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

NCT03812029 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: EYP001-2022018-003119-22
• Study Type: interventional
• Target: 120
• Locations: 5 countries
• Sites: 42

Brief 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

Conditions

Non-alcoholic Steatohepatitis

Keywords

EYP001 (vonafexor); Liver Diseases; Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; NASH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Analysis of Change From Baseline in Glomerular Filtration rate_Part B

  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)

  12 weeks

• Analysis of Change From Baseline in Corrected T1 (CT1)

  12 weeks

• Analysis of Change From Baseline in Alanine Aminotransferase (ALT)

  12 weeks

• Analysis of Change From Baseline in Gamma Glutamyltranspeptidase (GT)

  12 weeks

Study Arms (5)

Vonafexor 100 mg BID

EXPERIMENTAL

Oral dose twice daily for 12 weeks (84 days)

Drug: Vonafexor

Vonafexor 200 mg QD

EXPERIMENTAL

Oral dose once daily for 12 weeks (84 days)

Drug: Vonafexor

Vonafexor 400 mg QD

EXPERIMENTAL

Oral dose once daily for 12 weeks (84 days)

Drug: Vonafexor

Placebo

PLACEBO COMPARATOR

Oral dose twice daily for 12 weeks (84 days)

Other: Placebo

Vonafexor 100 mg QD

EXPERIMENTAL

Oral dose once daily for 12 weeks (84 days)

Drug: Vonafexor

Interventions

Vonafexor DRUG

Oral tablets

Vonafexor 100 mg BID; Vonafexor 100 mg QD; Vonafexor 200 mg QD; Vonafexor 400 mg QD

Placebo OTHER

Oral tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Enyo Pharma: lead

Study Sites (42)

ENYO PHARMA Investigative site 0424

North Little Rock, Arkansas, 72117, United States

Location

ENYO PHARMA Investigative site 0418

Lakewood Rch, Florida, 34211, United States

Location

ENYO PHARMA Investigative site 0402

Ocoee, Florida, 34761, United States

Location

ENYO PHARMA Investigative site 0420

Orlando, Florida, 32806, United States

Location

ENYO PHARMA Investigative site 0419

Port Orange, Florida, 32127, United States

Location

ENYO PHARMA Investigative site 0403

Athens, Georgia, 30607, United States

Location

ENYO PHARMA Investigative site 0423

Savannah, Georgia, 31406, United States

Location

ENYO PHARMA Investigative site 0407

Snellville, Georgia, 30078, United States

Location

ENYO PHARMA Investigative site 0409

Indianapolis, Indiana, 46260, United States

Location

ENYO PHARMA Investigative site 0413

Baton Rouge, Louisiana, 70809, United States

Location

ENYO PHARMA Investigative site 0404

Marrero, Louisiana, 70072, United States

Location

ENYO PHARMA Investigative site 0422

Baltimore, Maryland, 21202, United States

Location

ENYO PHARMA Investigative site 0412

Jackson, Mississippi, 39216, United States

Location

ENYO PHARMA Investigative site 0414

Kansas City, Missouri, 64131, United States

Location

ENYO PHARMA Investigative site 0406

Durham, North Carolina, 27710, United States

Location

ENYO PHARMA Investigative site 0411

Columbus, Ohio, 43213, United States

Location

ENYO PHARMA Investigative site 0401

Charleston, South Carolina, 29401, United States

Location

ENYO PHARMA Investigative site 0408

Charleston, South Carolina, 29407, United States

Location

ENYO PHARMA Investigative site 0421

Rapid City, South Dakota, 57701, United States

Location

ENYO PHARMA Investigative site 0405

Arlington, Texas, 76012, United States

Location

ENYO PHARMA Investigative site 0416

Austin, Texas, 78746, United States

Location

ENYO PHARMA Investigative site 0417

Edinburg, Texas, 78539, United States

Location

ENYO PHARMA Investigative site 0410

San Antonio, Texas, 78215, United States

Location

ENYO PHARMA Investigative site 0415

San Antonio, Texas, 78229, United States

Location

ENYO PHARMA Investigative site 0105

Brussels, 1070, Belgium

Location

ENYO PHARMA Investigative site 0101

Edegem, 2650, Belgium

Location

ENYO PHARMA Investigative site 0104

Ghent, 3000, Belgium

Location

ENYO PHARMA Investigative site 0103

Ghent, 9000, Belgium

Location

ENYO PHARMA Investigative site 0201

Angers, 49933, France

Location

ENYO PHARMA Investigative site

Créteil, 94010, France

Location

ENYO PHARMA Investigative site 0203

Limoges, 87000, France

Location

ENYO PHARMA Investigative site 0204

Lyon, 69004, France

Location

ENYO PHARMA Investigative site 0206

Paris, 75013, France

Location

ENYO PHARMA Investigative site 0202

Pessac, 33600, France

Location

ENYO PHARMA Investigative site 0207

Toulouse, 31059, France

Location

ENYO PHARMA Investigative site 0205

Villejuif, 94800, France

Location

ENYO PHARMA Investigative site 0429

San Juan, Puerto Rico

Location

ENYO PHARMA Investigative site 0304

Belfast, BT12 6BA, United Kingdom

Location

ENYO PHARMA Investigative site 0302

Cambridge, CB2 0QQ, United Kingdom

Location

ENYO PHARMA Investigative site 0303

London, E1 1BB, United Kingdom

Location

ENYO PHARMA Investigative site 0305

London, SE5 9RS, United Kingdom

Location

ENYO PHARMA Investigative site 0301

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36334688 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases

Results Point of Contact

• Title: Pietro Scalfaro
• Organization: ENYO Pharma SA

ps@enyopharma.com

+33437700219

Study Officials

• Harrison Stephen, MD

  Pinnacle Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple (Participant, Care Provider, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 22, 2019
• Study Start: January 30, 2019
• Primary Completion: June 16, 2021
• Study Completion: July 6, 2021
• Last Updated: May 6, 2023
• Results First Posted: May 6, 2023

Record last verified: 2023-04

Locations

US (24); GB (5); PR (1); FR (8); BE (4)