| Trial ID: | L0999 |
| Source ID: | EUCTR2019-002324-32-BE
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| Associated Drug: |
Tropifexor
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| Title: |
Study of safety, tolerability and efficacy of a combination treatment of tropifexor (LJN452) & licogliflozin (LIK066) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis
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| Acronym: |
--
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| Status: |
--
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| Study Results: |
--
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| Results: |
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| Conditions: |
Non-alcoholic Steatohepatitis (NASH) <br>
MedDRA version: 22.0
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepato
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| Interventions: |
<br> Product Name: Tropifexor<br> Product Code: LJN452<br> Pharmaceutical Form: Capsule, hard<br> INN or Proposed INN: TROPIFEXOR<br> Current Sponsor code: LJN452<br>
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| Outcome Measures: |
<br> Primary end point(s): Proportion of patients with resolution of NASH and no worsening of fibrosis OR improvement in fibrosis by at least one stage without worsening of NASH at Week 48 compared with baseline. <br> To demonstrate the efficacy of tropifexor + licogliflozin as assessed by histologic improvement after 48 weeks of combination treatment compared to each monotherapy treatment in patients with NASH and stage 2 or 3 fibrosis.<br> ;<br> Secondary Objective: Improvement in fibrosis by at least one stage with no worsening of NASH after 48 weeks of treatment.<br> Resolution of NASH with no worsening of fibrosis after 48 weeks of treatment.<br> Improvement in fibrosis by at least one stage.<br> Improvement in fibrosis by at least two stages with no worsening of NASH after 48 weeks treatment.<br> Reduction in body weight from baseline after 48 weeks of treatment.<br> Change in liver fat content after 48 weeks of treatment.<br> To determine the relationship of investigational treatment and markers of hepatic inflammation in NASH (ALT and AST).<br> To determine the relationship of investigational treatment and GGT, a marker of cholestasis and oxidative stress.<br> To evaluate the safety and tolerability of tropifexor in combination with licogliflozin, compared to monotherapy of each compound.<br> ;Timepoint(s) of evaluation of this end point: 48 weeks;Main Objective: The primary objective of the study is to demonstrate the efficacy of tropifexor + licogliflozin as assessed by histologic improvement after 48 weeks of combination treatment compared to each mono treatment in patients with NASH and stage 2 or 3 fibrosis.
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| Sponsor/Collaborators: |
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| Gender: |
All
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| Age: |
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| Phases: |
Phase 2
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| Enrollment: |
210
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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: |
2019/12/13
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| Completion Date: |
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| Results First Posted: |
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| Last Update Posted: |
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| Locations: |
Bulgaria;Germany;Japan;Singapore;Belgium;Brazil;Argentina;Canada;Mexico;Egypt;United Kingdom;Turkey;Korea, Republic of;China;South Africa;Denmark;France;India;Italy;Colombia;Russian Federation;Chile;Spain;Estonia;Taiwan;Saudi Arabia;United States
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-002324-32
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