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The Purpose of This Study is to Investigate Safety and Tolerability of Tropifexor.

Liver Disease Clinical Trial

Official title:
A Randomized, Investigator and Subject Blinded, Multicenter, Parallel-arm Study to Determine the Safety and Tolerability of Tropifexor.

Clinical Trial Summary

The purpose of this study is to determine whether dosing tropifexor is safe and tolerable.

Clinical Trial Description

This was a randomized, subject and investigator blinded, multicenter, parallel-arm study to assess the safety and tolerability of tropifexor dosed in the evening as compared to dosing in the morning in subjects with non-alcoholic steatohepatitis (NASH). Subjects whose eligibility was confirmed were randomized with stratification by domicile status at Day 1 of the treatment period into tropifexor (200 μg) AM dose group (hereafter referred to as AM dose group) or tropifexor (200 μg) PM dose group (hereafter referred to as PM dose group) in a 1:1 ratio. Subjects in the AM dose group took tropifexor in the morning and placebo in the evening while subjects in the PM dose group took placebo in the morning and tropifexor in the evening for 4 weeks in a blinded manner. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04408937
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 1
Start date May 29, 2020
Completion date November 4, 2020
View Details
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