| Trial ID: | L0469 |
| Source ID: | ACTRN12619000610134
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| Associated Drug: |
LM011
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| Title: |
An open-label study to assess the efficacy and safety of LM011 in subjects diagnosed with Non-Alcoholic Steatohepatitis (NASH)
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| Acronym: |
--
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| Status: |
Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Non-Alcoholic Steatohepatitis (NASH); <br>Non-Alcoholic Steatohepatitis (NASH);Metabolic and Endocrine - Metabolic disorders;Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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| Interventions: |
LM-011-18-01 is a single arm open label study to test the safety and effectiveness of LM-011 in patients diagnosed with ?€?nonalcoholic steatohepatitis?€? (NASH).<br> <br>20 NASH patients will be enrolled and receive orally LM011 once a day for a duration
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| Outcome Measures: |
Percent change from Screening in liver fat fraction (%), measured by Magnetic Resonance Imaging-derived proton density fat fraction (MRI-PDFF).<br><br>MRI-PDFF data will be collected at screening visit and at end-of-study visit (Week 16) for all individual subjects. If there are subjects with missing Week-16 MRI-PDFF data due to drop out, regardless of reasons, two types of analyses will be performed. The first type of analysis will exclude the subject(s) who drop out, while the second type will include the drop-out subject(s) but will assume LM011 has no effect on ?€?liver fat fraction?€? on these subject(s).<br>[16 weeks];Proportion of subjects with at least a 25% decrease in % steatosis<br><br>The percentage change is calculated by taking the difference between the baseline and Week 16 measurements and divide the difference by the baseline value . Similar to that described above for the analysis of the first Primary Endpoint, two types of analysis will also be performed. For subjects drop out early, the first type of analysis will exclude the subject(s) who drop out, while the second type of analysis will include all subject(s) and will assume LM011 had no effect on liver fat fraction on the subjects who drop out early. <br><br>At Screening and Week 16, MRI-PDFF over 9 regions of interest will provide estimates of liver fat fractions, measured in %. Based on this biomarker, % steatosis of the liver can be estimated. <br>The percentage change is calculated by taking the difference between the Screening and Week 16 measurements in % steatosis and divide the difference by the Screening % steatosis. <br>Proportion of subjects with at least 25% decrease will be summarized. [16 weeks]Change in liver fat fraction by MRI-PDFF[16 weeks or 11 weeks if the subjects early terminated from the study.];Change in aspartate aminotransferase (AST) based on chemistry laboratory test results.
<br>AST will be analyzed with a serum assay.[16 weeks or 11 weeks if the subjects early terminated from the study.];Change in alanine aminotransferase (ALT) based on chemistry laboratory test results.
<br>ALT will be analyzed with a serum assay.[16 weeks or 11 weeks if the subjects early terminated from the study.];Change in enhanced Liver Fibrosis (ELF) Score[16 weeks or 11 weeks if the subjects early terminated from the study.];Percentage of subjects with at least 15% reduction in liver steatosis
<br>
<br>The percentage change is calculated by taking the difference between the baseline and Week 16 measurements and divide the difference by the baseline value. Thus, for conditions with some subjects drop out of study early (hence no measurement on ?€?liver fat fraction?€? was collected for Week 16), two types of analyses will be conducted: the first analysis will exclude subject(s) who did not complete the study, while the second analysis will include subject(s) who drop out of study early, but will assume LM011 had no effect on liver fat fraction .
<br>
<br>
<br>At Screening and Week 16, MRI-PDFF over 9 regions of interest will provide estimates of liver fat fractions, measured in %. Based on this biomarker, % steatosis of the liver can be estimated.
<br>The percentage change is calculated by taking the difference between the Screening and Week 16 measurements in % steatosis and divide the difference by the Screening % steatosis. Proportion of subjects with at least 15% decrease will be summarized.
<br>The calculation is the same as the primary outcome. The only difference is that 15% cutoff is to be used.[16 weeks or 11 weeks if the subjects early terminated from the study.]
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| Sponsor/Collaborators: |
Lifemax Laboratories (Australia) Pty Ltd
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| Gender: |
All
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| Age: |
18 Years75 Years
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| Phases: |
Phase 2
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| Enrollment: |
20
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| Study Type: |
Interventional
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| Study Designs: |
Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
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| Start Date: |
23/04/2019
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
15 July 2019
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| Locations: |
Australia
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| URL: |
https://anzctr.org.au/ACTRN12619000610134.aspx
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