Liver Disease
Conditions
Keywords
tropifexor, FXR agonist
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.
Interventions
DRUGtriopifexor
Tropifexor as a dry blend in hard gelatin capsules for oral administration
DRUGPlacebo
Placebo capsules for oral administration
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting circulating LDL-C levels after 2 weeks of tropifexor treatment | week 2 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change in ALT, AST and GGT 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 |
| PK parameters include but not limited to area under the curve (AUC) will be assessed in the domiciled patients | 4 weeks |
Countries
United States
Outcome results
None listed