| Trial ID: | L0567 |
| Source ID: | NCT02941549
|
| Associated Drug: |
DS102
|
| Title: |
A Randomised, Double-Blind, Placebo-Controlled, Exploratory Phase IIa Study To Assess The Safety And Efficacy Of Orally Administered DS102 In NAFLD Patients.
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non Alcoholic Fatty Liver Disease
|
| Interventions: |
Other: Placebo capsules;Drug: DS102
|
| Outcome Measures: |
Change in serum ALT (alanine aminotransferase) from baseline to week 16;Change in liver stiffness measurements by Transient Elastography from baseline to week 16;Number of Treatment Emergent Adverse Events (TEAEs) in each treatment group leading to discontinuationChange in serum ALT (alanine aminotransferase) from baseline to weeks 2, 4, 8 and 12;Change in AST (aspartate aminotransferase) from baseline to weeks 2, 4, 8, 12 and 16;Change in AST:ALT ratio from baseline to weeks 2, 4, 8, 12 and 16;Change in FIB-4 from baseline to week 16;Change in NAFLD fibrosis score (NFS) from baseline to week 16;Change in hepatic fat measured by CAP (controlled attenuation parameter) from baseline to week 16;Change in ELF (Enhanced Liver Fibrosis score) from baseline to week 16;Change in HOMA-IR/Adipo-IR (Homeostatic Model Assessment Insulin
|
| Sponsor/Collaborators: |
Afimmune
|
| Gender: |
All
|
| Age: |
18 Years75 Years
|
| Phases: |
Phase 2
|
| Enrollment: |
96
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
| Start Date: |
20/10/2016
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
12 December 2020
|
| Locations: |
Georgia;Ukraine;United Kingdom;Georgia;Ukraine;United Kingdom;Spain
|
| URL: |
https://clinicaltrials.gov/show/NCT02941549
|
