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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03385239 | Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD) | PHASE2 | COMPLETED | 114 | — | — | Jan 30, 2018 | Feb 25, 2020 | Jan 11, 2023 | 31 | United States, Canada |
An analysis of covariance (ANCOVA) model was performed on the log ratio of TG value at the Primary Analysis Time Point to TG value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: (ratio of TG value at the Primary Analysis Time Point to TG value at Baseline - 1) × 100.
An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically-significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered to be related to the investigational drug product. A TEAE was defined as any AE starting on or after the first dose of the study drug.
| Arm | Type | Description |
|---|---|---|
| Pooled Placebo | PLACEBO_COMPARATOR | Participants in each cohort (A, B, C and D) were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354). |
| Cohort A: ISIS 678354: 10 mg Q4W | EXPERIMENTAL | Cohort A participants received 10 milligrams (mg) ISIS 678354, subcutaneous (SC) injection, once every 4 weeks (Q4W), for up to 49 weeks and a maximum of 13 doses. |
| Cohort C: ISIS 678354: 15 mg Q2W | EXPERIMENTAL | Cohort C participants received 15 mg ISIS 678354, SC injection, once every 2 weeks (Q2W) for up to 51 weeks and a maximum of 26 doses. |
| Cohort D: ISIS 678354: 10 mg QW | EXPERIMENTAL | Cohort D participants received 10 mg ISIS 678354, SC injection, once weekly (QW) for up to 52 weeks and a maximum of 52 doses. |
| Cohort B: ISIS 678354: 50 mg Q4W | PLACEBO_COMPARATOR | Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses. |
| Name | Type | Description |
|---|---|---|
| ISIS 678354 | DRUG | ISIS 678354 solution for SC injection. |
| Placebo | DRUG | Sterile Normal Saline (0.9% NaCl). |
Key Inclusion Criteria: * Clinical diagnosis of CVD (defined as documented coronary artery disease, stroke, or peripheral artery disease). * Fasting serum triglycerides (TG) greater than or equal to (≥) 200 milligrams per deciliter (mg/dL) (≥ 2.3 millimoles per liter (mmol/L)) and less than or equa...