| Trial ID: | L0396 |
| Source ID: | EUCTR2020-005187-63-HU
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| Associated Drug: |
FM101
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| Title: |
A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults with Nonalcoholic Fatty Liver Disease (NAFLD) or Nonalcoholic Steatohepatitis (NASH) - Phase II Nonalcoholic Steatohepatitis (NASH) study
|
| 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: |
Nonalcoholic Fatty Liver Disease (NAFLD) or Nonalcoholic Steatohepatitis (NASH) <br>MedDRA version: 22.0
Level: LLT
Classification code 10029530
Term: Non-alcoholic fatty liver
System Organ Class: 10019805 - Hepatobiliary disorders
<br>MedDRA version: 22
|
| Interventions: |
<br>Product Name: Not Applicable<br>Product Code: FM101<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: Not Assigned<br>Current Sponsor code: FM101<br>Other descriptive name: 20191002CM001 - FM101/STG-03<br>Concentration unit: mg millig
|
| Outcome Measures: |
Main Objective: To assess the safety and tolerability of 13 weeks of treatment with FM101 in patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH)<br><br>To assess the treatment effect of FM101 on serum alanine aminotransferase (ALT) concentrations after 13??weeks of treatment<br><br>;Secondary Objective: To assess the effect of 13 weeks of treatment with FM101 on the change in liver stiffness (kPa) measured by magnetic resonance imaging- (MRI)-magnetic resonance elastography (MRE) in patients with NAFLD or NASH<br>;Primary end point(s): 1. Number and percentage of patients with TEAEs, related TEAEs, and/or severe TEAEs [Time Frame: From administration of FM101 on Day 1 to the last follow up visit] <br>2. Change from Baseline to postbaseline assessments during 13 weeks of treatment in serum ALT concentrations<br>;Timepoint(s) of evaluation of this end point: 1. Time Frame: From administration of FM101 on Day 1 to the last follow up visit<br>2. during 13 weeksSecondary end point(s): Changes from Baseline to Week 13 in liver stiffness (kPa) on MRE. ;Timepoint(s) of evaluation of this end point: From Baseline to Week 13
|
| Sponsor/Collaborators: |
Future Medicine Co., Ltd.
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| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Phase 2
|
| Enrollment: |
60
|
| 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: 3
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| Start Date: |
11/02/2021
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| Completion Date: |
--
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| Results First Posted: |
--
|
| Last Update Posted: |
26 April 2021
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| Locations: |
Hungary;Spain;Poland
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005187-63
|
