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

NCT04906421 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-05-09

Study results available
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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.

Conditions

  • Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease

Interventions

DRUG

TVB-2640

Oral dose, tablet

OTHER

Placebo

Oral dose, tablet

Sponsors & Collaborators

  • Sagimet Biosciences Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-12
Primary Completion
2023-10-02
Completion
2023-10-02
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Poland
  • Puerto Rico

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 NCT04906421 on ClinicalTrials.gov