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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

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT05681351

    Intervention or treatment

    DRUG: Olezarsen

    Conditions

    • Severe Hypertriglyceridemia

    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

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    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/ArmIntervention/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 MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53Not SpecifiedBaseline up to Week 53
    Proportion of Participants Who Experience Adverse Events (AEs)Not SpecifiedUp to 66 weeks
    Proportion of Participants Who Use Concomitant MedicationsNot SpecifiedUp to 66 weeks

    Secondary outcome

    Frequently Asked Questions

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    References

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

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