Olezarsen for Hypertriglyceridemia in Patients at High Cardiovascular Risk
Abstract
BACKGROUND: Reducing the levels of triglycerides and triglyceride-rich lipoproteins remains an unmet clinical need. Olezarsen is an antisense oligonucleotide targeting messenger RNA for apolipoprotein C-III (APOC3), a genetically validated target for triglyceride lowering. METHODS: In this phase 2b, randomized, controlled trial, we assigned adults either with moderate hypertriglyceridemia (triglyceride level, 150 to 499 mg per deciliter) and elevated cardiovascular risk or with severe hypertriglyceridemia (triglyceride level, ≥500 mg per deciliter) in a 1:1 ratio to either a 50-mg or 80-mg cohort. Patients were then assigned in a 3:1 ratio to receive monthly subcutaneous olezarsen or matching placebo within each cohort. The primary outcome was the percent change in the triglyceride level from baseline to 6 months, reported as the difference between each olezarsen group and placebo. Key secondary outcomes were changes in levels of APOC3, apolipoprotein B, non-high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol. RESULTS: A total of 154 patients underwent randomization at 24 sites in North America. The median age of the patients was 62 years, and the median triglyceride level was 241.5 mg per deciliter. The 50-mg and 80-mg doses of olezarsen reduced triglyceride levels by 49.3 percentage points and 53.1 percentage points, respectively, as compared with placebo (P<0.001 for both comparisons). As compared with placebo, each dose of olezarsen also significantly reduced the levels of APOC3, apolipoprotein B, and non-HDL cholesterol, with no significant change in the LDL cholesterol level. The risks of adverse events and serious adverse events were similar in the three groups. Clinically meaningful hepatic, renal, or platelet abnormalities were uncommon, with similar risks in the three groups. CONCLUSIONS: In patients with predominantly moderate hypertriglyceridemia at elevated cardiovascular risk, olezarsen significantly reduced levels of triglycerides, apolipoprotein B, and non-HDL cholesterol, with no major safety concerns identified. (Funded by Ionis Pharmaceuticals; Bridge-TIMI 73a ClinicalTrials.gov number, NCT05355402.).
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A phase 2b trial by Bergmark et al. tested the effect of olezarsen on severe hypertriglyceridemia, but the trial was not powered to detect changes in the incidence of pancreatitis.
“A phase 2b trial by Bergmark et al., 37 the results of which are now reported in the Journal , tested the effect of olezarsen on severe hypertriglyceridemia, but the trial was not powered to detect changes in the incidence of pancreatitis.”
From Olezarsen, Acute Pancreatitis, and Familial Chylomicronemia Syndrome (2024) · cites this paper as [37]
Olezarsen shows triglyceride reductions of ~60% and reduced platelet-related adverse events in phase 2/3 and phase 3 data.
“Olezarsen is an antisense oligonucleotide that utilizes triantennary GalNAc-conjugation for liver-specific delivery, allowing for lower doses and improved tolerability, with phase 2/3 and now phase 3 data (including ESSENCE TIMI 73b) showing triglyceride reductions of ~ 60% and reduced platelet-related adverse events [48, 49].”
From Targeting Triglycerides in Cardiovascular Disease Prevention: Evidence, Mechanisms, and Emerging Therapies (2026) · cites this paper as [48]
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InfluentialOlezarsen and Plozasiran in Dyslipidemia Management: A Narrative Review of Clinical Trials
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The ASO drug olezarsen targets familial chylomicronemia syndrome
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- Authors
- Bergmark, B. A., Marston, N. A., Prohaska, T. A., Alexander, V. J., Zimerman, A., Moura, F. A., Murphy, S. A., Goodrich, E. L., Zhang, S., Gaudet, D., Karwatowska-Prokopczuk, E., Tsimikas, S., Giugliano, R. P., & Sabatine, M. S.
- Affiliations
- Brigham and Women's Hospital (US)
- From the TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women’s Hospital, and Harvard Medical School, Boston (B.A.B., N.A.M., A.Z., F.A.M., S.A.M., E.L.G., S.Z., R.P.G., M.S.S.); Ionis Pharmaceuticals, Carlsbad (T.A.P., V.J.A., E.K.-P., S.T.), and the Division of Cardiovascular Medicine, Department of Medicine, University of California, San Diego, La Jolla (S.T.) — both in California; and the Department of Medicine, Université de Montréal and Ecogene-21 Clinical Research Centre, Quebec, QC, Canada (D.G.).
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2024-05-16
- Volume
- 390
- Issue
- 19
- Pages
- 1770-1780
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4394063777
- Semantic Scholar
- e9297203e04305826d00d4054d21576bb119360c
- Cited by
- 198
- References
- 28
- Citations by year
- 2026: 56 · 2025: 97 · 2024: 45
- FWCI
- 55.61
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Ionis Pharmaceuticals
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- olezarsen, hypertriglyceridemia, antisense oligonucleotides, apolipoprotein C-III, triglyceride lowering, cardiovascular risk, apolipoprotein B, non-HDL cholesterol
- MeSH terms
- Heart Disease Risk Factors, Adult, Aged, Hypolipidemic Agents
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