Olezarsen Clinical Trials (2026): 10 Studies for Familial Chylomicronemia Syndrome & Severe Hypertriglyceridemia
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
10 Olezarsen clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 4 indications (including Familial Chylomicronemia Syndrome & Severe Hypertriglyceridemia) and 3,834 total planned enrollment. 7 Phase 3 Olezarsen trials and 1 Phase 2 are listed. Most recent activity: NCT05130450 (Feb 2028).
Olezarsen clinical trials at a glance: phase × recruitment status
| Phase | active not recruiting | completed | approved for marketing | Total |
|---|---|---|---|---|
| P1 | 1 | 1 | ||
| P2 | 1 | 1 | ||
| P3 | 3 | 4 | 7 | |
| N/A | 1 | 1 |
Olezarsen clinical trials by indication
Familial Chylomicronemia Syndrome (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05130450 | FCS | P3 | active not recruiting | A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS) |
| NCT05185843 | FCS | P3 | active not recruiting | A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen |
| NCT06360237 | FCS | N/A | approved for marketing | Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS) |
| NCT04568434 | BALANCE | P3 | completed | A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS) |
Severe Hypertriglyceridemia (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05681351 | ISIS 678354 | P3 | active not recruiting | CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG) |
| NCT05552326 | — | P3 | completed | A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia |
| NCT05079919 | ISIS 678354 | P3 | completed | A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia |
Hypertriglyceridemia (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05610280 | ISIS 678354 | P3 | completed | A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia |
| NCT05355402 | — | P2 | completed | 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 |
Healthy Participants (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05579860 | AI | P1 | completed | A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants |
Olezarsen pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| FCS | NCT05130450 | P3 | active not recruiting | Familial Chylomicronemia Syndrome | 60 | — |
| FCS | NCT05185843 | P3 | active not recruiting | Familial Chylomicronemia Syndrome | 24 | — |
| ISIS 678354 | NCT05681351 | P3 | active not recruiting | Severe Hypertriglyceridemia | 885 | — |
| ISIS 678354 | NCT05079919 | P3 | completed | Severe Hypertriglyceridemia | 617 | — |
| ISIS 678354 | NCT05610280 | P3 | completed | Hypertriglyceridemia | 1,478 | — |
| BALANCE | NCT04568434 | P3 | completed | Familial Chylomicronemia Syndrome | 66 | — |
All Olezarsen trials (10)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT05130450 | FCS | A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS) | P3 | active not recruiting | 60 | Ionis Pharmaceuticals, Inc. | Nov 2021 |
| NCT05185843 | FCS | A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen | P3 | active not recruiting | 24 | Ionis Pharmaceuticals, Inc. | Feb 2022 |
| NCT05681351 | ISIS 678354 | CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG) | P3 | active not recruiting | 885 | Ionis Pharmaceuticals, Inc. | Dec 2022 |
| NCT05552326 | A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia | P3 | completed | 446 | Ionis Pharmaceuticals, Inc. | Aug 2022 | |
| NCT05079919 | ISIS 678354 | A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia | P3 | completed | 617 | Ionis Pharmaceuticals, Inc. | Oct 2021 |
| NCT05610280 | ISIS 678354 | A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia | P3 | completed | 1,478 | Ionis Pharmaceuticals, Inc. | Nov 2022 |
| NCT06360237 | FCS | Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS) | — | approved for marketing | 0 | Ionis Pharmaceuticals, Inc. | — |
| NCT05355402 | 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 | P2 | completed | 154 | Ionis Pharmaceuticals, Inc. | May 2022 | |
| NCT04568434 | BALANCE | A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS) | P3 | completed | 66 | Ionis Pharmaceuticals, Inc. | Nov 2020 |
| NCT05579860 | AI | A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants | P1 | completed | 104 | Ionis Pharmaceuticals, Inc. | Oct 2022 |
Olezarsen clinical trials: frequently asked questions
- How many Olezarsen clinical trials are there?
- 10 Olezarsen clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 6 are marked completed.
- Are Olezarsen clinical trials recruiting in 2026?
- No active Olezarsen trials are recruiting on ClinicalTrials.gov as of the current AACT refresh. Trials may resume; this page is updated daily.
- What conditions is Olezarsen being studied for?
- Olezarsen is being studied for Familial Chylomicronemia Syndrome, Severe Hypertriglyceridemia, Hypertriglyceridemia, Cardiovascular Diseases, Atherosclerosis and 2 more. The trials are grouped by indication on this page.
- What phase is Olezarsen in?
- Olezarsen clinical trials span 7 Phase 3, 1 Phase 2, 1 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Olezarsen clinical trials?
- The lead sponsor across the most Olezarsen trials is Ionis Pharmaceuticals, Inc.. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Olezarsenas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
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