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

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ClinicalTrials.gov Identifier: NCT03812029
Recruitment Status : Recruiting
First Posted : January 21, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Enyo Pharma

Brief 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

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis Drug: EYP001a Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020


Arm Intervention/treatment
Experimental: EYP001a Dose 1
Oral dose twice daily for 12 weeks (84 days)
Drug: EYP001a
Oral tablets

Experimental: EYP001a Dose 2
Oral dose once daily for 12 weeks (84 days)
Drug: EYP001a
Oral tablets

Experimental: EYP001a Dose 3
Oral dose once daily for 12 weeks (84 days)
Drug: EYP001a
Oral tablets

Placebo Comparator: Placebo
Oral dose twice daily for 12 weeks (84 days)
Other: Placebo
Oral tablets




Primary Outcome Measures :
  1. Change in absolute liver fat content as measured by MRI from Baseline to Week 12 [ Time Frame: 12 weeks ]
  2. Safety profile of EYP001a - Frequency of adverse events [ Time Frame: 12 weeks ]
    Frequency of adverse events


Secondary Outcome Measures :
  1. % patients with relative reduction in liver fat ≥30% using MRI [ Time Frame: 12 weeks ]
  2. relative reduction in liver fat [ Time Frame: 12 weeks ]
  3. Percent change in liver imaging-derived mean iron-corrected T1 [ Time Frame: 12 weeks ]
  4. Liver inflammation markers [ Time Frame: 12 weeks ]
    Plasma concentration ALT and AST, ProC3, fibronectin, hyaluronic acid.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812029


Contacts
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Contact: Couchoux Harold 33 (0)437 700 246 202@enyopharma.com

  Show 41 Study Locations
Sponsors and Collaborators
Enyo Pharma
Investigators
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Principal Investigator: Harrison Stephen, MD Pinnacle Clinical Research

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Responsible Party: Enyo Pharma
ClinicalTrials.gov Identifier: NCT03812029     History of Changes
Other Study ID Numbers: EYP001-202
2018-003119-22 ( EudraCT Number )
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enyo Pharma:
EYP001
Liver Diseases
Non-alcoholic Fatty Liver Disease
Non-alcoholic Steatohepatitis
NASH
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases