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A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT05552326•Ionis Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
•2. Participants must be on lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to screening to minimize changes in these medications during the study.
•3. Participants must be willing to comply with diet and lifestyle recommendations as able.

Exclusion Criteria

•1. Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
•2. Alanine aminotransferase or aspartate aminotransferase \> 3.0 × upper limit of normal
•3. Total bilirubin \> 1.5 ULN unless due to Gilbert's syndrome
•4. Estimated GFR \< 30 mL/min/1.73 m\^2

Locations (205)

Central Research Associates, Inc.

Birmingham, Alabama, United States

Alabama Clinical Therapeutics, LLC Alabaster

Birmingham, Alabama, United States

Onyx Clinical Research

Peoria, Arizona, United States

NRC Research Institute

Los Angeles, California, United States

Accel Research Sites

DeLand, Florida, United States

Finlay Medical Research

Greenacres City, Florida, United States

University of Florida Jacksonville

Jacksonville, Florida, United States

Meridien Research

Maitland, Florida, United States

Columbus Clinical Services

Miami, Florida, United States

Harmony Clinical Research, Inc

North Miami Beach, Florida, United States

Key Dates

Start Date

August 31, 2022

Primary Completion Date

December 17, 2024

Completion Date

September 12, 2025

Last Updated

October 22, 2025

Enrollment

446

ACTUAL participants

Conditions

Severe Hypertriglyceridemia

Interventions

Olezarsen

DRUG

Placebo

DRUG

Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis

NCT03452228

Severe Hypertriglyceridemia (sHTG)

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WITHDRAWNPHASE3

The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL)

NCT01997268

Severe Hypertriglyceridemia

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COMPLETEDPHASE2/PHASE3

Epanova® for Lowering Very High Triglycerides

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.