At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,478 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) in Patients With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or With Severe Hypertriglyceridemia
In Brief
A Phase 3 clinical trial evaluating Olezarsen and Placebo for Hypertriglyceridemia and 2 related conditions. Completed, enrolled 1,478 participants across 168 sites in 14 countries.
Detailed Summary
The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Canada, Czechia, Denmark, France, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedNov 2022
Enrollment StartNov 2022
Primary CompletionAug 2024
Study CompletionJun 2025
TodayJul 2026
First PostedNov 9, 2022
Enrollment StartNov 21, 2022
Primary CompletionAug 8, 2024
Study CompletionJun 9, 2025
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 3.6 years ago
Interventions
Olezarsendrug
Olezarsen will be administered by SC injection.
Placebodrug
Olezarsen-matching placebo will be administered by SC injection.