| Trial ID: | L0440 |
| Source ID: | JPRN-JapicCTI-205120
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| Associated Drug: |
Elobixibat
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| Title: |
Efficacy and Safety of Elobixibat in Combination With Cholestyramine for Patients With Nonalcoholic Fatty Liver Disease: a Single Center, Double-blind, Randomized, Placebo-Controlled, Phase 2a Trial.
|
| Acronym: |
--
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| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH)
|
| Interventions: |
Intervention name : Elobixibat<br>INN of the intervention : Elobixibat<br>Dosage And administration of the intervention : Elobixibat 10mg once a day for 16 weeks<br>Intervention name : cholestylamine<br>INN of the intervention : cholestylamine<br>Dosage A
|
| Outcome Measures: |
efficacy<br>Absolute change from baseline in serum LDL-C at Week 16safety, efficacy, exploratory<br>Efficacy:<br>1, Absolute change from baseline to Week 16 in the liver fat fraction <br>2, Absolute change from baseline to Week 16 in hepatic fibrosis as measured by MRE<br>3, Change from baseline to Week 16 in the following: <br>ALT, AST, gammma-glutamyl transpeptidase (GGT), HDL-C, non-HDL-C, LDL-C/HDL-C ratio and TG<br><br>Safety:<br>1, Incidence of adverse events in the active drug groups compared with the placebo groups<br>2, Change from baseline in the daily score of the Bristol Stool Form Scale , the number of bowel movements and the Patient Assessment of Constipation Quality of Life (PAC-QOL) at every visit<br>3, Change from baseline in the Chronic Liver Disease Questionnaire (CLDQ) scale at every visit
|
| Sponsor/Collaborators: |
Takaomi Kessoku
|
| Gender: |
All
|
| Age: |
2075
|
| Phases: |
Phase 2
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| Enrollment: |
100
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Single-center, randomized, double-blind, placebo-controlled, parallel-group comparison study
|
| Start Date: |
21/01/2020
|
| Completion Date: |
30/09/2021
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| Results First Posted: |
--
|
| Last Update Posted: |
27 December 2021
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| Locations: |
Japan
|
| URL: |
https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-205120
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