At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 66 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 AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)
In Brief
A Phase 3 clinical trial evaluating Olezarsen and Placebo for Familial Chylomicronemia Syndrome. Completed, enrolled 66 participants across 47 sites in 11 countries.
Detailed Summary
The purpose of the study was 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--
ConditionsFamilial Chylomicronemia Syndrome
CountriesCanada, France, Italy, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartNov 2020
Primary CompletionJul 2023
Study CompletionOct 2023
TodayJul 2026
First PostedSep 29, 2020
Enrollment StartNov 18, 2020
Primary CompletionJul 14, 2023
Study CompletionOct 17, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.8 years ago
Interventions
Olezarsendrug
Olezarsen was administered by SC injection.
Placebodrug
Olezarsen-matching placebo was administered by SC injection.