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

NCT03812029 ↗

Phase 2 Completed 120 enrolled Enyo Pharma

RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start: 2019-01-30
Primary completion: 2021-06-16
Completion: 2021-07-06

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo Part B vs Vonafexor 100 mg QD Part B; p = 0.0015; ANCOVA; note: a priori threshold for statistical significance : \<0.05. NCT03812029 ↗

registry analysis (superiority test); Placebo Part B vs Vonafexor 200 mg QD Part B; p = 0.0121; ANCOVA; note: a priori threshold for statistical significance : \<0.05. NCT03812029 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vonafexor	Small molecule	100 mg	Oral
Subject	Vonafexor	Small molecule	200 mg	Oral
Subject	Vonafexor	Small molecule	400 mg	Oral