At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 446 enrolled
Drug / intervention
Olezarsen +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia
In Brief
A Phase 3 clinical trial evaluating Olezarsen and Placebo for Severe Hypertriglyceridemia. Completed, enrolled 446 participants across 205 sites in 23 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hypertriglyceridemia
CountriesArgentina, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Greece, Hungary, India, Italy, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
Enrollment StartAug 2022
First PostedSep 2022
Primary CompletionDec 2024
Study CompletionSep 2025
TodayJul 2026
First PostedSep 23, 2022
Enrollment StartAug 31, 2022
Primary CompletionDec 17, 2024
Study CompletionSep 12, 2025
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 3.8 years ago
Interventions
Olezarsendrug
Olezarsen will be administered by SC injection.
Placebodrug
Olezarsen-matching placebo will be administered by SC injection.