Overview

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

Status:
Recruiting

Trial end date:
2026-09-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Ionis Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

- 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.

- Participants must be on a stable regimen of lipid-lowering therapy that should adhere
to standard of care (SOC) per local guidelines.

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 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.