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Familial Chylomicronemia Syndrome| Olezarsen

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A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)

This is a multi-center, open-label extension (OLE) study of up to 60 participants with FCS rolling-over from Study ISIS 678354-CS3 (NCT04568434). Participants will receive olezarsen during a 53-week treatment period, followed by a 13-week post-treatment follow-up period. The length of participation in this study is approximately 70 weeks, which includes an up to 31-day qualification period, a 53-week treatment period, and a 13-week post-treatment evaluation period.

Purpose of Study

The purpose of this study is to evaluate the effect of olezarsen (formerly known as AKCEA-APOCIII-LRx) on the percent change in fasting triglycerides (TG) from baseline.

Eligibility

Age:
18 +
Sex:
Female Icon + Male Icon

Key Inclusion / Exclusion Criteria

Inclusion Criteria:

  • • Satisfactory completion of treatment with olezarsen in the index study (ISIS 678354-CS3, last dose as scheduled at Week 49) with an acceptable safety profile, per Investigator judgement.

Exclusion Criteria:

  • • Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the patient participating in or completing the study, including need for treatment with medications disallowed in the index study (ISIS 678354-CS3).

Conditions:

Familial Chylomicronemia Syndrome

Status:

Recruiting

Phase:

Phase 3

Clinical Trials ID

NCT05130450

Read Detailed Summary:

Start Date / End Date:

11 2021 - 04 2025

Intervention:

Olezarsen

Enrollment:

60

Full Details:

https://clinicaltrials.gov/ct2/show/NCT05130450