| Trial ID: | L0496 |
| Source ID: | EUCTR2017-004365-27-FR
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| Associated Drug: |
EDP-305
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| Title: |
A Phase 2 Dose Ranging, Randomized, Double Blind, and Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Non-Alcoholic Steatohepatitis (NASH)
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| Acronym: |
--
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| Status: |
Not 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>
MedDRA version: 20.1
Level: PT
Classification code 10029530
Term: Non-alcoholic fatty liver
System Organ Class: 10019805 - Hepatobil
|
| Interventions: |
<br> Product Name: EDP-305<br> Product Code: EDP-305<br> Pharmaceutical Form: Tablet<br> INN or Proposed INN: Not available<br> CAS Number: 1933507-63-1<br> Current
|
| Outcome Measures: |
<br> Main Objective: - To evaluate change in alanine aminotransferase (ALT) levels<br> - To evaluate the safety and tolerability of EDP-305 <br> ;<br> Secondary Objective: - To evaluate the effect of EDP-305 on liver fat <br> - To evaluate the effect of EDP-305 on fibrosis (liver stiffness)<br> - To evaluate the effect of EDP-305 on noninvasive liver fibrosis markers<br> - To evaluate the effects of EDP-305 on lipids <br> - To evaluate the effects of EDP-305 on glucose metabolism<br> - To evaluate the effects of EDP-305 on inflammatory markers<br> - To evaluate the pharmacokinetics (PK) of EDP-305 and its metabolites in plasma<br> - To evaluate the effect of EDP-305 on body weight<br> - To evaluate the effect of EDP-305 on waist to hip (WTH) ratio<br> - To evaluate the pharmacodynamics of EDP-305<br> ;<br> Primary end point(s): - Change from baseline in ALT levels at Week 12<br> - Frequency of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation through Week 12 <br> ;Timepoint(s) of evaluation of this end point: Week 12<br> Secondary end point(s): - Change from Baseline in percentage of fat in the liver as assessed by magnetic resonance imaging-estimated proton density fat fraction (MRI PDFF) at Week 12
<br> - Change from Baseline in liver stiffness as assessed by magnetic resonance elastography (MRE) at Week 12
<br> - Change from Baseline of noninvasive liver fibrosis markers (Enhanced Liver Fibrosis [ELF] panel) and PRO C3 at Week 12
<br> - Change from Baseline in non-alcoholic fatty liver disease (NAFLD) Fibrosis Score (NFS), AST to Platelet Ratio Index (APRI), and fibrosis 4 (FIB-4) at Week 12
<br> - Change form Baseline in triglycerides (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), adiponectin and apolipoproteins (Apo)A1, B, C3 at Week 12
<br> - Change from Baseline in fasting glucose and insulin, homeostasis model assessment (HOMA) index (in nondiabetic subjects) and glycated hemoglobin (HbA1c) in subjects with Type 2 diabetes mellitus (T2DM) at Week 12
<br> - Change from Baseline in fibrinogen, CRP, IL6, IL1??, TNF-a, TNF-?? , alpha2 macroglobulin and haptoglobin levels at Week 12
<br> - Pharmacokinetic parameters of EDP-305 (and metabolites): Cmax, tmax, and AUClast
<br> - Change from Baseline in body weight at Week 12
<br> - Change in WTH ratio at Week 12
<br> - Pharmacodynamic parameters of EDP-305: FGF19, C4, and bile acid (BA) at Week 12<br> ;Timepoint(s) of evaluation of this end point: Week 12
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| Sponsor/Collaborators: |
Enanta Pharmaceuticals Inc.
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 2
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| Enrollment: |
125
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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: |
02/07/2018
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
10 December 2019
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| Locations: |
United States;France;Canada;Germany;New Zealand;United Kingdom
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004365-27
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