| Trial ID: | L0385 |
| Source ID: | NCT04906421
|
| Associated Drug: |
TVB-2640
|
| Title: |
A Phase 2B, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (FASCINATE-2)
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Fatty Liver Disease
|
| Interventions: |
Drug: TVB-2640;Drug: TVB-2640;Other: Placebo
|
| Outcome Measures: |
Histological reduction in nonalcoholic fatty liver disease (NAFLD) activity score (NAS) =2 points that results from reduction of necro-inflammation or improvement in liver fibrosis (by NASH Clinical Research Network [CRN] fibrosis score) at Week 52;Safety and tolerability of PO QD doses of TVB-2640 in subjects with confirmed NASH and liver fibrosis evaluated by incidence of treatment emergent adverse events (TEAEs)Proportion of subjects who achieve a 30% reduction in liver fat content as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at Week 26.
|
| Sponsor/Collaborators: |
Sagimet Biosciences Inc.
|
| Gender: |
All
|
| Age: |
18 Yearsnan
|
| Phases: |
Phase 2
|
| Enrollment: |
330
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
| Start Date: |
20/05/2021
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
21 February 2022
|
| Locations: |
United States;Canada;Poland;Puerto Rico;Canada;Poland;Puerto Rico;United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04906421
|
