A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH
← catalyst calendarSponsored by Sagimet Biosciences Inc. (industry) · SGMT — their whole pipeline →.
Phase
Phase 3
Status
Withdrawn
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
0actual
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Business decision
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Mar 2025 | estimated | When the study began enrolling |
| Primary completion | Jun 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2024-11-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-05-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- MASLD
- MASH
- NASH
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- Metabolic Dysfunction-Associated Steatohepatitis
- Nonalcoholic Steatohepatitis
- Nonalcoholic Fatty Liver
Interventions
- Drug: denifanstat — also filed as TVB-2640
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFPrimary Safety Outcome Measure: TEAEs
measured 52 weeks
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