7 completed, 3 recruiting, 2 withdrawn, 1 active not recruiting. 7 Phase 1, 4 Phase 2, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 5, Recruiting 2 |
| Phase 2 | 4 | Completed 3, Active not recruiting 1 |
| Phase 3 | 3 | Withdrawn 2, Recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA) Denifanstat, Placebo - Acne Vulgaris | Phase 3 | Recruiting | Sagimet Biosciences Inc. | 800 | 2026-10-01 | 2026-10-22 |
| A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants Denifanstat, Resmetirom - Healthy | Phase 1 | Completed | Sagimet Biosciences Inc. | 40 | 2025-09-30 | 2026-01-23 |
| Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne TVB-3567, Placebo - Acne | Phase 1 | Recruiting | Sagimet Biosciences Inc. | 152 | 2025-06-03 | 2026-10-21 |
| A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis Denifanstat, Placebo - MASH, NASH | Phase 3 | Withdrawn | Sagimet Biosciences Inc. | 2025-03-01 | 2025-05-15 | |
| A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH denifanstat, Placebo - MASLD, MASH | Phase 3 | Withdrawn | Sagimet Biosciences Inc. | 2025-03-01 | 2025-05-15 | |
| Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer TVB-2640, Enzalutamide - Prostatic Neoplasms, Castration-Resistant | Phase 1 | Recruiting | Weill Medical College of Cornell University | 30 | 2023-11-20 | 2025-11-21 |
| A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function TVB-2640 - 50 mg - Non-alcoholic Steatohepatitis, Hepatic Impairment | Phase 1 | Completed | Sagimet Biosciences Inc. | 48 | 2023-05-01 | 2023-12-26 |
| Open-label Study of the Absorption, Metabolism, and Excretion of [14C]TVB-2640 Following a Single Oral Dose in Healthy Male Subjects [14C]-TVB-2640 - Healthy Volunteers | Phase 1 | Completed | Sagimet Biosciences Inc. | 8 | 2022-11-21 | 2022-12-28 |
| Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH) TVB-2640, Placebo - Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease | Phase 2 | Completed | Sagimet Biosciences Inc. | 168 | 2021-08-12 | 2025-05-09 |
| Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas TVB-2640 - KRAS Gene Mutation | Phase 2 | Active not recruiting | David E Gerber | 18 | 2019-09-11 | 2026-05-22 |
| Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH) TVB-2640 25 mg (US), TVB-2640 50 mg (US), Placebo (US) - MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis) | Phase 2 | Completed | Sagimet Biosciences Inc. | 142 | 2019-03-22 | 2024-12-19 |
| Evaluation of 3-V Bioscience-2640 to Reduce de Novo Lipogenesis in Subjects With Characteristics of Metabolic Syndrome 3-V Bioscience-2640 - Metabolic Syndrome | Phase 1 / Phase 2 | Completed | University of Missouri-Columbia | 12 | 2017-02-01 | 2025-05-04 |
| A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors TVB-2640 - Solid Malignant Tumor | Phase 1 | Completed | Sagimet Biosciences Inc. | 180 | 2013-11-01 | 2017-08-14 |
Non-alcoholic Fatty Liver Disease (5) · Fatty Liver (4) · Acne Vulgaris (2) · Fibrosis (2) · Liver Diseases (2) · Digestive System Diseases (1) · Hyperlipidemias (1) · Hypertension (1) · Insulin Resistance (1) · Metabolic Syndrome (1) · Neoplasms (1) · Obesity (1) · Prostatic Neoplasms, Castration-Resistant (1)
TVB-2640 (8) · enzalutamide (1) · resmetirom (1)
United States (11) · Australia (1) · Canada (1) · China (1) · Hungary (1) · Poland (1) · Puerto Rico (1) · United Kingdom (1)
David Gerber, MD (1) · David Nanus, M.D. (1) · Elizabeth J Parks, PhD (1) · Jeffrey R Infante, MD (1) · Rohit Loomba, MD (1)