NCT05610280

A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or With Severe Hypertriglyceridemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,478 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.

Detailed description

This is a Phase 3, multi-center, placebo-controlled study in approximately 1475 participants with hypertriglyceridemia and atherosclerotic cardiovascular disease. The study consists of 3 periods: 1) Screening Period: Week -12 to Week -1 (up to 12 weeks); 2) Treatment Period up to Week 53; and 3) Post-Treatment Follow-up Period: Week 54 to Week 66 (13 weeks). Participants enrolled will receive olezarsen or placebo once every 4 weeks during the 53-week Treatment Period. The Screening Period was extended with no impact to overall study timelines. A coronary computed tomographic angiography (CTA) sub study will be performed to assess whether triglyceride lowering through inhibition of apoC-III protein synthesis may reduce coronary plaque progression.

Conditions

• Hypertriglyceridemia
• Cardiovascular Diseases
• Atherosclerosis

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: 2022-11-21
• Primary completion: 2024-08-08
• Completion: 2025-06-09
• First posted: 2022-11-09
• Last updated: 2026-02-10

Locations

168 sites across 14 countries: United States, Bulgaria, Canada, Czechia, Denmark, France, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Slovakia, Spain

Regulatory

• FDA-regulated drug study