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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04177680 | Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia | PHASE2 | COMPLETED | 100 | — | — | Jun 3, 2020 | Jan 18, 2021 | Mar 4, 2022 | 8 | United States |
Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population
| Arm | Type | Description |
|---|---|---|
| Omega-3 pentaenoic acid (MAT9001) | EXPERIMENTAL | 2g MAT9001 capsules twice daily with meals |
| Icosapent ethyl (Vascepa) | ACTIVE_COMPARATOR | 2g Vascepa capsules twice daily with meals |
| Name | Type | Description |
|---|---|---|
| Omega 3 pentaenoic acid | DRUG | Encapsulated omega-3 pentaenoic acid |
| icosapent ethyl | DRUG | Encapsulated omega-3 acid ethyl esters |
Inclusion Criteria: * Male or female, ≥18 y of age * Judged to be in generally good health * Fasting triglycerides ≥150 mg/dL to ≤499 mg/dL during screening * Body mass index of ≥20.0 kg/m2 * No clinically significant findings in a 12-lead ECG or physical examination * Willing and able to undergo t...