| Trial ID: | L0561 |
| Source ID: | EUCTR2016-002833-31-GB
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| Associated Drug: |
LMB763
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| Title: |
A randomized, patient and investigator blinded, placebo-controlled, multicenter study to assess the safety, tolerability, pharmacokinetics and efficacy of LMB763 in patients with non-alcoholic steatohepatitis (NASH)
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| Acronym: |
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| Status: |
Not Recruiting
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| Study Results: |
Has Results
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| Results: |
https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-002833-31/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 - Hepatobiliary disorders
;Therapeutic area: Diseases [C] - Digestive System Diseases [
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| Interventions: |
<br>Product Code: LMB763<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: Not established<br>CAS Number: Not assigned<br>Other descriptive name: LMB763<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration numbe
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| Outcome Measures: |
Main Objective: - To determine the safety and tolerability of LMB763 during 12 weeks of treatment<br>- To determine the effect of LMB763 on circulating alanine aminotransferase (ALT) levels<br>;Secondary Objective: - To evaluate the pharmacokinetics (PK) of LMB763 in NASH patients<br>- To determine the effect of LMB763 on intrahepatic lipid after 12 weeks of treatment<br>- To determine the effect of LMB763 on anthropometric assessments after 12 weeks of treatment <br>- To determine the effect of LMB763 on non-invasive markers of liver fibrosis <br>- To determine the effect of LMB763 on fasting lipid profile<br>- To determine the effect of LMB763 compared with placebo with respect to occurrence and impact of potential itch <br>;Primary end point(s): Change from baseline in ALT;Timepoint(s) of evaluation of this end point: 12 weeksSecondary end point(s): - Efficacy / Pharmacodynamics
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| Sponsor/Collaborators: |
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| Gender: |
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| Age: |
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| Phases: |
Not applicable
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| Enrollment: |
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| Study Type: |
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| Study Designs: |
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| Start Date: |
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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: |
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| URL: |
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