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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04516291 | A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70) | PHASE2 | COMPLETED | 286 | — | — | Sep 28, 2020 | Dec 6, 2021 | Oct 4, 2022 | 114 | United States, Canada +1 |
Fasting was required at least 10 hours before blood sample collection. Baseline was calculated using the average of all values obtained at Screening and on Day 1 prior to dosing.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | No drug |
| Vupanorsen 80 mg every 4 weeks | EXPERIMENTAL | 80 milligrams (mg) given subcutaneously every 4 weeks. |
| Vupanorsen 60 mg every 2 weeks | EXPERIMENTAL | 60 mg given subcutaneously every 2 weeks. |
| Vupanorsen 120 mg every 4 weeks | EXPERIMENTAL | 120 mg given subcutaneously every 4 weeks. |
| Vupanorsen 80 mg every 2 weeks | EXPERIMENTAL | 80 mg given subcutaneously every 2 weeks. |
| Vupanorsen 160 mg every 4 weeks | EXPERIMENTAL | 160 mg given subcutaneously every 4 weeks. |
| Vupanorsen 120 mg every 2 weeks | EXPERIMENTAL | 120 mg given subcutaneously every 2 weeks. |
| Vupanorsen 160 mg every 2 weeks | EXPERIMENTAL | 160 mg given subcutaneously every 2 weeks. |
| Name | Type | Description |
|---|---|---|
| Vupanorsen | DRUG | Vupanorsen and placebo will be provided as prefilled syringes packaged and dispensed in cartons with tamper-evident seals. Only single-use syringes will be used. |
| Placebo | DRUG | Vupanorsen and placebo will be provided as prefilled syringes packaged and dispensed in cartons with tamper-evident seals. Only single-use syringes will be used. |
Inclusion Criteria: 1. Male or female participants aged ≥40 years at Screening. 2. Fasting non-HDL-C at Screening ≥100 mg/dL. 3. Fasting TG at Screening of 150 to 500 mg/dL, inclusive, which may be repeated once if deemed necessary. 4. Participants must be on a stable dose of a statin for at least ...