NCT04906421Phase 2Completed

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

Study sponsor: Sagimet Biosciences Inc. · SGMT

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-10-02Actual

Enrollment · participants168Actual

Source updated2025-05-09Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease

Treatments or interventions studied

TVB-2640Drug

Primary outcomes · main study measures

Read the study measures

measure: Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) Without Worsening of Fibrosis (by NASH Clinical Research Network [CRN] Fibrosis Score).; description: Histological improvement is defined as ≥2 points improvement in NAS with ≥1 point improvement in ballooning or inflammation; timeFrame: 52 Weeks; measure: Subjects With Resolution of Steatohepatitis and No Worsening of Liver Fibrosis by NASH CRN Fibrosis Score and Histological Improvement in NAS.; description: NASH resolution defined as absence of fatty liver disease or isolated or simple steatosis without steatohepatitis and a score of either 0 or 1 for inflammation, 0 for ballooning and any value for steatosis and no worsening of liver fibrosis (by NASH CRN fibrosis score). Histological improvement defined as ≥2 point improvement in NAS (with ≥1 point improvement in ballooning or inflammation).; timeFrame: 52 Weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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