CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

a study on Hypertriglyceridemia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

Summary

The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.

Official Title

An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG)

Details

This is a multi-center, open-label study of up to 800 participants with SHTG who would be rolled over from studies ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326). Day 1 of this study may be same as the Week 53 visit of either ISIS 678354-CS5 or ISIS 678354-CS6, as applicable. Participants will receive olezarsen during the 53-week treatment period. The study will include a 31-day qualification Period, a 53-week treatment period, and a 13-week post-treatment period.

Keywords

Severe Hypertriglyceridemia, ISIS 678354, Olezarsen, Hypertriglyceridemia

Eligibility

You can join if…

Open to people ages 18 years and up

  • Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 (last dose as scheduled at Week 49) with an acceptable safety profile, per Investigator judgment. Satisfactory completion requires that the patient did not terminate early from treatment.
  • Participants must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines.

You CAN'T join if...

  • 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 participant participating in or completing the study, including need for treatment with disallowed medications, or need to change the required stable regimen as per either ISIS 678354-CS5 or ISIS 678354-CS6 study entry criteria.

NOTE: Other Inclusion/Exclusion criteria may apply.

Locations

  • University of California, San Diego (UCSD) accepting new patients
    San Diego California 92161 United States
  • Metabolic Institute of America accepting new patients
    Tarzana California 91356 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ionis Pharmaceuticals, Inc.
ID
NCT05681351
Phase
Phase 3 Hypertriglyceridemia Research Study
Study Type
Interventional
Participants
Expecting 800 study participants
Last Updated