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NCT06360237
Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS)
trial testing Olezarsen in Familial Chylomicronemia Syndrome. Approved for marketing.
Quick facts
| Lead sponsor | Ionis Pharmaceuticals, Inc. |
|---|---|
| Status | APPROVED FOR MARKETING |
| Study type | EXPANDED_ACCESS |
| Sites | 1 location across United States |
Drugs / interventions tested
- Olezarsen — full drug profile →
Conditions studied
- Familial Chylomicronemia Syndrome — all drugs for Familial Chylomicronemia Syndrome →
Sponsor
Ionis Pharmaceuticals, Inc. — full company profile →
Who can join
18 and older, any sex, with Familial Chylomicronemia Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the Expanded Access Program is to provide pre-approval access of olezarsen to eligible patients with Familial Chylomicronemia Syndrome (FCS).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Hepatocyte targeting <i>via</i> the asialoglycoprotein receptor.
Ramírez-Cortés F, Ménová P. · · 2025 · cited 22× · PMID 39628900 · DOI 10.1039/d4md00652f -
Novel Therapeutics for Familial Chylomicronemia Syndrome.
Izar MC, Fonseca FAH. · · 2025 · cited 1× · PMID 40257687 · DOI 10.1007/s11883-025-01295-x
Verify or expand the search:
- PubMed search for NCT06360237
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Olezarsen
Trials testing the same drug.
- NCT05610280 — A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, · Phase 3 · completed
- NCT05579860 — A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healt · Phase 1 · completed
- NCT05552326 — A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia · Phase 3 · completed
- NCT05355402 — A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardi · Phase 2 · completed
- NCT05079919 — A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia · Phase 3 · completed
Other recruiting trials for Familial Chylomicronemia Syndrome
Currently open trials in the same condition.
- NCT06471543 — Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects · Phase 1, PHASE2 · active not recruiting
Other Ionis Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT06673069 — Hero: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) and Pharmacodynamics (PD) of ION269 in Par · Phase 1 · terminated
- NCT06014541 — Observational Study to Characterize Biomarkers and Disease Progression in Participants With Methyl CpG Binding Protein 2 · terminated
- NCT05610280 — A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, · Phase 3 · completed
- NCT05579860 — A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healt · Phase 1 · completed
- NCT05552326 — A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06360237 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ionis Pharmaceuticals, Inc.
- Last refreshed: 27 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06360237.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing