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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-29

Study Completion Date

2020-11-04

Brief Summary

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

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Detailed Description

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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.

Conditions

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Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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tropifexor AM 200 micrograms and Placebo (PM)

Tropifexor 200 μg (AM) and Placebo (PM) once daily each

Group Type EXPERIMENTAL

triopifexor

Intervention Type DRUG

Tropifexor as a dry blend in hard gelatin capsules for oral administration

Placebo

Intervention Type DRUG

Placebo capsules for oral administration

tropifexor PM 200 micrograms and Placebo (AM)

Tropifexor 200 μg (PM) and Placebo (AM) once daily each

Group Type EXPERIMENTAL

triopifexor

Intervention Type DRUG

Tropifexor as a dry blend in hard gelatin capsules for oral administration

Placebo

Intervention Type DRUG

Placebo capsules for oral administration

Interventions

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triopifexor

Tropifexor as a dry blend in hard gelatin capsules for oral administration

Intervention Type DRUG

Placebo

Placebo capsules for oral administration

Intervention Type DRUG

Other Intervention Names

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LJN452

Eligibility Criteria

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Inclusion Criteria

-Presence of Liver Disease

Exclusion Criteria

* Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.
* Subjects taking the following medicines UNLESS on a stable dose (within 25% of baseline dose) for at least 3 months before randomization:

Type 1 diabetes and Uncontrolled Type 2 diabetes defined as Glycated hemoglobin (HbAlc) ≥ 9.5% at screening

-Calculated estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73m2 (using the Modification of diet in renal disease (MDRD) formula) Subjects with contraindications to Magnetic resonance imaging (MRI) imaging.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No