denifanstat
denifanstat: 7 clinical trials tracked.
denifanstat evidence translation
What we can confirm
7 tracked trials
What it means
What to watch
Prepared research question
What is verified about denifanstat, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 1 study sponsors
Related indications
Study sponsors
Clinical Trial Registry Records (7)
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Design Trial to Evaluate the Safety and Efficacy of Denifanstat in Participants With Moderate to Severe Acne Vulgaris
Primary endpoint: Proportion of participants achieving EGSS success, defined as a score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from their baseline score
A Phase 1, Open-Label Study to Evaluate the Mutual Drug-Drug Interaction Potential Between Denifanstat and Resmetirom in Healthy Adult Participants
Primary endpoint: Area under the concentration-time curve during a dosing interval (tau) at steady state (AUC0-tau)
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Denifanstat in Patients With Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis (MASH) and F2/F3 Fibrosis (FASCINATE-3)
Primary endpoint: Dual Primary Efficacy Endpoint 1: Interim Analysis: MASH Resolution (denifanstat 50 mg compared to placebo)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Denifanstat in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MALSD)/Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Primary endpoint: Primary Safety Outcome Measure: TEAEs
A Phase I, Open-Label, Dose-Finding Study of TVB-2640 Administered in Combination With Enzalutamide (Xtandi) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Primary endpoint: Optimal dose of TVB-2640 in combination with Enzalutamide, as determined by the maximum tolerated dose (MTD)
A Phase 2B, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (FASCINATE-2)
Primary endpoint: Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) Without Worsening of Fibrosis (by NASH Clinical Research Network [CRN] Fibrosis Score).
A Phase 2 Multi-center Pharmacodynamics Study of TVB-2640 in KRAS Mutant Non-small Cell Lung Carcinomas
Primary endpoint: Disease Control Rate of TVB-2640