| Trial ID: | L0465 |
| Source ID: | EUCTR2018-004012-22-FR
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| Associated Drug: |
Resmetirom
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| Title: |
A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation
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| Acronym: |
--
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| Status: |
Authorised
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Non-Alcoholic Steatohepatitis (NASH) <br>
MedDRA version: 20.1
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepato
|
| Interventions: |
<br> Product Name: resmetirom<br> Product Code: MGL-3196<br> Pharmaceutical Form: Film-coated tablet<br> INN or Proposed INN: Resmetirom<br> CAS Number: 920509-32-6<br>
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| Outcome Measures: |
<br> Primary end point(s): NASH Resolution Response at Week 52 <br> <br> Time to Composite Clinical Outcome Event at Month 54<br> ;<br> Timepoint(s) of evaluation of this end point: Week 52.<br> <br> Month 54<br> ;<br> Main Objective: To determine the effect of once-daily, oral administration of 80 or 100 mg MGL 3196 versus matching placebo on NASH, as measured by:<br> 1. The resolution of NASH associated with an at least 2-point reduction in non alcoholic fatty liver disease (NAFLD) activity score (NAS) and without worsening of fibrosis by liver biopsy after 52 weeks of treatment (Week 52 Primary Endpoint) in the Week 52 population (defined as the first 900 F2 and F3 patients randomized, containing at least 450 F3 patients). <br> Resolution includes:<br> ?€? The total absence of ballooning (score = 0) and absent or mild inflammation (score 0 to 1) (associated with an at least 2-point reduction in NAS). <br> ?€? No worsening of fibrosis: worsening of fibrosis is defined as any progression =1 stage.<br> <br> 2. Time to experiencing an adjudicated Composite Clinical Outcome event in all F2 and F3 patients; Final Primary Endpoint, at 54 months.<br> ;<br> Secondary Objective: Key Secondary Objectives:<br> 1. To determine the effect of once-daily, oral administration of 80 or 100 mg MGL-3196 versus matching placebo on the percent change from Baseline at 24 weeks in low-density lipoprotein cholesterol (LDL-C).<br> 2. To determine the effect of once-daily, oral administration of 80 or 100 mg MGL-3196 versus placebo for 52 weeks in patients with biopsy-proven NASH on the histological improvement from Baseline demonstrated by at least a 1-point improvement in fibrosis by liver biopsy with no worsening of NAS (total of three NAS components, ballooning, inflammation and steatosis) (Fibrosis =1 Stage Responder).<br> <br> Secondary end point(s): Percent change from baseline in LDL-C
<br>
<br> Improvement in Fibrosis without Worsening of NAS
<br>
<br> Resolution of NASH
<br> ;<br> Timepoint(s) of evaluation of this end point: Week 52.
<br>
<br> Month 54<br>
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| Sponsor/Collaborators: |
Madrigal Pharmaceuticals, Inc.
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 3
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| Enrollment: |
2000
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
<br> Controlled: yes<br> Randomised: yes<br> Open: no<br> Single blind: no<br> Double blind: yes<br> Parallel group: yes<br> Cross over: no<br>
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| Start Date: |
03/06/2019
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
10 December 2019
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| Locations: |
United States;France;Hungary;Canada;Belgium;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-004012-22
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