At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 617 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 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 617 participants across 209 sites in 23 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hypertriglyceridemia
CountriesAustralia, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedOct 2021
Enrollment StartOct 2021
Primary CompletionOct 2024
Study CompletionJul 2025
TodayJul 2026
First PostedOct 15, 2021
Enrollment StartOct 25, 2021
Primary CompletionOct 22, 2024
Study CompletionJul 8, 2025
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 4.7 years ago
Interventions
Olezarsendrug
Olezarsen will be administered by SC injection.
Placebodrug
Olezarsen-matching placebo will be administered by SC injection.