CompletedPhase 2

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

United States142 participantsStarted 2019-03-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Aged ≥ 18 years with a body mass index (BMI) ≤40 kg/m2.
✓. Prior liver biopsy within 24 months of randomization with fibrosis Stage 1 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:

Exclusion criteria

✕. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening.
✕. Type 1 diabetes.
✕. Uncontrolled Type 2 diabetes defined as:
✕. Presence of cirrhosis on liver biopsy (Stage 4 fibrosis) or imaging.

What they're measuring

Percent Change in Hepatic Fat Fraction by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) From Baseline

Timeframe: 12 weeks

Trial details

NCT IDNCT03938246

SponsorSagimet Biosciences Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-02

Results submitted2024-11-21

View on ClinicalTrials.gov More MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis) trials