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

ClinicalTrials.gov ID: NCT03938246

Public ClinicalTrials.gov record NCT03938246. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 8, 2026, 8:13 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT03938246
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Sagimet Biosciences Inc.; Industry
Enrollment: 142 participants

Conditions and interventions

Conditions

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

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 21, 2019
Primary completion: Oct 1, 2021
Completion: Oct 1, 2021
Last update posted: Dec 18, 2024

2019 – 2021

United States locations

U.S. sites: 12
U.S. states: 4
U.S. cities: 12

Facility	City	State	ZIP	Site status
ProSciento	Chula Vista	California	91911	—
Catalina Research Institute	Montclair	California	91763	—
Clinical Trials Research	Sacramento	California	95821	—
University of California San Diego (UCSD)	San Diego	California	92037	—
Panax	Miami Lakes	Florida	33014	—
Lucas Research	Morehead City	North Carolina	28557	—
Texas Diabetes and Endocrinology - Austin	Austin	Texas	78749	—
Texas Digestive Disease Consultants - Cedar Park	Cedar Park	Texas	78613	—
Texas Digestive Disease Consultants - Dallas	Dallas	Texas	75246	—
Texas Digestive Disease Consultant - Ft Worth	Fort Worth	Texas	76104	—
Pinnacle Clinical Research - San Antonio	San Antonio	Texas	78229	—
Texas Digestive Disease Consultants - Webster	Webster	Texas	77598	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03938246, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 18, 2024 · Synced Sep 8, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03938246 live on ClinicalTrials.gov.

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