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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
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.
Time frame: 12 weeks
Analysis of Change From Baseline in Glomerular Filtration rate_Part B
Time frame: 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)
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.
Time frame: 12 weeks
Analysis of Change From Baseline in Corrected T1 (CT1)
Time frame: 12 weeks
Analysis of Change From Baseline in Alanine Aminotransferase (ALT)
Time frame: 12 weeks
Analysis of Change From Baseline in Gamma Glutamyltranspeptidase (GT)
Time frame: 12 weeks
Analysis of Change From Baseline in Body Weight
Time frame: 12 weeks
Analysis of Change From Baseline in Waist Circumference
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ENYO PHARMA Investigative site 0424
North Little Rock, Arkansas, United States
ENYO PHARMA Investigative site 0418
Lakewood Rch, Florida, United States
ENYO PHARMA Investigative site 0402
Ocoee, Florida, United States
ENYO PHARMA Investigative site 0420
Orlando, Florida, United States
ENYO PHARMA Investigative site 0419
Port Orange, Florida, United States
ENYO PHARMA Investigative site 0403
Athens, Georgia, United States
ENYO PHARMA Investigative site 0423
Savannah, Georgia, United States
ENYO PHARMA Investigative site 0407
Snellville, Georgia, United States
ENYO PHARMA Investigative site 0409
Indianapolis, Indiana, United States
ENYO PHARMA Investigative site 0413
Baton Rouge, Louisiana, United States
...and 32 more locations
Time frame: 12 weeks
Analysis of Change From Baseline in Waist to Hip ratio_Part B
Time frame: 12 weeks
Analysis of Change From Baseline in Glomerular Filtration rate_Part A
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.
Time frame: 12 weeks