A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis

Phase 2 Completed 134 enrolled Enanta Pharmaceuticals, Inc ICON Clinical Research · collab Triangle Biostatistics, LLC · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis

Timeline

Start: 2018-04-25
Primary completion: 2019-06-14
Completion: 2019-07-10

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs EDP-305 2.5 mg; p = 0.0495; Least Squares (LS) mean difference 12.460 (95% CI 0.029 to 24.891); ANCOVA NCT03421431 ↗

release “The study’s primary endpoint was achieved with a statistically significant ALT reduction of 28 U/L in the EDP-305 2.5mg arm” enanta.com ↗

Publications

Ratziu V, Rinella ME, Neuschwander-Tetri BA, Lawitz E, Denham D, Kayali Z, Sheikh A, Kowdley KV, Desta T, Elkhashab M, DeGrauw J, Goodwin B, Ahmad A, Adda N. EDP-305 in patients with NASH: A phase II double-blind placebo-controlled dose-ranging study. J Hepatol. 2022 Mar;76(3):506-517. doi: 10.1016/j.jhep.2021.10.018. Epub 2021 Nov 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EDP-305	Unknown	1 mg	Oral
Subject	EDP-305	Unknown	2.5 mg	Oral