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A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
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
| DRUG: Olezarsen
|
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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