Hypertriglyceridemia, Cardiovascular Diseases, Atherosclerosis
Conditions
Brief summary
Percent change in fasting TG from Baseline at Week 25 compared to placebo.
Detailed description
Percent change in fasting TG from Baseline at Week 53 compared to placebo, Proportion of patients who achieve fasting TG < 150 mg/dL (1. 69 mmol/L) at Week 25 and proportion of patients who achieve fasting TG < 150 mg/dL at Week 53 compared to placebo, Percent change in fasting apoC-III, VLDL-C, remnant cholesterol, non-HDL-C, HDL-C, apoB, and LDL-C from Baseline at Week 25 and at Week 53 compared to placebo, Safety and tolerability assessments include: adverse events (AEs), vital signs and weight, physical examinations, clinical laboratory tests, electrocardiogram (ECG), and use of concomitant medications. Safety and tolerability results in patients receiving olezarsen will be compared with those receiving placebo.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in fasting TG from Baseline at Week 25 compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in fasting TG from Baseline at Week 53 compared to placebo, Proportion of patients who achieve fasting TG < 150 mg/dL (1. 69 mmol/L) at Week 25 and proportion of patients who achieve fasting TG < 150 mg/dL at Week 53 compared to placebo, Percent change in fasting apoC-III, VLDL-C, remnant cholesterol, non-HDL-C, HDL-C, apoB, and LDL-C from Baseline at Week 25 and at Week 53 compared to placebo, Safety and tolerability assessments include: adverse events (AEs), vital signs and weight, physical examinations, clinical laboratory tests, electrocardiogram (ECG), and use of concomitant medications. Safety and tolerability results in patients receiving olezarsen will be compared with those receiving placebo. | — |
Countries
Bulgaria, Czechia, Denmark, Finland, France, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Slovakia, Spain