A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients With Severe Hypertriglyceridemia
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients With Severe Hypertriglyceridemia
The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.
This is a multi-center, randomized, double-blind, placebo-controlled study in 617 participants. Participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. The length of participation in the study will be approximately 78 weeks, which includes an up to 12-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.
Key Inclusion Criteria:
Key Exclusion Criteria:
Ann Arbor, Michigan 48109, United States
Charlotte, North Carolina 28204, United States
Saint Leonards, New South Wales 2065, Australia
Clayton S., Victoria 3168, Australia
Roma, 00168, Italy
Łódz, 93-338, Poland
Porto, 4200-319, Portugal
Barcelona, 8208, Spain