Olezarsen for High Triglycerides

Recruiting in Palo Alto (17 mi)

+205 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Ionis Pharmaceuticals, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called olezarsen to see if it can lower blood fat levels in people with high triglycerides. The goal is to find out if olezarsen can effectively reduce triglycerides and help prevent related health issues. Olezarsen has been shown to significantly reduce apoC-III, triglycerides, and atherogenic lipoproteins in patients with moderate hypertriglyceridaemia and at high risk for or with established cardiovascular disease.

Research Team

Eligibility Criteria

This trial is for people with severe hypertriglyceridemia, having fasting triglycerides of 500 mg/dL or higher. Participants should be on a stable lipid-lowering therapy for at least 4 weeks and willing to follow diet and lifestyle advice. Those with certain liver, kidney, or blood sugar conditions are excluded.

Inclusion Criteria

I have been on stable cholesterol-lowering medication for at least 4 weeks.

Participants must be willing to comply with diet and lifestyle recommendations as able.

Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification

Exclusion Criteria

Total bilirubin > 1.5 ULN unless due to Gilbert's syndrome

My kidney function is severely reduced.

Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal

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Treatment Details

Interventions

Olezarsen (Antisense Oligonucleotide)
Placebo (Other)

Trial OverviewThe study tests the effectiveness of Olezarsen in reducing fasting triglyceride levels compared to a placebo. Participants will receive either Olezarsen or a placebo injection and their change in triglyceride levels from the start of the study will be measured.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OlezarsenExperimental Treatment1 Intervention

Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.

Group II: PlaceboPlacebo Group1 Intervention

Olezarsen-matching placebo will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.