NCT04906421

Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Sagimet Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	TVB-2640	Oral dose, tablet
OTHER	Placebo	Oral dose, tablet

Timeline

• Start date: 2021-08-12
• Primary completion: 2023-10-02
• Completion: 2023-10-02
• First posted: 2021-05-28
• Last updated: 2025-05-09
• Results posted: 2025-05-09

Locations

117 sites across 4 countries: United States, Canada, Poland, Puerto Rico

Regulatory

• FDA-regulated drug study