Active Not Recruiting PHASE3 INTERVENTIONAL 1-arm NCT05130450

A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)

An Open-Label Extension Study of AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

Sponsor: Ionis Pharmaceuticals, Inc.

Conditions Familial Chylomicronemia Syndrome

Interventions Olezarsen

Updated 24 times since 2021 Last updated: Dec 5, 2025 Started: Nov 18, 2021 Primary completion: Feb 29, 2028 Completion: Feb 29, 2028

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Familial Chylomicronemia Syndrome and is currently ongoing. Ionis Pharmaceuticals, Inc. leads this study, which shows 24 recorded versions since 2021 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

24 versions recorded

Jan 2026 — Present [monthly]

Active Not Recruiting PHASE3
Sep 2025 — Jan 2026 [monthly]

Active Not Recruiting PHASE3
Apr 2025 — Sep 2025 [monthly]

Active Not Recruiting PHASE3
Jan 2025 — Apr 2025 [monthly]

Active Not Recruiting PHASE3
Dec 2024 — Jan 2025 [monthly]

Active Not Recruiting PHASE3

▶ Show 19 earlier versions

Sep 2024 — Dec 2024 [monthly]

Active Not Recruiting PHASE3
Jul 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE3
Jun 2024 — Jul 2024 [monthly]

Active Not Recruiting PHASE3
Jan 2024 — Jun 2024 [monthly]

Active Not Recruiting PHASE3
Dec 2023 — Jan 2024 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Nov 2023 — Dec 2023 [monthly]

Recruiting PHASE3
Oct 2023 — Nov 2023 [monthly]

Recruiting PHASE3
Sep 2023 — Oct 2023 [monthly]

Recruiting PHASE3
Jun 2023 — Sep 2023 [monthly]

Recruiting PHASE3
May 2023 — Jun 2023 [monthly]

Recruiting PHASE3
Mar 2023 — May 2023 [monthly]

Recruiting PHASE3
Jan 2023 — Mar 2023 [monthly]

Recruiting PHASE3
Dec 2022 — Jan 2023 [monthly]

Recruiting PHASE3
Nov 2022 — Dec 2022 [monthly]

Recruiting PHASE3
Sep 2022 — Nov 2022 [monthly]

Recruiting PHASE3
Jul 2022 — Sep 2022 [monthly]

Recruiting PHASE3
Apr 2022 — Jul 2022 [monthly]

Recruiting PHASE3
Feb 2022 — Apr 2022 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Dec 2021 — Feb 2022 [monthly]

Not Yet Recruiting PHASE3

First recorded

Nov 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Ionis Pharmaceuticals, Inc.

Data source: Ionis Pharmaceuticals, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Amsterdam, Netherlands , Barcelona, Spain , Boca Raton, United States , Bratislava, Slovakia , Bron, France , Chicoutimi, Canada , Creixomil, Portugal , Huntington Beach, United States , Kansas City, United States , Le Kremlin-Bicêtre, France and 15 more locations