A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen
Part of paid clinical trials in Huntington Beach, California.
- Sponsor
- Ionis Pharmaceuticals, Inc.
- Study ID
- NCT05185843
- 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 the study is to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) effects of olezarsen (formerly known as AKCEA -APOCIII-LRX) in participants with FCS previously treated with volanesorsen.
Key Dates
- Start date
- Feb 25, 2022
- Status verified
- Dec 2025
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 24 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 for up to 209 weeks.
Primary Outcome Measure
Proportion of Participants With Decrease in Platelet Count by >30% or >50%, or With Platelet Count Value <50,000/cubic millimeter (mm^3) [ Time Frame: Baseline to Week 209 ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Diabetes/Lipid Management & Research Center | Huntington Beach | California | 92648 | - |
| Excel Medical Clinical Trials, LLC | Boca Raton | Florida | 33434 | - |
| University of Michigan, Department of Internal Medicine, Division of Metabolism, Endocrinology and Diabetes (MEND) | Ann Arbor | Michigan | 48109-2800 | - |
| University of Rochester School of Medicine | Rochester | New York | 14642 | - |
Find similar trials in Huntington Beach, CA
By research site
Diabetes/Lipid Management & Research Center· Huntington Beach, CAExcel Medical Clinical Trials, LLC· Boca Raton, FLUniversity of Michigan, Department of Internal Medicine, Division of Metabolism, Endocrinology and Diabetes (MEND)· Ann Arbor, MIUniversity of Rochester School of Medicine· Rochester, NY