NCT03938246

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

A Phase 2, Multi-Center, Single-Blind, Randomized, Placebo-Controlled Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (FASCINATE-1)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Sagimet Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety and efficacy of TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH), a type of fatty liver disease. Subjects will be randomly assigned to 1 of 2 treatment groups (TVB-2640 at one of three doses or placebo). Following randomization, subjects will begin the 12-week treatment period and will receive once daily TVB-2640 or placebo.

Conditions

• MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)

Interventions

Type	Name	Description
DRUG	TVB-2640 25 mg (US)	Oral dose, tablet, daily dosing
DRUG	TVB-2640 50 mg (US)	Oral dose, tablet, daily dosing
DRUG	Placebo (US)	Oral dose, tablet, daily dosing
DRUG	TVB-2640 50 mg (China)	Oral dose, tablet, daily dosing
DRUG	Placebo (China)	Oral dose, tablet, daily dosing
DRUG	TVB-2640 75 mg (US)	Oral dose, tablet, daily dosing

Timeline

• Start date: 2019-03-22
• Primary completion: 2021-10-02
• Completion: 2021-10-02
• First posted: 2019-05-06
• Last updated: 2024-12-19
• Results posted: 2024-12-19

Locations

23 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study