search
Back to results

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

Primary Purpose

Liver Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
triopifexor
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Disease focused on measuring tropifexor, FXR agonist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

tropifexor AM 200 micrograms and Placebo (PM)

tropifexor PM 200 micrograms and Placebo (AM)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 28, 2020
Last Updated
February 7, 2022
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT04408937
Brief Title
The Purpose of This Study is to Investigate Safety and Tolerability of Tropifexor.
Official Title
A Randomized, Investigator and Subject Blinded, Multicenter, Parallel-arm Study to Determine the Safety and Tolerability of Tropifexor.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
November 4, 2020 (Actual)
Study Completion Date
November 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease
Keywords
tropifexor, FXR agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tropifexor AM 200 micrograms and Placebo (PM)
Arm Type
Experimental
Arm Description
Tropifexor 200 μg (AM) and Placebo (PM) once daily each
Arm Title
tropifexor PM 200 micrograms and Placebo (AM)
Arm Type
Experimental
Arm Description
Tropifexor 200 μg (PM) and Placebo (AM) once daily each
Intervention Type
Drug
Intervention Name(s)
triopifexor
Other Intervention Name(s)
LJN452
Intervention Description
Tropifexor as a dry blend in hard gelatin capsules for oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules for oral administration
Primary Outcome Measure Information:
Title
Change from baseline in fasting circulating LDL-C levels after 2 weeks of tropifexor treatment
Time Frame
week 2
Secondary Outcome Measure Information:
Title
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
Title
Change in ALT, AST and GGT over 4 weeks of treatment
Time Frame
week 4
Title
PK parameters include but not limited to Cmax (ng/ml) will be assessed in the domiciled patients
Time Frame
week 4
Title
PK parameters include but not limited to area under the curve (AUC) will be assessed in the domiciled patients
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Novartis Investigative Site
City
Madison
State/Province
Alabama
ZIP/Postal Code
35758
Country
United States
Facility Name
Novartis Investigative Site
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33014-3616
Country
United States
Facility Name
Novartis Investigative Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Novartis Investigative Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46635
Country
United States
Facility Name
Novartis Investigative Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Novartis Investigative Site
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Novartis Investigative Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208-2312
Country
United States
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=975
Description
A Plain Language Trial Summary is available on novctrd.com
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17871
Description
Results for CLJN452A2113 can be found on the Novartis Clinical Trial Results Website.

Learn more about this trial

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

We'll reach out to this number within 24 hrs