Severe hypertriglyceridemia (SHTG)
Conditions
Brief summary
Percent change in fasting serum TG levels from baseline to Month 12 (V10 and V11) compared to placebo
Detailed description
Percent change in fasting serum TG levels from baseline to Month 10 (V8 and V9) compared to placebo, Proportion of subjects who achieve fasting TG levels of <500 mg/dL (<5.65 mmol/L) at Month 12 (V10 and V11) compared to placebo, Proportion of subjects who achieve fasting TG levels of <150 mg/dL (<1.69 mmol/L) at Month 12 (V10 and V11) compared to placebo, Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 (V11) compared to placebo, Percent change in non-HDL-C from baseline to Month 12 (V11) compared to placebo, Adjudicated AP event rate during the treatment period compared to placebo from day 1 to at Month 12 (V11)
Interventions
Sponsors
Arrowhead Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in fasting serum TG levels from baseline to Month 12 (V10 and V11) compared to placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in fasting serum TG levels from baseline to Month 10 (V8 and V9) compared to placebo, Proportion of subjects who achieve fasting TG levels of <500 mg/dL (<5.65 mmol/L) at Month 12 (V10 and V11) compared to placebo, Proportion of subjects who achieve fasting TG levels of <150 mg/dL (<1.69 mmol/L) at Month 12 (V10 and V11) compared to placebo, Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 (V11) compared to placebo, Percent change in non-HDL-C from baseline to Month 12 (V11) compared to placebo, Adjudicated AP event rate during the treatment period compared to placebo from day 1 to at Month 12 (V11) | — |
Countries
Belgium, Bulgaria, Croatia, Czechia, Hungary, Italy, Poland, Romania, Slovakia, Spain
Outcome results
None listed