6 completed, 3 active not recruiting, 1 approved for marketing, 1 recruiting. 8 Phase 3, 1 Phase 1, 1 Phase 2.
By phase and status
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
A Study of Olezarsen for the Treatment of Familial Chylomicronemia Syndrome (FCS) in Pediatric Participants Olezarsen - Familial Chylomicronemia Syndrome | Phase 3 | Recruiting | 12 | 2026-07-31 | 2026-10-08 |
CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG) Olezarsen - Severe Hypertriglyceridemia | Phase 3 | Active not recruiting | 885 | 2022-12-13 | 2025-12-01 |
A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia Olezarsen, Placebo - Hypertriglyceridemia, Cardiovascular Diseases | Phase 3 | Completed | 1478 | 2022-11-21 | 2026-02-10 |
A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants Olezarsen - Healthy Participants | Phase 1 | Completed | 104 | 2022-10-05 | 2024-05-10 |
A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia Olezarsen, Placebo - Severe Hypertriglyceridemia | Phase 3 | Completed | 446 | 2022-08-31 | 2025-10-22 |
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia Olezarsen, Placebo - Hypertriglyceridemia, Atherosclerotic Cardiovascular Disease | Phase 2 | Completed | 154 | 2022-05-09 | 2026-04-23 |
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen Olezarsen - Familial Chylomicronemia Syndrome | Phase 3 | Active not recruiting | 24 | 2022-02-25 | 2025-12-12 |
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS) Olezarsen - Familial Chylomicronemia Syndrome | Phase 3 | Active not recruiting | 60 | 2021-11-18 | 2025-12-12 |
A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia Olezarsen, Placebo - Severe Hypertriglyceridemia | Phase 3 | Completed | 617 | 2021-10-25 | 2026-02-10 |
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS) Olezarsen, Placebo - Familial Chylomicronemia Syndrome | Phase 3 | Completed | 66 | 2020-11-18 | 2025-03-06 |
Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS) Olezarsen - Familial Chylomicronemia Syndrome | | Approved for marketing | | | 2024-12-27 |
Conditions studied
Familial hyperchylomicronemia syndrome (5) · Hypertriglyceridemia (5) · Atherosclerosis (2) · Hyperlipidemias (2) · Metabolic Diseases (2) · Cardiovascular Diseases (1) · Dyslipidemias (1) · Genetic Diseases, Inborn (1) · Hyperlipoproteinemia Type I (1) · Hyperlipoproteinemias (1) · Lipid Metabolism Disorders (1) · Lipid Metabolism, Inborn Errors (1) · Metabolism, Inborn Errors (1)
Sponsors
Ionis Pharmaceuticals, Inc. (11)
Countries
United States (11) · Canada (8) · France (6) · Italy (6) · Netherlands (6) · Portugal (6) · Slovakia (6) · Spain (6) · Sweden (6) · Norway (5) · Bulgaria (4) · Czechia (4) · Hungary (4) · Poland (4) · United Kingdom (4)
Results publications
PMID 40064331, PMID 41211918, PMID 38587247, PMID 38587249, PMID 40081744, PMID 40888739, PMID 41545246, PMID 41910513
NIH funding
2023 (1)