deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT05610280

A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or With Severe Hypertriglyceridemia

Sponsor: Ionis Pharmaceuticals, Inc.

Updated 22 times since 2022 Last updated: Feb 5, 2026 Started: Nov 21, 2022 Primary completion: Aug 8, 2024 Completion: Jun 9, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Atherosclerosis and Cardiovascular Diseases, this trial is completed. The trial is conducted by Ionis Pharmaceuticals, Inc. and has accumulated 22 data snapshots since 2022. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Status Flow

~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jun 2024 · 6 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~May 2025 · 4 months · monthly snapshot~May 2025 – ~Aug 2025 · 3 months · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshot~Feb 2026 – present · 6 months · monthly snapshot

Change History

22 versions recorded
  1. Feb 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Feb 2026 [monthly]

    Completed PHASE3

  3. Aug 2025 — Sep 2025 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  4. May 2025 — Aug 2025 [monthly]

    Active Not Recruiting PHASE3

  5. Jan 2025 — May 2025 [monthly]

    Active Not Recruiting PHASE3

Show 17 earlier versions
  1. Dec 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE3

  2. Sep 2024 — Dec 2024 [monthly]

    Active Not Recruiting PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  4. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  5. Dec 2023 — Jun 2024 [monthly]

    Recruiting PHASE3

  6. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE3

  7. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE3

  8. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE3

  9. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE3

  10. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE3

  11. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE3

  12. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE3

  13. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE3

  14. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE3

  15. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE3

  16. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE3

  17. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

    First recorded

Nov 2022

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 .