Clincosm LogoSign in Get a demo

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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04408937
Collaborator
(none)
89
Enrollment
10
Locations
2
Arms
5.2
Actual Duration (Months)
8.9
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
89 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Investigator and Subject Blinded, Multicenter, Parallel-arm Study to Determine the Safety and Tolerability of Tropifexor.
Actual Study Start Date :
May 29, 2020
Actual Primary Completion Date :
Nov 4, 2020
Actual Study Completion Date :
Nov 4, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: tropifexor AM 200 micrograms and Placebo (PM)

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

Drug: triopifexor
Tropifexor as a dry blend in hard gelatin capsules for oral administration
Other Names:
  • LJN452

    • Drug: Placebo
    Placebo capsules for oral administration
    Experimental: tropifexor PM 200 micrograms and Placebo (AM)

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

    Drug: triopifexor
    Tropifexor as a dry blend in hard gelatin capsules for oral administration
    Other Names:
  • LJN452

    • Drug: Placebo
    Placebo capsules for oral administration

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in fasting circulating LDL-C levels after 2 weeks of tropifexor treatment [week 2]

    Secondary Outcome Measures

    1. 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]

    2. Change in ALT, AST and GGT over 4 weeks of treatment [week 4]

    3. PK parameters include but not limited to Cmax (ng/ml) will be assessed in the domiciled patients [week 4]

    4. PK parameters include but not limited to area under the curve (AUC) will be assessed in the domiciled patients [4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Madison Alabama United States 35758
    2 Novartis Investigative Site Coronado California United States 92118
    3 Novartis Investigative Site Miami Florida United States 33014-3616
    4 Novartis Investigative Site Pensacola Florida United States 32503
    5 Novartis Investigative Site South Bend Indiana United States 46635
    6 Novartis Investigative Site Morehead City North Carolina United States 28557
    7 Novartis Investigative Site Hermitage Tennessee United States 37076
    8 Novartis Investigative Site Knoxville Tennessee United States 37920
    9 Novartis Investigative Site Dallas Texas United States 75208-2312
    10 Novartis Investigative Site San Antonio Texas United States 78215

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04408937
    Other Study ID Numbers:
    • CLJN452A2113
    First Posted:
    May 29, 2020
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    tropifexor
    FXR agonist
    Additional relevant MeSH terms:
    Liver Diseases

    Study Results

    No Results Posted as of Feb 9, 2022