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Recruiting NCT05681351

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

Conditions: Severe Hypertriglyceridemia

Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 700
Sponsor: Ionis Pharmaceuticals, Inc.

Location: United States

Summary

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

Eligibility 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05681351). StuddyBuddy aggregates publicly available trial information.