Antisense Inhibition of Apolipoprotein C-III in Patients with Hypertriglyceridemia
Open accessAbstract
BACKGROUND: Apolipoprotein C-III (APOC3) is a key regulator of plasma triglyceride levels. Elevated triglyceride levels are associated with a risk of adverse cardiovascular events and pancreatitis. ISIS 304801 is a second-generation antisense inhibitor of APOC3 synthesis. METHODS: We conducted a randomized, double-blind, placebo-controlled, dose-ranging, phase 2 study to evaluate ISIS 304801 in untreated patients with fasting triglyceride levels between 350 mg per deciliter (4.0 mmol per liter) and 2000 mg per deciliter (22.6 mmol per liter) (ISIS 304801 monotherapy cohort), as well as in patients receiving stable fibrate therapy who had fasting triglyceride levels between 225 mg per deciliter (2.5 mmol per liter) and 2000 mg per deciliter (ISIS 304801-fibrate cohort). Eligible patients were randomly assigned to receive either ISIS 304801, at doses ranging from 100 to 300 mg, or placebo, once weekly for 13 weeks. The primary outcome was the percentage change in APOC3 level from baseline. RESULTS: A total of 57 patients were treated in the ISIS 304801 monotherapy cohort (41 received active agent, and 16 received placebo), and 28 patients were treated in the ISIS 304801-fibrate cohort (20 received active agent, and 8 received placebo). The mean (±SD) baseline triglyceride levels in the two cohorts were 581±291 mg per deciliter (6.6±3.3 mmol per liter) and 376±188 mg per deciliter (4.2±2.1 mmol per liter), respectively. Treatment with ISIS 304801 resulted in dose-dependent and prolonged decreases in plasma APOC3 levels when the drug was administered as a single agent (decreases of 40.0±32.0% in the 100-mg group, 63.8±22.3% in the 200-mg group, and 79.6±9.3% in the 300-mg group, vs. an increase of 4.2±41.7% in the placebo group) and when it was administered as an add-on to fibrates (decreases of 60.2±12.5% in the 200-mg group and 70.9±13.0% in the 300-mg group, vs. a decrease of 2.2±25.2% in the placebo group). Concordant reductions of 31.3 to 70.9% were observed in triglyceride levels. No safety concerns were identified in this short-term study. CONCLUSIONS: We found that treatment with ISIS 304801 was associated with significant lowering of triglyceride levels, among patients with a broad range of baseline levels, through selective antisense inhibition of APOC3 synthesis. (Funded by Isis Pharmaceuticals; ClinicalTrials.gov number, NCT01529424.).
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In a randomized, placebo-controlled, double-blind phase 2 trial of 57 patients with elevated triglycerides, volanesorsen reduced ApoC-III by up to −80% and triglycerides by −71%.
“In a randomized, placebo-controlled, double-blind phase 2 trial of 57 patients with elevated triglycerides, volanesorsen reduced ApoC-III by up to − 80% and triglycerides by − 71% [175].”
From Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention (2023) · cites this paper as [175]
The Methods describe a randomized, double-blind, placebo-controlled phase 2 study, and the Discussion reports mean reductions of 80% in APOC3 and 71% in triglycerides with ISIS 304801 monotherapy. The Results identify 57 patients in the monotherapy cohort, but another 28 in the fibrate cohort; 57 is not the total trial enrollment. (LLM, conf=0.86)
Experimental — accuracy not yet measuredVolanesorsen is an antisense oligonucleotide that targets APOC3 mRNA and reduces plasma apolipoprotein C-III levels, chylomicronemia, and plasma triglyceride levels.
“Volanesorsen is an antisense oligonucleotide that targets APOC3 messenger RNA (mRNA) and reduces plasma apolipoprotein C-III levels, as well as the degree of chylomicronemia and plasma triglyceride levels.”
From Olezarsen, Acute Pancreatitis, and Familial Chylomicronemia Syndrome (2024) · cites this paper as [24]
The RESULTS passage says ISIS 304801 targets APOC3 mRNA, and the Discussion reports reductions in plasma APOC3 and triglycerides. The ISIS 304801 Monotherapy Cohort also reports reduced apoB-48, a marker of chylomicron particle number. Our copy does not identify ISIS 304801 as volanesorsen, so it does not establish that the named drug produced these effects. (LLM, conf=0.82)
Experimental — accuracy not yet measuredVolanesorsen is a second-generation antisense oligonucleotide developed to inhibit apoCIII.
“Volanesorsen (previously known as ISIS-APOC-III RX ) is a second-generation ASO developed to inhibit apoCIII”
From The Forgotten Lipids: Triglycerides, Remnant Cholesterol, and Atherosclerotic Cardiovascular Disease Risk (2019) · cites this paper as [170]
The RESULTS passage describes ISIS 304801 as a second-generation antisense oligonucleotide designed to reduce APOC3 mRNA, supporting the drug class and intended target. Our copy does not identify ISIS 304801 as volanesorsen or ISIS-APOC-III RX, so it does not establish the name equivalence in the citing sentence. (LLM, conf=0.84)
Experimental — accuracy not yet measuredVolanesorsen lowers TG by up to 77% in patients with Familial chylomicronemia syndrome (FCS).
“Volanesorsen, a second-generation antisense oligonucleotide (ASO) targeting hepatic APOC3 mRNA, has shown the capacity to lower TG by up to 77% in patients with Familial chylomicronemia syndrome (FCS) [114]”
From Targeting triglycerides for cardiovascular risk reduction (2026) · cites this paper as [114]
The RESULTS section reports that ISIS 304801 lowered triglycerides in a small number of patients with familial chylomicronemia syndrome, but gives no 77% figure for them. The ISIS 304801 Monotherapy Cohort reports a 70.9% mean reduction at the highest dose in this paper’s hypertriglyceridemia patients, not a 77% reduction in FCS patients. (LLM, conf=0.88)
Experimental — accuracy not yet measuredSeveral miRNAs and antisense oligonucleotides (ASOs) are currently under investigation in clinical trials for various diseases.
“Several miRNAs and antisense oligonucleotides (ASOs) are currently under investigation in clinical trials for various diseases (Kanasty et al., 2013;van Rooij and Kauppinen, 2014;Gaudet et al., 2015).”
From microRNA-33 Regulates ApoE Lipidation and Amyloid-β Metabolism in the Brain (2015) · cites this paper as Gaudet et al., 2015
Several novel therapies that potently reduce triglyceride levels are currently in development.
“Several novel therapies that potently reduce triglyceride levels are currently in development.[6][7][8]”
From Association of Triglyceride-Lowering <i>LPL</i> Variants and LDL-C–Lowering <i>LDLR</i> Variants With Risk of Coronary Heart Disease (2019) · cites this paper as [8]
Volanesorsen has been approved in the European Union and the United Kingdom for treatment of familial chylomicronemia syndrome and in Brazil for familial chylomicronemia syndrome and familial partial lipodystrophy.
“The agent has been approved in the European Union and the United Kingdom for the treatment of familial chylomicronemia syndrome and in Brazil for the treatment of familial chylomicronemia syndrome and familial partial lipodystrophy. 23-25”
From Olezarsen, Acute Pancreatitis, and Familial Chylomicronemia Syndrome (2024) · cites this paper as [24]
The Results section (page unavailable) describes a phase 2 study of ISIS 304801 and mentions earlier treatment of patients with familial chylomicronemia syndrome. Searches for regulatory approval, the European Union, the United Kingdom, Brazil, and familial partial lipodystrophy found no passage addressing the claimed approvals. (LLM, conf=0.76)
Experimental — accuracy not yet measuredIn a Phase 2 trial, volanesorsen 300 mg weekly reduced TG levels by 80% in HTG patients.
“In a Phase 2 trial of volanesorsen, 300 mg given weekly to HTG patients (NCT01529424), TG levels were reduced by 80%.68”
From Clinical review on triglycerides (2020) · cites this paper as [68]
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- Authors
- Gaudet, D., Alexander, V. J., Baker, B. F., Brisson, D., Tremblay, K., Singleton, W., Geary, R. S., Hughes, S. G., Viney, N. J., Graham, M. J., Crooke, R. M., Witztum, J. L., Brunzell, J. D., & Kastelein, J. J. P.
- Affiliations
- University of Washington (US)
- Ionis Pharmaceuticals (United States) (US)
- Université de Montréal (CA)
- University of California San Diego (US)
- Amsterdam UMC Location University of Amsterdam (NL)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-07-30
- Volume
- 373
- Issue
- 5
- Pages
- 438-447
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2315899065
- Semantic Scholar
- b8b4f0ae969760d3373ca1d9082abfee85fe16d9
- Cited by
- 528
- References
- 51
- Citations by year
- 2026: 23 · 2025: 28 · 2024: 27 · 2023: 32 · 2022: 51 · 2021: 46 · 2020: 63 · 2019: 61 · 2018: 68 · 2017: 58 · 2016: 58 · 2015: 13
- FWCI
- 47.75
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (acceptedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- 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
- apolipoprotein C-III, antisense oligonucleotides, hypertriglyceridemia, triglyceride lowering, fibrate therapy, dose-ranging, cardiovascular risk, pancreatitis risk, triglyceride metabolism, monotherapy
- MeSH terms
- Adult, Aged, Aged, 80 and over, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Cholesterol, HDL, Male, Middle Aged, Oligonucleotides, Triglycerides, Hypertriglyceridemia, Apolipoprotein C-III, Fibric Acids
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