NCT05552326

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

Detailed description

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study in 446 participants. Participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. The length of participation in the study will be approximately 78 weeks, which includes an up to 12-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.

Conditions

• Severe Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	Olezarsen	Olezarsen will be administered by SC injection.
DRUG	Placebo	Olezarsen-matching placebo will be administered by SC injection.

Timeline

• Start date: 2022-08-31
• Primary completion: 2024-12-17
• Completion: 2025-09-12
• First posted: 2022-09-23
• Last updated: 2025-10-22

Locations

205 sites across 23 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Greece, Hungary, India, Italy, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Taiwan

Regulatory

• FDA-regulated drug study