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A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

PHASE3RECRUITING

The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.

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Study details:

This is a multi-center, open-label study of up to 700 participants with SHTG who would be rolled over from studies ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326). Day 1 of this study may be same as the Week 53 visit of either ISIS 678354-CS5 or ISIS 678354-CS6, as applicable. Participants will receive olezarsen during the 53-week treatment period.

The study will include a 31-day qualification Period, a 53-week treatment period, and a 13-week post-treatment period.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 (last dose as scheduled at Week 49) with an acceptable safety profile, per Investigator judgment.

Participants must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines.

Exclusion criteria

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-12-13

Primary completion: 2026-05-01

Study completion finish: 2026-09-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05681351

Intervention or treatment

DRUG: Olezarsen

Conditions

• Severe Hypertriglyceridemia

Image related to Severe Hypertriglyceridemia

Condition: Severe Hypertriglyceridemia
DRUG: Olezarsen
Saint Leonards, New South Wales, Australia and more
Sponsor: Ionis Pharmaceuticals, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal North Shore Hospital

Research sites nearby

Select from list below to view details:

Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, Not Specified, Australia
Royal Prince Alfred Hospital
Camperdown, Not Specified, Australia
Dr Heart Pty Ltd
Woolloongabba, Not Specified, Australia

Study Plan

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

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Olezarsen 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 49.	DRUG: Olezarsen Administered as SC injection.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53	Not Specified	Baseline up to Week 53
Proportion of Participants Who Experience Adverse Events (AEs)	Not Specified	Up to 66 weeks
Proportion of Participants Who Use Concomitant Medications	Not Specified	Up to 66 weeks

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)