| Trial ID: | L0468 |
| Source ID: | NCT03938246
|
| Associated Drug: |
TVB-2640
|
| Title: |
A Phase 2, Multi-Center, Single-Blind, Randomized, Placebo-Controlled Study of TVB 2640 in Subjects With Non-Alcoholic Steatohepatitis (FASCINATE-1)
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-Alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: TVB-2640;Other: Placebo
|
| Outcome Measures: |
The effect of TVB-2640 versus placebo on the change in hepatic fat fraction from baseline in subjects with NASH by proton-density fat fraction by magnetic resonance imaging.;The safety of TVB-2640 versus placebo in subjects with NASH, including changes in liver enzymes by monitoring adverse events.The effect of TVB-2640 versus placebo on the change in triglycerides from baseline in subjects with NASH.;The effect of TVB-2640 versus placebo on the change in low-density lipoprotein cholesterol (LDL-C) from baseline in subjects with NASH.;The effect of TVB-2640 versus placebo on the change in high-density lipoprotein cholesterol (HDL-C) from baseline in subjects with NASH.;The effect of TVB-2640 versus placebo on the change in total cholesterol from baseline in subjects with NASH.;The effect of TVB-2640 versus placebo on the change in NASH and cytokeratin-18 (CK-18) from baseline in subjects with NASH.;The effect of TVB-2640 versus placebo on the change in NASH and fibrosis-4 (FIB-4) from baseline in subjects with NASH.;The effect of TVB-2640 versus placebo on the change in NASH and enhanced liver fibrosis score (ELF) from baseline in subjects with NASH.;The effect of TVB-2640 versus placebo on the change in levels of eicosanoids from baseline in subjects with NASH.
|
| Sponsor/Collaborators: |
Sagimet Biosciences Inc.
|
| Gender: |
All
|
| Age: |
18 Yearsnan
|
| Phases: |
Phase 2
|
| Enrollment: |
142
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
|
| Start Date: |
24/04/2019
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
8 November 2021
|
| Locations: |
United States;China;United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03938246
|
