At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 168 enrolled
Drug / intervention
TVB-2640 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating TVB-2640 and Placebo for Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease. Completed, enrolled 168 participants across 117 sites in 4 countries.
Detailed Summary
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy on TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH). Subjects will be randomly assigned toTVB-2640 or matching placebo PO QD for 52 weeks, with the first dose administered on Day 1.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Poland, Puerto Rico, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedMay 2021
Enrollment StartAug 2021
Primary CompletionOct 2023
TodayJul 2026
First PostedMay 28, 2021
Enrollment StartAug 12, 2021
Primary CompletionOct 2, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.1 years ago
Interventions
TVB-2640drug
Oral dose, tablet
Placeboother
Oral dose, tablet