clinical trial · NCT04906421
Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)
Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver DiseaseTVB-2640Placebo
brief 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.
started
Aug 12, 2021
primary completion
Oct 2, 2023
completion
Oct 2, 2023
last updated
May 9, 2025
detailed description
The indication nonalcoholic steatohepatitis \[NASH\]) is now referred to as metabolic dysfunction-associated steatohepatitis (MASH) and is characterized by hepatocyte necrosis, chronic inflammation, and resultant fibrosis formation.
official 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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol