENYO PHARMA Investigative site 0411
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • ENYO PHARMA Investigative site 0401
      • Charleston, South Carolina, United States, 29407
        • ENYO PHARMA Investigative site 0408
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • ENYO PHARMA Investigative site 0421
    • Texas
      • Arlington, Texas, United States, 76012
        • ENYO PHARMA Investigative site 0405
      • Austin, Texas, United States, 78746
        • ENYO PHARMA Investigative site 0416
      • Edinburg, Texas, United States, 78539
        • ENYO PHARMA Investigative site 0417
      • San Antonio, Texas, United States, 78215
        • ENYO PHARMA Investigative site 0410
      • San Antonio, Texas, United States, 78229
        • ENYO PHARMA Investigative site 0415

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vonafexor 100 mg BID
Oral dose twice daily for 12 weeks (84 days)
Drug: Vonafexor
Oral tablets
Experimental: Vonafexor 200 mg QD
Oral dose once daily for 12 weeks (84 days)
Drug: Vonafexor
Oral tablets
Experimental: Vonafexor 400 mg QD
Oral dose once daily for 12 weeks (84 days)
Drug: Vonafexor
Oral tablets
Placebo Comparator: Placebo
Oral dose twice daily for 12 weeks (84 days)
Other: Placebo
Oral tablets
Experimental: Vonafexor 100 mg QD
Oral dose once daily for 12 weeks (84 days)
Drug: Vonafexor
Oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of Change From Baseline in Glomerular Filtration rate_Part B
Time Frame: 12 weeks
12 weeks
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)
Time Frame: 12 weeks
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
Analysis of Change From Baseline in Corrected T1 (CT1)
Time Frame: 12 weeks
12 weeks
Analysis of Change From Baseline in Alanine Aminotransferase (ALT)
Time Frame: 12 weeks
12 weeks
Analysis of Change From Baseline in Gamma Glutamyltranspeptidase (GT)
Time Frame: 12 weeks
12 weeks
Analysis of Change From Baseline in Body Weight
Time Frame: 12 weeks
12 weeks
Analysis of Change From Baseline in Waist Circumference
Time Frame: 12 weeks
12 weeks
Analysis of Change From Baseline in Waist to Hip ratio_Part B
Time Frame: 12 weeks
12 weeks
Analysis of Change From Baseline in Glomerular Filtration rate_Part A
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enyo Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2019

Primary Completion (Actual)

June 16, 2021

Study Completion (Actual)

July 6, 2021

Study Registration Dates

First Submitted

January 17, 2019

First Submitted That Met QC Criteria

January 18, 2019

First Posted (Actual)

January 22, 2019

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

April 13, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYP001-202
  • 2018-003119-22 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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