ISIS 678354-CS6 A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients with Severe Hypertriglyceridemia

Conditions

Severe hypertryglyceridemia

Brief summary

Percent Change from Baseline in Fasting TG Compared to Placebo [Time Frame: Baseline and Month 6]

Detailed description

Percent Change from Baseline in Fasting TG Compared to Placebo [Time Frame: Baseline and Month 12], Percent Change from Baseline in Fasting Apolipoprotein C-III (ApoC-III), Remnant Cholesterol and Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Compared to Placebo [Time Frame: Baseline, Month 6 and 12], Proportion of Patients who Achieve Fasting TG <500 mg/dL (5.65 mmol/L) Compared to Placebo [Time Frame: Month 12], Proportion of Patients Who Achieve Fasting TG < 880 mg/dL (10 mmol/L) Compared to Placebo in the Subgroup of Patients with Baseline TG ≥ 880 mg/dL [Time Frame: Month 12], Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo [Time Frame: Week 1 through Week 53], Absolute Change in Hepatic Fat Fraction (HFF) Between Olezarsen Treatment Group and Placebo

Related papers

No related papers found yet.

Interventions

DRUGISIS 678354

DRUGPlacebo Injection

DRUG0.8 mL is a sterile

DRUGpreservative-free

DRUGparenteral solution of sodium chloride and riboflavin in water for injection (WFI) intended for subcutaneous injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent Change from Baseline in Fasting TG Compared to Placebo [Time Frame: Baseline and Month 6]	—

Secondary

Measure	Time frame
Percent Change from Baseline in Fasting TG Compared to Placebo [Time Frame: Baseline and Month 12], Percent Change from Baseline in Fasting Apolipoprotein C-III (ApoC-III), Remnant Cholesterol and Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Compared to Placebo [Time Frame: Baseline, Month 6 and 12], Proportion of Patients who Achieve Fasting TG <500 mg/dL (5.65 mmol/L) Compared to Placebo [Time Frame: Month 12], Proportion of Patients Who Achieve Fasting TG < 880 mg/dL (10 mmol/L) Compared to Placebo in the Subgroup of Patients with Baseline TG ≥ 880 mg/dL [Time Frame: Month 12], Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo [Time Frame: Week 1 through Week 53], Absolute Change in Hepatic Fat Fraction (HFF) Between Olezarsen Treatment Group and Placebo	—

Measure

Time frame

Percent Change from Baseline in Fasting TG Compared to Placebo [Time Frame: Baseline and Month 12], Percent Change from Baseline in Fasting Apolipoprotein C-III (ApoC-III), Remnant Cholesterol and Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Compared to Placebo [Time Frame: Baseline, Month 6 and 12], Proportion of Patients who Achieve Fasting TG <500 mg/dL (5.65 mmol/L) Compared to Placebo [Time Frame: Month 12], Proportion of Patients Who Achieve Fasting TG < 880 mg/dL (10 mmol/L) Compared to Placebo in the Subgroup of Patients with Baseline TG ≥ 880 mg/dL [Time Frame: Month 12], Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo [Time Frame: Week 1 through Week 53], Absolute Change in Hepatic Fat Fraction (HFF) Between Olezarsen Treatment Group and Placebo

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Countries

Belgium, Bulgaria, Czechia, France, Greece, Hungary, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden

Outcome results

None listed