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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02927184 | Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease | PHASE2 | COMPLETED | 59 | — | — | Sep 28, 2016 | Mar 26, 2019 | Apr 26, 2021 | 19 | United States |
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo capsule |
| VK2809 (5mg) | EXPERIMENTAL | 5mg VK2809 capsule |
| VK2809 (10mg) | EXPERIMENTAL | 10mg VK2809 capsule |
| VK2809 (10mg QOD) | EXPERIMENTAL | 10mg VK2809 capsule |
| Name | Type | Description |
|---|---|---|
| VK2809 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Minimum of 10% liver fat as assessed by MRI - Proton Density Fat Fraction 2. Fasting serum LDL-C \>130 mg/dL at screening, \>110 mg/dL on lipid lowering medications 3. Any one of the following: 1. Triglycerides ≥150 mg/dL or receiving prescription medication for elevated ...