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Plozasiran for Managing Persistent Chylomicronemia and Pancreatitis Risk
Abstract
Background Persistent chylomicronemia is a genetic recessive disorder that is classically caused by familial chylomicronemia syndrome (FCS), but it also has multifactorial causes. The disorder is associated with the risk of recurrent acute pancreatitis. Plozasiran is a small interfering RNA that reduces hepatic production of apolipoprotein C-III and circulating triglycerides. Methods In a phase 3 trial, we randomly assigned 75 patients with persistent chylomicronemia (with or without a genetic diagnosis) to receive subcutaneous plozasiran (25 mg or 50 mg) or placebo every 3 months for 12 months. The primary end point was the median percent change from baseline in the fasting triglyceride level at 10 months. Key secondary end points were the percent change in the fasting triglyceride level from baseline to the mean of values at 10 months and 12 months, changes in the fasting apolipoprotein C-III level from baseline to 10 months and 12 months, and the incidence of acute pancreatitis. Results At baseline, the median triglyceride level was 2044 mg per deciliter. At 10 months, the median change from baseline in the fasting triglyceride level (the primary end point) was -80% in the 25-mg plozasiran group, -78% in the 50-mg plozasiran group, and -17% in the placebo group (P Conclusions Patients with persistent chylomicronemia who received plozasiran had significantly lower triglyceride levels and a lower incidence of pancreatitis than those who received placebo. (Funded by Arrowhead…
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In the citing paper
“In the phase 3 PALISADE trial [118], plozasiran reduced apoC-III by ~ 90% and TG by 78–80% at 10 months, achieving TG levels < 500 mg/dL in about half of patients and < 150 mg/dL in over 90% of those with partial LPL activity.”
From Targeting triglycerides for cardiovascular risk reduction (2026) · cites this paper as [118]
In the citing paper
“Ultimately, four RCTs met al.l eligibility criteria and were included in the final analysis [16, 17, 22, 23].”
From The Efficacy and Safety of Plozasiran on Lipid Profile in Dyslipidemic Disorders: A Systematic Review and Meta-Analysis (2026) · cites this paper as [17]
In the citing paper
“The meta-analysis included data from 4 clinical trials [16, 17, 22, 23], encompassing a total of 1,514 participants—534 assigned to various doses and treatment durations of plozasiran, and 980 receiving placebo.”
From The Efficacy and Safety of Plozasiran on Lipid Profile in Dyslipidemic Disorders: A Systematic Review and Meta-Analysis (2026) · cites this paper as [17]
In the citing paper
“In contrast, recent trials by Watts et al. (2025) [17] and Gaudet et al. (2024) [23] demonstrated that plozasiran was able to achieve guideline-recommended triglyceride targets (< 500 mg/dL) and reduce the incidence of acute pancreatitis events [Watts 2025; Gaudet 2024].”
From The Efficacy and Safety of Plozasiran on Lipid Profile in Dyslipidemic Disorders: A Systematic Review and Meta-Analysis (2026) · cites this paper as [17]
In the citing paper
“Concerning safety findings for plozasiran, we observed slight increases in HbA1c, AST, and ALT levels, along with a higher incidence of headaches.”
From The Efficacy and Safety of Plozasiran on Lipid Profile in Dyslipidemic Disorders: A Systematic Review and Meta-Analysis (2026) · cites this paper as [17]
In the citing paper
“Watts et al. (2025) focused on individuals with genetically confirmed familial chylomicronemia syndrome (FCS) or symptomatic persistent chylomicronemia, aiming to assess reductions in acute pancreatitis events [17].”
From The Efficacy and Safety of Plozasiran on Lipid Profile in Dyslipidemic Disorders: A Systematic Review and Meta-Analysis (2026) · cites this paper as [17]
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Metadata
- Authors
- Watts, G. F., Rosenson, R. S., Hegele, R. A., Goldberg, I. J., Gallo, A., Mertens, A., Baass, A., Zhou, R., Muhsin, M., Hellawell, J., Leeper, N. J., & Gaudet, D.
- Affiliations
- Inserm (FR)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2025-01-09
- Volume
- 392
- Issue
- 2
- Pages
- 127-137
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4402146754
- Semantic Scholar
- 7e77ad0e7b828bad027c2dd2d373cdb99622ce79
- Cited by
- 178
- References
- 42
- Citations by year
- 2026: 82 · 2025: 81
- FWCI
- 47.48
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- UWA Profiles and Research Repository (UWA) (submittedVersion)
- Lirias (KU Leuven) (submittedVersion)
- Funders
- Arrowhead Pharmaceuticals
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Lymphatic Disorders and Treatments
- Keywords
- plozasiran, familial chylomicronemia syndrome, acute pancreatitis, apolipoprotein C-III, triglycerides, siRNA, hypertriglyceridemia, hyperglycemia, adverse events, prediabetes, diabetes mellitus, familial hypertriglyceridemia, familial combined hyperlipidemia
- MeSH terms
- Acute Disease, Adult, Aged, Double-Blind Method, Female, Humans, Injections, Subcutaneous, Hyperlipoproteinemia Type I, Male, Middle Aged, Pancreatitis, Triglycerides, Incidence, RNA, Small Interfering, Apolipoprotein C-III, Young Adult
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