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Clinical trials
catalyst calendar across sponsors →Studies where SGMT is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
9 interventional · 2 with posted results
Held by 10 tracked-famous managers (Balyasny Asset Management L.P., MILLENNIUM MANAGEMENT LLC, HHLR ADVISORS, LTD., RENAISSANCE TECHNOLOGIES LLC, CITADEL ADVISORS LLC, +5 more) · FINRA short interest 16.3 days to cover (settled 2026-07-31) · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without AcneNCT06989840Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs)Randomized · Double-masked · Treatment | Phase 1 | Recruiting | Drug: TVB-3567, Placebo | Acne | 128 | Jan 2027 | ≤ 164 d | 2026-06-09 |
| A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 FibrosisNCT06594523Dual Primary Efficacy Endpoint 1: Interim Analysis: MASH Resolution (denifanstat 50 mg compared to placebo)Randomized · Quadruple-masked · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Business decision | Drug: Denifanstat, Placebo | MASH, NASH, Metabolic Dysfunction-associated Steatohepatitis, Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis, Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver | 0 | Dec 2030 | ≤ 1,594 d | 2025-05-15 |
| A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASHNCT06692283Primary Safety Outcome Measure: TEAEsRandomized · Double-masked · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Business decision | Drug: denifanstat, Placebo | MASLD, MASH, NASH, Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis, Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver | 0 | Jun 2026 | — | 2025-05-15 |
| A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult ParticipantsNCT07216313Area under the concentration-time curve during a dosing interval (tau) at steady state (AUC0-tau)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Denifanstat, Resmetirom | Healthy | 40 | 2025-10-20actual | — | 2026-01-23 |
| A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic FunctionNCT05835180Total TVB-2640 plasma concentration-time (AUC) at steady stateNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: TVB-2640 - 50 mg | Non-alcoholic Steatohepatitis, Hepatic Impairment, Cirrhosis | 48 | 2023-12-18actual | — | 2023-12-26 |
| Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)NCT04906421results2025-05-09Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) Without Worsening of Fibrosis (by NASH Clinical Research Network [CRN] Fibrosis Score).Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: TVB-2640 · Other: Placebo | Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease | 168 | 2023-10-02actual | — | 2025-05-09 |
| Open-label Study of the Absorption, Metabolism, and Excretion of [14C]TVB-2640 Following a Single Oral Dose in Healthy Male SubjectsNCT05657834[14C]TVB-2640: AUC-inf in plasmaOpen-label · Other | Phase 1 | Completed | Drug: [14C]-TVB-2640 | Healthy Volunteers | 8 | 2022-12-21actual | — | 2022-12-28 |
| Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH)NCT03938246results2024-12-19Percent Change in Hepatic Fat Fraction by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) From BaselineRandomized · Single-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: TVB-2640 25 mg (US), TVB-2640 50 mg (US), Placebo (US), TVB-2640 50 mg (China), Placebo (China), TVB-2640 75 mg (US) | MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis) | 142 | 2021-10-02actual | — | 2024-12-19 |
| A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid TumorsNCT02223247To determine the maximum tolerated dose (MTD) based on toxicity analysis.Open-label · Treatment | Phase 1 | Completed | Drug: TVB-2640 | Solid Malignant Tumor | 180 | Jun 2017actual | — | 2017-08-14 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19