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

Phase 1

Completed

• Conditions: Liver Disease
• Interventions: Drug: triopifexor; Drug: Placebo

• Registration Number: NCT04408937
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed 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 Timeline

• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Study Start: 2020-05-29
• Study First Posted: 2020-05-29
• Primary Completion: 2020-11-04
• Study Completion: 2020-11-04
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

-Presence of Liver Disease

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tropifexor AM 200 micrograms and Placebo (PM)	Placebo	Tropifexor 200 μg (AM) and Placebo (PM) once daily each
tropifexor AM 200 micrograms and Placebo (PM)	triopifexor	Tropifexor 200 μg (AM) and Placebo (PM) once daily each
tropifexor PM 200 micrograms and Placebo (AM)	Placebo	Tropifexor 200 μg (PM) and Placebo (AM) once daily each
tropifexor PM 200 micrograms and Placebo (AM)	triopifexor	Tropifexor 200 μg (PM) and Placebo (AM) once daily each

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
PK parameters include but not limited to area under the curve (AUC) will be assessed in the domiciled patients	4 weeks
Change in fasting circulating High density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) levels over 4 weeks of treatment	week 4
PK parameters include but not limited to Cmax (ng/ml) will be assessed in the domiciled patients	week 4
Change in ALT, AST and GGT over 4 weeks of treatment	week 4

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 San Antonio, Texas, United States