A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)
Part of paid clinical trials in Huntington Beach, California.
- Sponsor
- Ionis Pharmaceuticals, Inc.
- Study ID
- NCT05130450
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
- Familial Chylomicronemia Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Olezarsen — DRUGOlezarsen will be administered by SC injection.
Study Details
The purpose of this study is to evaluate the effect of olezarsen (formerly known as AKCEA-APOCIII-LRx) on the percent change in fasting triglycerides (TG) from baseline.
Key Dates
- Start date
- Nov 18, 2021
- Status verified
- Dec 2025
- Primary completion
- Feb 29, 2028
- Completion
- Feb 29, 2028
Study Design
- Enrollment
- 60 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: OlezarsenOlezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 153.
Primary Outcome Measure
Percent Change From Baseline in Fasting TG at 6 Months (Average of Weeks 23, 25, and 27) Compared to Baseline [ Time Frame: Baseline and 6 months ]
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Diabetes/Lipid Management & Research Center | Huntington Beach | California | 92648 | - |
| Excel Medical Clinical Trials, LLC | Boca Raton | Florida | 33434 | - |
| Department of Pharmacy | Park Ridge | Illinois | 60068 | - |
| University of Kansas Medical Center (KUMC) | Kansas City | Kansas | 66160 | - |
| CTSI Investigational Pharmacy | New York | New York | 10016 | - |
| Milstein Hospital | New York | New York | 10032 | - |
| IDS Central | Philadelphia | Pennsylvania | 19104 | - |
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