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

NCT ID: NCT03812029

Last Updated: 2023-05-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-30

Study Completion Date

2021-07-06

Brief Summary

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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

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A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis

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A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH

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Detailed Description

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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.

Conditions

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Non-alcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Triple (Participant, Care Provider, Investigator)

Study Groups

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Vonafexor 100 mg BID

Oral dose twice daily for 12 weeks (84 days)

Group Type EXPERIMENTAL

Vonafexor

Intervention Type DRUG

Oral tablets

Vonafexor 200 mg QD

Oral dose once daily for 12 weeks (84 days)

Group Type EXPERIMENTAL

Vonafexor

Intervention Type DRUG

Oral tablets

Vonafexor 400 mg QD

Oral dose once daily for 12 weeks (84 days)

Group Type EXPERIMENTAL

Vonafexor

Intervention Type DRUG

Oral tablets

Placebo

Oral dose twice daily for 12 weeks (84 days)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral tablets

Vonafexor 100 mg QD

Oral dose once daily for 12 weeks (84 days)

Group Type EXPERIMENTAL

Vonafexor

Intervention Type DRUG

Oral tablets

Interventions

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Vonafexor

Oral tablets

Intervention Type DRUG

Placebo

Oral tablets

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Enyo Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harrison Stephen, MD

Role: PRINCIPAL_INVESTIGATOR

Pinnacle Clinical Research

Locations

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ENYO PHARMA Investigative site 0424

North Little Rock, Arkansas, United States

Site Status

ENYO PHARMA Investigative site 0418

Lakewood Rch, Florida, United States

Site Status

ENYO PHARMA Investigative site 0402

Ocoee, Florida, United States

Site Status

ENYO PHARMA Investigative site 0420

Orlando, Florida, United States

Site Status

ENYO PHARMA Investigative site 0419

Port Orange, Florida, United States

Site Status

ENYO PHARMA Investigative site 0403

Athens, Georgia, United States

Site Status

ENYO PHARMA Investigative site 0423

Savannah, Georgia, United States

Site Status

ENYO PHARMA Investigative site 0407

Snellville, Georgia, United States

Site Status

ENYO PHARMA Investigative site 0409

Indianapolis, Indiana, United States

Site Status

ENYO PHARMA Investigative site 0413

Baton Rouge, Louisiana, United States

Site Status

ENYO PHARMA Investigative site 0404

Marrero, Louisiana, United States

Site Status

ENYO PHARMA Investigative site 0422

Baltimore, Maryland, United States

Site Status

ENYO PHARMA Investigative site 0412

Jackson, Mississippi, United States

Site Status

ENYO PHARMA Investigative site 0414

Kansas City, Missouri, United States

Site Status

ENYO PHARMA Investigative site 0406

Durham, North Carolina, United States

Site Status

ENYO PHARMA Investigative site 0411

Columbus, Ohio, United States

Site Status

ENYO PHARMA Investigative site 0401

Charleston, South Carolina, United States

Site Status

ENYO PHARMA Investigative site 0408

Charleston, South Carolina, United States

Site Status

ENYO PHARMA Investigative site 0421

Rapid City, South Dakota, United States

Site Status

ENYO PHARMA Investigative site 0405

Arlington, Texas, United States

Site Status

ENYO PHARMA Investigative site 0416

Austin, Texas, United States

Site Status

ENYO PHARMA Investigative site 0417

Edinburg, Texas, United States

Site Status

ENYO PHARMA Investigative site 0410

San Antonio, Texas, United States

Site Status

ENYO PHARMA Investigative site 0415

San Antonio, Texas, United States

Site Status

ENYO PHARMA Investigative site 0105

Brussels, , Belgium

Site Status

ENYO PHARMA Investigative site 0101

Edegem, , Belgium

Site Status

ENYO PHARMA Investigative site 0104

Ghent, , Belgium

Site Status

ENYO PHARMA Investigative site 0103

Ghent, , Belgium

Site Status

ENYO PHARMA Investigative site 0201

Angers, , France

Site Status

ENYO PHARMA Investigative site

Créteil, , France

Site Status

ENYO PHARMA Investigative site 0203

Limoges, , France

Site Status

ENYO PHARMA Investigative site 0204

Lyon, , France

Site Status

ENYO PHARMA Investigative site 0206

Paris, , France

Site Status

ENYO PHARMA Investigative site 0202

Pessac, , France

Site Status

ENYO PHARMA Investigative site 0207

Toulouse, , France

Site Status

ENYO PHARMA Investigative site 0205

Villejuif, , France

Site Status

ENYO PHARMA Investigative site 0429

San Juan, , Puerto Rico

Site Status

ENYO PHARMA Investigative site 0304

Belfast, , United Kingdom

Site Status

ENYO PHARMA Investigative site 0302

Cambridge, , United Kingdom

Site Status

ENYO PHARMA Investigative site 0303

London, , United Kingdom

Site Status

ENYO PHARMA Investigative site 0305

London, , United Kingdom

Site Status

ENYO PHARMA Investigative site 0301

Nottingham, , United Kingdom

Site Status

Countries

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United States Belgium France Puerto Rico United Kingdom

References

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Ratziu V, Harrison SA, Loustaud-Ratti V, Bureau C, Lawitz E, Abdelmalek M, Alkhouri N, Francque S, Girma H, Darteil R, Couchoux H, Wolf M, Sanyal A, Vonderscher J, Scalfaro P. Hepatic and renal improvements with FXR agonist vonafexor in individuals with suspected fibrotic NASH. J Hepatol. 2023 Mar;78(3):479-492. doi: 10.1016/j.jhep.2022.10.023. Epub 2022 Nov 9.

Reference Type DERIVED
PMID: 36334688 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2018-003119-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EYP001-202

Identifier Type: -

Identifier Source: org_study_id

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