NCT05079919

A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia

Completed Phase 3 Last updated 10 February 2026

What this trial tests

Phase 3 trial testing Olezarsen in Severe Hypertriglyceridemia in 617 participants. Completed in 8 July 2025.

Timeline

25 October 2021

Primary endpoint
22 October 2024

8 July 2025

Quick facts

Lead sponsor	Ionis Pharmaceuticals, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	617
Start date	25 October 2021
Primary completion	22 October 2024
Estimated completion	8 July 2025
Sites	209 locations across Italy, Finland, Poland, Denmark, New Zealand, Netherlands, Sweden, Bulgaria

Drugs / interventions tested

• Olezarsen — full drug profile →
• Placebo

Conditions studied

• Severe Hypertriglyceridemia — all drugs for Severe Hypertriglyceridemia →

Sponsor

Ionis Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Severe Hypertriglyceridemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nucleic acid drugs: recent progress and future perspectives.
   Sun X, Setrerrahmane S, Li C, Hu J, et al · · 2024 · cited 72× · PMID 39609384 · DOI 10.1038/s41392-024-02035-4
2. Landscape of small nucleic acid therapeutics: moving from the bench to the clinic as next-generation medicines.
   Liu M, Wang Y, Zhang Y, Hu D, et al · · 2025 · cited 62× · PMID 40059188 · DOI 10.1038/s41392-024-02112-8
3. 2023: The year in cardiovascular disease - the year of new and prospective lipid lowering therapies. Can we render dyslipidemia a rare disease by 2024?
   Banach M, Surma S, Toth PP, endorsed by the International Lipid Expert Panel (ILEP). · · 2023 · cited 44× · PMID 38058712 · DOI 10.5114/aoms/174743
4. Updates in Drug Treatment of Severe Hypertriglyceridemia.
   Gouni-Berthold I, Schwarz J, Berthold HK. · · 2023 · cited 38× · PMID 37642858 · DOI 10.1007/s11883-023-01140-z
5. Exploring apolipoprotein C-III: pathophysiological and pharmacological relevance.
   Packard CJ, Pirillo A, Tsimikas S, Ference BA, et al · · 2024 · cited 33× · PMID 38039351 · DOI 10.1093/cvr/cvad177
6. RNA Therapeutics: the Next Generation of Drugs for Cardiovascular Diseases.
   Bejar N, Tat TT, Kiss DL. · · 2022 · cited 32× · PMID 35364795 · DOI 10.1007/s11883-022-01007-9
7. Advances in Dyslipidaemia Treatments: Focusing on ApoC3 and ANGPTL3 Inhibitors.
   Tomlinson B, Wu QY, Zhong YM, Li YH. · · 2024 · cited 29× · PMID 38299167 · DOI 10.12997/jla.2024.13.1.2
8. Hepatocyte targeting <i>via</i> the asialoglycoprotein receptor.
   Ramírez-Cortés F, Ménová P. · · 2025 · cited 22× · PMID 39628900 · DOI 10.1039/d4md00652f