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

Sponsor
Enyo Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT03812029
Collaborator
(none)
120
Enrollment
42
Locations
5
Arms
29.2
Actual Duration (Months)
2.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Detailed Description

This is a 2-part, randomized, double-blind, multicenter, placebo-controlled study to evaluate the safety and efficacy of EYP001 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 EYP001a twice daily (BID), 200 mg EYP001a once daily (QD), 400 mg EYP001a QD, or placebo

BID. In Part B, 90 patients will be randomized on Day 1 to 1 of 3 parallel treatment groups:

100 mg EYP001a QD, 200 mg EYP001a QD, or placebo QD.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel assignmentParallel 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 :
Jan 30, 2019
Actual Primary Completion Date :
Jun 6, 2021
Actual Study Completion Date :
Jul 6, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: EYP001a 100 mg BID

Oral dose twice daily for 12 weeks (84 days)

Drug: EYP001a
Oral tablets
Experimental: EYP001a 200 mg QD

Oral dose once daily for 12 weeks (84 days)

Drug: EYP001a
Oral tablets
Experimental: EYP001a 400 mg QD

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
Experimental: EYP001a 100 mg QD

Oral dose once daily for 12 weeks (84 days)

Drug: EYP001a
Oral tablets

Outcome Measures

Primary Outcome Measures

  1. Change in absolute liver fat content as measured by MRI from Baseline to Week 12 [12 weeks]

  2. Safety profile of EYP001a - Frequency of adverse events [12 weeks]

    Frequency of adverse events

Secondary Outcome Measures

  1. % patients with relative reduction in liver fat ≥30% using MRI [12 weeks]

  2. relative reduction in liver fat [12 weeks]

  3. Percent change in liver imaging-derived mean iron-corrected T1 [12 weeks]

  4. Liver inflammation markers [12 weeks]

    Plasma concentration ALT and AST, ProC3, fibronectin, hyaluronic acid.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ENYO PHARMA Investigative site 0424 North Little Rock Arkansas United States 72117
2 ENYO PHARMA Investigative site 0418 Lakewood Ranch Florida United States 34211
3 ENYO PHARMA Investigative site 0402 Ocoee Florida United States 34761
4 ENYO PHARMA Investigative site 0420 Orlando Florida United States 32806
5 ENYO PHARMA Investigative site 0419 Port Orange Florida United States 32127
6 ENYO PHARMA Investigative site 0403 Athens Georgia United States 30607
7 ENYO PHARMA Investigative site 0423 Savannah Georgia United States 31406
8 ENYO PHARMA Investigative site 0407 Snellville Georgia United States 30078
9 ENYO PHARMA Investigative site 0409 Indianapolis Indiana United States 46260
10 ENYO PHARMA Investigative site 0413 Baton Rouge Louisiana United States 70809
11 ENYO PHARMA Investigative site 0404 Marrero Louisiana United States 70072
12 ENYO PHARMA Investigative site 0422 Baltimore Maryland United States 21202
13 ENYO PHARMA Investigative site 0412 Jackson Mississippi United States 39216
14 ENYO PHARMA Investigative site 0414 Kansas City Missouri United States 64131
15 ENYO PHARMA Investigative site 0406 Durham North Carolina United States 27710
16 ENYO PHARMA Investigative site 0411 Columbus Ohio United States 43213
17 ENYO PHARMA Investigative site 0401 Charleston South Carolina United States 29401
18 ENYO PHARMA Investigative site 0408 Charleston South Carolina United States 29407
19 ENYO PHARMA Investigative site 0421 Rapid City South Dakota United States 57701
20 ENYO PHARMA Investigative site 0405 Arlington Texas United States 76012
21 ENYO PHARMA Investigative site 0416 Austin Texas United States 78746
22 ENYO PHARMA Investigative site 0417 Edinburg Texas United States 78539
23 ENYO PHARMA Investigative site 0410 San Antonio Texas United States 78215
24 ENYO PHARMA Investigative site 0415 San Antonio Texas United States 78229
25 ENYO PHARMA Investigative site 0105 Brussels Belgium 1070
26 ENYO PHARMA Investigative site 0101 Edegem Belgium 2650
27 ENYO PHARMA Investigative site 0104 Gent Belgium 3000
28 ENYO PHARMA Investigative site 0103 Gent Belgium 9000
29 ENYO PHARMA Investigative site 0201 Angers France 49933
30 ENYO PHARMA Investigative site Créteil France 94010
31 ENYO PHARMA Investigative site 0203 Limoges France 87000
32 ENYO PHARMA Investigative site 0204 Lyon France 69004
33 ENYO PHARMA Investigative site 0206 Paris France 75013
34 ENYO PHARMA Investigative site 0202 Pessac France 33600
35 ENYO PHARMA Investigative site 0207 Toulouse France 31059
36 ENYO PHARMA Investigative site 0205 Villejuif France 94800
37 ENYO PHARMA Investigative site 0429 San Juan Puerto Rico
38 ENYO PHARMA Investigative site 0304 Belfast United Kingdom BT12 6BA
39 ENYO PHARMA Investigative site 0302 Cambridge United Kingdom CB2 0QQ
40 ENYO PHARMA Investigative site 0303 London United Kingdom E1 1BB
41 ENYO PHARMA Investigative site 0305 London United Kingdom SE5 9RS
42 ENYO PHARMA Investigative site 0301 Nottingham United Kingdom NG7 2UH

Sponsors and Collaborators

  • Enyo Pharma

Investigators

  • Principal Investigator: Harrison Stephen, MD, Pinnacle Clinical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Enyo Pharma
ClinicalTrials.gov Identifier:
NCT03812029
Other Study ID Numbers:
  • EYP001-202
  • 2018-003119-22
First Posted:
Jan 22, 2019
Last Update Posted:
Sep 20, 2021
Last Verified:
Sep 1, 2021
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:
Fatty Liver
Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Sep 20, 2021