This trial is active, not recruiting.

Condition familial chylomicronemia syndrome
Treatments volanesorsen, placebo
Phase phase 3
Sponsor Isis Pharmaceuticals
Collaborator Akcea Therapeutics
Start date August 2014
End date December 2016
Trial size 50 participants
Trial identifier NCT02211209, ISIS 304801-CS6


The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in patients with Familial Chylomicronemia Syndrome

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
300 mg volanesorsen administered subcutaneously once-weekly for 52 weeks
volanesorsen ISIS 304801
(Placebo Comparator)
Placebo administered subcutaneously once-weekly for 52 weeks

Primary Outcomes

Efficacy of ISIS-APOCIIIRx as measured by the percent change in fasting triglycerides from baseline
time frame: 13 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - History of chylomicronemia - A diagnosis of Familial Chylomicronemia Syndrome (Type 1 Hyperlipoproteinemia) - Fasting triglycerides ≥ 750 mg/dL (8.4 mmol/L) at Screening Exclusion Criteria: - Diabetes mellitus if newly diagnosed or if HbA1c ≥ 9.0% - Other types of severe hypertriglyceridemia - Active pancreatitis within 4 weeks of screening - Acute Coronary Syndrome within 6 months of screening - Major surgery within 3 months of screening - Treatment with Glybera therapy within 2 years of screening - Previous treatment with ISIS-APOCIIIRx - Have any other conditions in the opinion of the investigator which could interfere with the patient participating in or completing the study

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Isis Pharmaceuticals.