Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ISIS 678354 · 1 trial · 2 indications
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...
ISIS 678354 is an investigational drug being developed for the treatment of hypertriglyceridemia, a condition characterized by elevated levels of triglycerides in the blood. It is being studied in patients with hypertriglyceridemia and established cardiovascular disease. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
ISIS 678354 is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for hypertriglyceridemia.
ISIS 678354 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of hypertriglyceridemia in patients with established cardiovascular disease.
ISIS 678354 has been studied in one completed Phase 2 clinical trial with the identifier NCT03385239. This randomized, double-blind, placebo-controlled trial enrolled 114 participants with hypertriglyceridemia and established cardiovascular disease. The study was conducted in the United States and Canada.
Yes, ISIS 678354 is also known as AKCEA-APOCIII-LRx. The clinical trial NCT03385239, which studied ISIS 678354 in participants with hypertriglyceridemia and established cardiovascular disease, refers to the drug as AKCEA-APOCIII-LRx in its title.