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

Novartis

Status and phase: Completed; Phase 1

Conditions: Liver Disease

Treatments: Drug: triopifexor; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04408937

CLJN452A2113

Details and patient eligibility

About

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

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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89 participants in 2 patient groups

tropifexor AM 200 micrograms and Placebo (PM)

Experimental group

Description:

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

Treatment:

Drug: triopifexor

Drug: Placebo

tropifexor PM 200 micrograms and Placebo (AM)

Experimental group

Description:

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

Treatment:

Drug: triopifexor

Drug: Placebo