Phase 2
Completed N=120
Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH)
Source: ClinicalTrials.gov NCT03812029 ↗Enrolled (actual)
120
Serious AEs
3.3%
Results posted
May 2023
Primary outcomePrimary: 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) — -2.3; -6.3; -5.4; 3.9 Percentage of liver fat change — p=0.0015
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
-2.3; -6.3; -5.4; 3.9; -4.7 | 0.0015 sig |
| SECONDARY Analysis of Change From Baseline in Glomerular Filtration rate_Part B |
-2.7; 6.2; 3.2 | 0.003 sig |
| SECONDARY 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) |
-10.5; -30.4; -25.3; 11.7; -25.0 | 0.0017 sig |
| SECONDARY Analysis of Change From Baseline in Corrected T1 (CT1) |
-9.9; -80.2; -71.8; 35.0; -58.2 | 0.001 sig |
| SECONDARY Analysis of Change From Baseline in Alanine Aminotransferase (ALT) |
-11.7; -16.3; -7.5; -4.1; 17.7 | 0.09 |
| SECONDARY Analysis of Change From Baseline in Gamma Glutamyltranspeptidase (GT) |
-3.9; -40.6; -34.1; 3.7; -25.2 | <0.0001 sig |
| SECONDARY Analysis of Change From Baseline in Body Weight |
-0.1; -1.7; -2.5; 1.2; -2.2 | 0.017 sig |
| SECONDARY Analysis of Change From Baseline in Waist Circumference |
0.1; -1.2; -2.2; -1.8; -2.9 | 0.16 |
| SECONDARY Analysis of Change From Baseline in Waist to Hip ratio_Part B |
0.014; -0.017; -0.010 | 0.0017 sig |
| SECONDARY Analysis of Change From Baseline in Glomerular Filtration rate_Part A |
-4; -11.3 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03812029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.