| Trial ID: | L0522 |
| Source ID: | JPRN-JapicCTI-173735
|
| Associated Drug: |
Tropifexor
|
| Title: |
A Randomized, Double-blind, Placebo Controlled, 3- Part, Adaptive Design, Multicenter Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH): FLIGHT-FXR
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
Has Results
|
| Results: |
https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-173735
|
| Conditions: |
Non-alcoholic Steatohepatitis
|
| Interventions: |
Intervention name : LJN452 <br>INN of the intervention : Tropifexor<br>Dosage And administration of the intervention : LJN452 capsules, once daily p.o. (Comparison of different doses of drug)<br>Control intervention name : Placebo<br>INN of the control in
|
| Outcome Measures: |
safety<br>Adverse event profile of different doses of LJN452 in patients with NASH [ Time Frame: 12 weeks ]<br>Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline to week 12<br>efficacy<br>Change in Transaminase levels [ Time Frame: 12 weeks ]<br>To determine the dose relationship of LJN42 on markers of hepatic inflammation in NASH (ALT and AST)<br>Change from baseline in % of fat in the liver assessed using MRI [ Time Frame: 12 weeks ]<br>To determine the dose-response relationship of LJN452 on liver fat content by changes in quantitative MRIefficacy<br>Change from baseline in weight [ Time Frame: 12 weeks ]<br>To determine the effect of different doses of LJN452 on weight, after 12 weeks of treatment<br>efficacy<br>Change from baseline in biomarker FGF19 [ Time Frame: 6 weeks ]<br>To determine the dose-response relationship of LJN452 on FGF19 over time, a marker of FXR target engagement in the gut.<br>efficacy<br>Change from baseline on on markers of liver fibrosis [ Time Frame: 12 weeks ]<br>To determine the dose-response relationship of LJN452 on markers of liver fibrosis commonly available such as Fibroscan, enhanced liver fibrosis panel (ELF), and fibrosis biomarker test (originally known as Fibrotest/ FibroSure)<br>efficacy<br>Change from baseline on gamma-glutamyl transferase (GGT) [ Time Frame: 12 weeks ]<br>To determine the dose-response relationship of LJN452 on GGT, a marker of cholestasis
|
| Sponsor/Collaborators: |
Novartis Pharma K. K.
|
| Gender: |
All
|
| Age: |
18nan
|
| Phases: |
Phase 2
|
| Enrollment: |
345
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Randomized, Double-blind, Placebo Controlled, 3-part, Adaptive Design, Multicenter study
|
| Start Date: |
17/10/2017
|
| Completion Date: |
07/10/2020
|
| Results First Posted: |
15/09/2021
|
| Last Update Posted: |
18 October 2021
|
| Locations: |
Japan, Asia except Japan, North America, South America, Europe, Oceania
|
| URL: |
https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-173735
|
