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

Novartis Pharmaceuticals89 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Liver Disease

Interventions

triopifexorDRUG

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

PlaceboDRUG

Placebo capsules for oral administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Novartis Investigative Site

Madison, Alabama, United States

Novartis Investigative Site

Coronado, California, United States

Novartis Investigative Site

Miami, Florida, United States

Outcomes

Primary Outcomes

Change from baseline in fasting circulating LDL-C levels after 2 weeks of tropifexor treatment

Time frame: week 2

Secondary Outcomes

Change in fasting circulating High density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) levels over 4 weeks of treatment

Time frame: week 4

Change in ALT, AST and GGT over 4 weeks of treatment

Time frame: week 4

PK parameters include but not limited to Cmax (ng/ml) will be assessed in the domiciled patients

Time frame: week 4

PK parameters include but not limited to area under the curve (AUC) will be assessed in the domiciled patients

Time frame: 4 weeks

Data from ClinicalTrials.gov

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