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Clinical Trials List

Protocol NumberISIS 678354-CS6
NCT Number(ClinicalTrials.gov Identfier)NCT05681351
Completed

2023-02-01 - 2025-12-31

Phase III

Recruiting7

ICD-10E78.1

Pure hyperglyceridemia

ICD-9272.1

Pure hyperglyceridemia

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

  • Trial Applicant

    MEDPACE TAIWAN LIMITED

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Hung-I Yeh Division of Cardiovascular Diseases
MacKay Memorial Hospital

Co-Principal Investigator

  • 李俊偉 Division of Cardiovascular Diseases
  • 洪崇烈 Division of Cardiovascular Diseases
  • 程崇偉 Division of Cardiovascular Diseases
  • 蘇正煌 Division of Cardiovascular Diseases
  • 李應湘 Division of Cardiovascular Diseases
  • 郭任遠 Division of Cardiovascular Diseases
  • 廖峰慶 Division of Cardiovascular Diseases
  • 林書毅 Division of Cardiovascular Diseases
  • 陳俊延 Division of Cardiovascular Diseases
  • 劉俊傑 Division of Cardiovascular Diseases
  • 吳懿哲 Division of Cardiovascular Diseases
  • 洪大川 Division of Cardiovascular Diseases
  • 陳律安 Division of Neurology
  • 簡禎彥 Division of Cardiovascular Diseases
  • 林肇鋒 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-Chang Hsieh Division of Cardiovascular Diseases
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator JUN-SING WANG Division of Endocrinology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Min-Ji Charng Division of Cardiovascular Diseases
Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Heng Li Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-I Yeh 無
馬偕紀念醫院佳生臨床藥理試驗中心_佳永生技股份有限公司

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Severe Hypertriglyceridemia

Objectives

main target Efficacy of olezarsen compared to placebo assessed as change in fasting TG percentage from baseline

Test Drug

Olezarsen (ISIS 678354)

Active Ingredient

Olezarsen

Dosage Form

Solution for injection

Dosage

100 mg / mL

Endpoints

Primary outcome measure was change from baseline in fasting TG percentage at 6 months (average of weeks 25 and 27) compared with placebo

Inclution Criteria

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

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.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    390 participants

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