Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04906421 | Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH) | PHASE2 | COMPLETED | 168 | — | — | Aug 12, 2021 | Oct 2, 2023 | May 9, 2025 | 117 | United States, Canada +2 |
Histological improvement is defined as ≥2 points improvement in NAS with ≥1 point improvement in ballooning or inflammation
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).
| Arm | Type | Description |
|---|---|---|
| TVB-2640 50 mg | EXPERIMENTAL | Subjects will receive TVB-2640 PO QD for 52 weeks, with the first dose administered on Day 1. |
| Placebo | PLACEBO_COMPARATOR | Subjects will receive matching placebo PO QD for 52 weeks, with the first dose administered on Day 1. |
| Name | Type | Description |
|---|---|---|
| TVB-2640 | DRUG | Oral dose, tablet |
| Placebo | OTHER | Oral dose, tablet |
Inclusion Criteria: * Must be willing and able to participate in the study and provide written informed consent. * Male and female adults ≥18 years of age on the date that written informed consent to take part in the study is provided. * Body mass index (BMI) ≥23 kg/m2 for Asians and ≥25 kg/m2 for ...