Suspended

Olezarsen for Severe Hypertriglyceridemia

Study Aim

This study aims to evaluate the safety and effects of Olezarsen in reducing triglyceride levels and monitoring health changes in people with severe hypertriglyceridemia over a period of up to 157 weeks.

What is being tested

Olezarsen

Drug

Who is being recruted

Hyperlipidemias+3

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

Over 18 Years

+4 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: December 2022

See protocol details

Summary

Principal SponsorIonis Pharmaceuticals, Inc.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 13, 2022

Actual date on which the first participant was enrolled.

This clinical trial is focused on testing a medication called olezarsen in patients with severe hypertriglyceridemia (SHTG), a condition where there are very high levels of triglycerides in the blood. The study is an extension of previous trials, and it is designed to involve around 800 participants who have already been part of earlier studies. The aim is to further evaluate the effectiveness and safety of olezarsen in managing SHTG. This study is important because high triglyceride levels can lead to serious health issues like pancreatitis, and finding an effective treatment could significantly improve the quality of life for those affected. The study involves a 157-week treatment period where participants receive olezarsen through injections under the skin. Before starting the treatment, there is a 31-day qualification period to ensure participants meet the study requirements. After the treatment period, there is a 13-week follow-up phase. Researchers will monitor participants to see if they experience any adverse events, need additional medications, or show changes in laboratory test results over the study period. By closely observing these factors, the study aims to provide comprehensive information about the long-term effects and safety of olezarsen treatment for individuals with SHTG.

Official TitleAn Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG)

NCT05681351

Principal SponsorIonis Pharmaceuticals, Inc.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

885 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperlipidemiasMetabolic DiseasesNutritional and Metabolic DiseasesHypertriglyceridemiaDyslipidemiasLipid Metabolism Disorders

Criteria

3 inclusion criteria required to participate

Participants must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. A patient may be eligible if their regimen of lipid-lowering therapy has been changed recently, provided that lipid lowering medications are optimized and stabilized for at least 4 weeks prior to the end of the Qualification Period of this OLE study; ideally, such changes are initiated after Week 53 of the index study (ISIS 678354-CS5 or CS6).

Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 with an acceptable safety profile, per Investigator judgment. Satisfactory completion requires that the patient did not terminate early from treatment.

A patient may re-enroll in the study after having completed the study when the Treatment Period was 53 weeks, if the patient satisfactorily completed the study with an acceptable safety profile, per Investigator judgment. In the case of re-enrollment, there is no limit on the time gap between completion of treatment under the previous protocol and dosing upon re-enrollment (i.e., may exceed 17 weeks between doses).

1 exclusion criteria prevent from participating

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. It is acceptable to adjust a regimen of lipid-lowering therapy as described in the second Key Inclusion Criterion above, and it is acceptable to adjust or stop lipid-lowering therapy at or after Week 13 per Investigator judgment.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants who completed either ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326) study would be enrolled to receive olezarsen, subcutaneous (SC) injection, once every 4 weeks from Week 1 through Week 153.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 262 locations

Suspended

Instituto Medico DAMIC

Córdoba, ArgentinaOpen Instituto Medico DAMIC in Google Maps

Suspended

Clinica FUSAVIM Privada

Villa María, Argentina

Suspended

Royal North Shore Hospital

Saint Leonards, Australia

Suspended

Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD

Sofia, Bulgaria

Suspended262 Study Centers