| Trial ID: | L0585 |
| Source ID: | EUCTR2015-005215-33-SK
|
| 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)
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Steatohepatitis (NASH) <br>MedDRA version: 20.1
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepatobiliary disorders
;Therapeutic area: Diseases [C] - Digestive System Diseases [C0
|
| Interventions: |
<br>Product Name: LJN452<br>Product Code: LJN452<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: Not available yet<br>Current Sponsor code: LJN452<br>Other descriptive name: LJN452<br>Concentration unit: ??g microgram(s)<br>Concentration typ
|
| Outcome Measures: |
Main Objective: The primary objective of the study is to determine safety and tolerability of different doses of tropifexor by monitoring adverse events.<br>Moreover, the study will determine the dose-response relationship of tropifexor on markers of hepatic inflammation in NASH by changes in ALT and AST from baseline to Week 12<br>The study will also determine the dose-response relationship of tropifexor on liver fat content by changes from baseline to week 12 in quantitative MRI determined fat;Secondary Objective: Effect of different doses of tropifexor on weight, BMI, waist-to-hip<br>(WTH) ratio)<br>To determine the dose-response relationship of tropifexor on<br>- markers of target engagement<br>- liver fibrosis markers<br>- GGT<br>- fasting lipid profile<br><br>- PK of tropifexor<br>- Effect of tropifexor vs PBO regarding occurrence of potential itch based<br>on a visual analog scale (VAS)<br>- Effects of LJN452 on primary endpoints in the subset of patients with<br>historical biopsy data, both overall and by subsets defined by fibrosis<br>score and/or NAS score as feasible<br><br>Additional Secondary Endpoints for Part C:<br>- safety / tolerability of different doses of tropifexor by monitoring AEs.<br>- dose-response relationship of tropifexor on markers of hepatic<br>inflammation in NASH (baseline to wk 48).<br>- dose-response relationship of tropifexor on liver fat content (MRI)<br>baseline to wk 48<br>- efficacy of tropifexor in NASH and F2/F3 fibrosis as assessed by<br>histological improvement from baseline to wk 48 vs PBO;Primary end point(s): Safety (to be assessed in the SAF):<br>- Occurrence of SAE<br>- Occurrence of AE resulting in permanent discontinuation or dose reduction of study treatment<br>- Occurrence of AE of special interest<br><br>Efficacy (to be assessed in the FAS):<br>- Change from baseline to Week 12 in ALT<br>- Change from baseline to Week 12 in AST<br>- Relative change from baseline to Week 12 in percentage of fat in the liver assessed using MRI;Timepoint(s) of evaluation of this end point: 12 weeks of treatmentSecondary end point(s): Absolute change from baseline to Week 12 in percentage of fat in the liver assessed using MRI
<br>
<br>Weight, BMI, waist-to-hip (WTH) ratio
<br>
<br>FGF19, C4
<br>
<br>Liver stiffness (in kPa) by Fibroscan??, enhanced liver fibrosis panel (ELF) score, and score of fibrosis biomarker test (originally known as Fibrotest??/ FibroSure??)
<br>
<br>GGT
<br>
<br>Fasting lipids (total cholesterol, trigylcerides, LDL and HDL cholesterol, free glycerol, free fatty acids)
<br>
<br>Itch VAS
<br>
<br>At least a one point improvement of fibrosis stage without worsening of
<br>steatohepatitis at Week 48 compared to baseline
<br>Proportion of patients who have at least a two point improvement in
<br>fibrosis without worsening of steatohepatitis at Week 48 compared to
<br>baseline
<br>Resolution of steatohepatitis without worsening of fibrosis stage at
<br>Week 48 compared to baseline
<br>Change of NAS from baseline to Week 48
<br>
<br>Absolute and relative change from baseline to Week 48 in percentage of
<br>fat in the liver assessed using MRI
<br>Change from baseline to Week 48 of ALT and AST;Timepoint(s) of evaluation of this end point: 12 respectively 48 weeks of treatment
|
| Sponsor/Collaborators: |
Novartis Pharma Services AG
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Phase 2
|
| Enrollment: |
345
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 8
|
| Start Date: |
10/05/2016
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
11 May 2020
|
| Locations: |
United States;Taiwan;Slovakia;Spain;Austria;Italy;France;Canada;Belgium;Singapore;Australia;Germany;Netherlands;Korea, Republic of
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005215-33
|
