The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis

Summary

This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of LPCN 1144 in adult men with NASH.

Timeline

Start

2019-08-27

Primary completion

2021-06-24

Completion

2021-06-24

Outcome

Met primary endpoint

registry analysis (superiority test); Treatment A vs Treatment C; p <0.0001; ANCOVA NCT04134091 ↗

registry analysis (superiority test); Treatment B vs Treatment C; p <0.0001; ANCOVA NCT04134091 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Testosterone Undecanoate	Small molecule	225 mg	Oral
Subject	d-alpha tocopherol	Unknown	238 mg	Oral

Indications