Reduction in lipoprotein-associated apoC-III levels following volanesorsen therapy: phase 2 randomized trial results
Open accessAbstract
Elevated apoC-III levels predict increased cardiovascular risk when present on LDL and HDL particles. We developed novel high-throughput chemiluminescent ELISAs that capture apoB, lipoprotein (a) [Lp(a)], and apoA-I in plasma and then detect apoC-III on these individual lipoproteins as apoCIII-apoB, apoCIII-Lp(a), and apoCIII-apoAI complexes, respectively. We assessed the effects on these complexes of placebo or 100-300 mg volanesorsen, a generation 2.0+ antisense drug that targets apoC3 mRNA in patients with hypertriglyceridemia, including familial chylomicronemia syndrome (n = 3), volanesorsen monotherapy (n = 51), and as add-on to fibrate (n = 26), treated for 85 days and followed for 176 days. Compared with placebo, volanesorsen was associated with an 82.3 ± 11.7%, 81.3 ± 15.7%, and 80.8 ± 13.6% reduction in apoCIII-apoB, apoCIII-Lp(a), and apoCIII-apoA-I, respectively (300 mg dose;P< 0.001 for all), at day 92. Strong correlations in all assay measures were noted with total plasma apoC-III, chylomicron-apoC-III, and VLDL-apoC-III. In conclusion, novel high-throughput ELISAs were developed to detect lipoprotein-associated apoC-III, including for the first time on Lp(a). Volanesorsen uniformly lowers apoC-III on apoB-100, Lp(a), and apoA-I lipoproteins, and may be a potent agent to reduce triglycerides and cardiovascular risk mediated by apoC-III.
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In the COMPASS trial, volanesorsen demonstrated substantial triglyceride reductions (~71%) and improved metabolic parameters in patients with multifactorial chylomicronemia.
“The COMPASS trial, which evaluated volanesorsen in patients with multifactorial chylomicronemia (with partial LPL activity), similarly demonstrated substantial TG reductions (~ 71%) and improved metabolic parameters, broadening the potential utility of apoC-III inhibition beyond the rare FCS population.”
From Targeting Triglycerides in Cardiovascular Disease Prevention: Evidence, Mechanisms, and Emerging Therapies (2026) · cites this paper as [46]
The introduction (p. 2) reports approximately 70% triglyceride reductions with volanesorsen across earlier studies, and the Discussion (p. 7) identifies COMPASS as a volanesorsen study in patients with hypertriglyceridemia. It describes COMPASS as ongoing, however; it does not report a 71% reduction or improved metabolic parameters from that trial, or identify its participants as having multifactorial chylomicronemia with partial LPL activity. (LLM, conf=0.86)
Experimental — accuracy not yet measuredVolanesorsen reduces apoC-III by ~80-88% and increases HDL-C by ~42% compared with placebo.
“In addition to TG lowering, volanesorsen has been shown to reduce apoC-III by ~ 80–88% and increase HDL-C by ~ 42% compared with placebo [45–47].”
From Targeting Triglycerides in Cardiovascular Disease Prevention: Evidence, Mechanisms, and Emerging Therapies (2026) · cites this paper as [46]
The Abstract (p. 2) reports approximately 81–82% reductions in lipoprotein-associated apoC-III versus placebo at the 300 mg dose, supporting the apoC-III portion approximately. The Laboratory measurements section (p. 3) says HDL-C was measured, but the passages found do not report a 42% HDL-C increase versus placebo. (LLM, conf=0.88)
Experimental — accuracy not yet measuredVolanesorsen treatment correlated with >80% reductions in apo C-III, favourable changes across multiple lipoprotein species, unchanged LDL-C and improved carbohydrate metabolism.
“This correlated with >80% reductions in apo C-III, favourable changes across multiple lipoprotein species, unchanged LDL-C and improved carbohydrate metabolism.69–71”
From Clinical review on triglycerides (2020) · cites this paper as [69]
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- Authors
- Yang, X., Lee, S.-R., Choi, Y.-S., Alexander, V. J., Digenio, A., Yang, Q., Miller, Y. I., Witztum, J. L., & Tsimikas, S.
- Affiliations
- University of California San Diego (US)
- Ionis Pharmaceuticals (United States) (US)
- Corresponding author
- Tsimikas, Sotirios
- ORCID
- Venue
- Journal of Lipid Research
- Publisher
- Elsevier BV
- Published
- 2016-04
- Volume
- 57
- Issue
- 4
- Pages
- 706-713
- ISSN
- 0022-2275 (ISSN-L)
- PMC
- PMC4808774
- OpenAlex
- W2318839442
- Cited by
- 103
- References
- 36
- Citations by year
- 2026: 3 · 2025: 7 · 2024: 6 · 2023: 8 · 2022: 6 · 2021: 6 · 2020: 10 · 2019: 16 · 2018: 14 · 2017: 19 · 2016: 8
- FWCI
- 15.65
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Lipid Research (publishedVersion, cc-by)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- National Institutes of Health (HL119828)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Keywords
- volanesorsen, apolipoprotein C-III, lipoprotein(a), apolipoprotein B, apolipoprotein A-I, hypertriglyceridemia, familial chylomicronemia syndrome, antisense therapy, triglyceride lowering, cardiovascular risk, chemiluminescent ELISA, VLDL, chylomicrons
- MeSH terms
- Cardiovascular Diseases, Female, Humans, Male, Middle Aged, RNA, Messenger, Triglycerides, Oligonucleotides, Antisense, Apolipoprotein C-III
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