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

NCT03938246 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2024-12-19

Study results available
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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

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

Sponsors & Collaborators

  • Sagimet Biosciences Inc.

    lead INDUSTRY

Principal Investigators

  • Rohit Loomba, MD · UCSD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-22
Primary Completion
2021-10-02
Completion
2021-10-02
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03938246 on ClinicalTrials.gov