Plozasiran, an RNA Interference Agent Targeting APOC3, for Mixed Hyperlipidemia
Abstract
BACKGROUND: Persons with mixed hyperlipidemia are at risk for atherosclerotic cardiovascular disease due to an elevated non-high-density lipoprotein (HDL) cholesterol level, which is driven by remnant cholesterol in triglyceride-rich lipoproteins. The metabolism and clearance of triglyceride-rich lipoproteins are down-regulated through apolipoprotein C3 (APOC3)-mediated inhibition of lipoprotein lipase. METHODS: We carried out a 48-week, phase 2b, double-blind, randomized, placebo-controlled trial evaluating the safety and efficacy of plozasiran, a hepatocyte-targeted APOC3 small interfering RNA, in patients with mixed hyperlipidemia (i.e., a triglyceride level of 150 to 499 mg per deciliter and either a low-density lipoprotein [LDL] cholesterol level of ≥70 mg per deciliter or a non-HDL cholesterol level of ≥100 mg per deciliter). The participants were assigned in a 3:1 ratio to receive plozasiran or placebo within each of four cohorts. In the first three cohorts, the participants received a subcutaneous injection of plozasiran (10 mg, 25 mg, or 50 mg) or placebo on day 1 and at week 12 (quarterly doses). In the fourth cohort, participants received 50 mg of plozasiran or placebo on day 1 and at week 24 (half-yearly dose). The data from the participants who received placebo were pooled. The primary end point was the percent change in fasting triglyceride level at week 24. RESULTS: A total of 353 participants underwent randomization. At week 24, significant reductions in the fasting triglyceride level were observed with plozasiran, with differences, as compared with placebo, in the least-squares mean percent change from baseline of -49.8 percentage points (95% confidence interval [CI], -59.0 to -40.6) with the 10-mg-quarterly dose, -56.0 percentage points (95% CI, -65.1 to -46.8) with the 25-mg-quarterly dose, -62.4 percentage points (95% CI, -71.5 to -53.2) with the 50-mg-quarterly dose, and -44.2 percentage points (95% CI, -53.4 to -35.0) with the 50-mg-half-yearly dose (P<0.001 for all comparisons). Worsening glycemic control was observed in 10% of the participants receiving placebo, 12% of those receiving the 10-mg-quarterly dose, 7% of those receiving the 25-mg-quarterly dose, 20% of those receiving the 50-mg-quarterly dose, and 21% of those receiving the 50-mg-half-yearly dose. CONCLUSIONS: In this randomized, controlled trial involving participants with mixed hyperlipidemia, plozasiran, as compared with placebo, significantly reduced triglyceride levels at 24 weeks. A clinical outcomes trial is warranted. (Funded by Arrowhead Pharmaceuticals; MUIR ClinicalTrials.gov number NCT04998201.).
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Mild elevations in aminotransferase levels as well as small increases in glycated hemoglobin levels have also been seen with plozasiran and are similar to the now well-established safety profile of statins.
“Mild elevations in aminotransferase levels as well as small increases in glycated hemoglobin levels have also been seen with plozasiran 18,23,29 and are similar to the now well-established safety profile of statins. 30,31”
From Targeting <i>APOC3</i> with Olezarsen in Moderate Hypertriglyceridemia (2025) · cites this paper as [23]
In MUIR and SHASTA-2, plozasiran reduced TG by 50-60% and improved remnant cholesterol, non-HDL-C, and apoB, while modest, dose-dependent LDL-C increases were observed at higher doses.
“In MUIR [119] and SHASTA-2 [120], plozasiran similarly reduced TG by 50–60% and improved remnant cholesterol, non–HDL-C, and apoB, while modest, dose-dependent LDL-C increases were observed at higher doses.”
From Targeting triglycerides for cardiovascular risk reduction (2026) · cites this paper as [119]
Four randomized controlled trials met eligibility criteria and were included in the meta-analysis.
“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 [16]
The meta-analysis included 1,514 participants, with 534 assigned to plozasiran and 980 receiving placebo.
“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 [16]
HDL-C analysis at 24 weeks showed significant heterogeneity (P = 0.02, I2 = 60%), which was resolved by excluding the study by Ballantyne et al. (2024) (50 mg H) (P = 0.15, I2 = 38%).
“At 24 weeks, the analysis showed significant heterogeneity (P = 0.02, I² = 60%), which was resolved by excluding the study by Ballantyne et al. (2024) [16] (50 mg, H) (P = 0.15, I² = 38%).”
From The Efficacy and Safety of Plozasiran on Lipid Profile in Dyslipidemic Disorders: A Systematic Review and Meta-Analysis (2026) · cites this paper as [16]
Excluding Ballantyne et al., 2024 [16] (50 mg, H) resolved the heterogeneity at 24 weeks for Non-HDL cholesterol (P = 0.35, I2 = 10%).
“which was resolved after excluding Ballantyne et al., 2024 [16] (50 mg, H) (P = 0.35, I² = 10%)”
From The Efficacy and Safety of Plozasiran on Lipid Profile in Dyslipidemic Disorders: A Systematic Review and Meta-Analysis (2026) · cites this paper as [16]
Excluding Ballantyne et al., 2024 [16] (50 mg, Q) resolved the heterogeneity at the end of the study for AST (P = 0.35, I2 = 10%).
“which was resolved by excluding Ballantyne et al., 2024 [16] (50 mg, Q) (P = 0.35, I² = 10%)”
From The Efficacy and Safety of Plozasiran on Lipid Profile in Dyslipidemic Disorders: A Systematic Review and Meta-Analysis (2026) · cites this paper as [16]
Plozasiran is associated with a higher incidence of headaches.
“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 [16]
Trials mitigated the rises in liver transaminases by changing dosing and frequency.
“Moreover, the rises seen in liver transaminases were considered non-serious and associated with higher and more frequent doses of plozasiran, which trials mitigated by changing dosing and frequency [16, 22].”
From The Efficacy and Safety of Plozasiran on Lipid Profile in Dyslipidemic Disorders: A Systematic Review and Meta-Analysis (2026) · cites this paper as [16]
Rises in liver transaminases were considered non-serious.
“Moreover, the rises seen in liver transaminases were considered non-serious and associated with higher and more frequent doses of plozasiran, which trials mitigated by changing dosing and frequency [16, 22].”
From The Efficacy and Safety of Plozasiran on Lipid Profile in Dyslipidemic Disorders: A Systematic Review and Meta-Analysis (2026) · cites this paper as [16]
Ballantyne et al. (2024) included patients with mixed dyslipidemia to explore whether plozasiran's lipid-lowering effects could extend to individuals at risk for ASCVD and support the rationale for a dedicated cardiovascular outcomes trial.
“Ballantyne et al. (2024) included patients with mixed dyslipidemia to explore whether plozasiran’s lipid-lowering effects could extend to individuals at risk for ASCVD and support the rationale for a dedicated cardiovascular outcomes trial [16].”
From The Efficacy and Safety of Plozasiran on Lipid Profile in Dyslipidemic Disorders: A Systematic Review and Meta-Analysis (2026) · cites this paper as [16]
Changes in ALT and AST levels were dose- and regimen-dependent and associated with higher and more frequent doses of plozasiran.
“Subgroup analyses confirmed that changes in HbA1c, ALT, and AST levels were dose- and regimen-dependent.”
From The Efficacy and Safety of Plozasiran on Lipid Profile in Dyslipidemic Disorders: A Systematic Review and Meta-Analysis (2026) · cites this paper as [16]
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siRNA-based delivery systems: Technologies, carriers, applications, and approved products
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Residual lipid risk in atherosclerotic cardiovascular disease
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Self-citationMolecular Regulation and Therapeutic Targeting of VLDL Production in Cardiometabolic Disease
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Familial chylomicronemia syndrome and treatments to target hepatic APOC3 mRNA
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Impact of Remnant Cholesterol on Cardiovascular Risk in Diabetes
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Elevated Remnant and LDL Cholesterol and the Risk of Peripheral Artery Disease
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Self-citationAnti-apoC-III Therapies and Implications for Treatment of Pancreatitis and Cardiovascular Disease
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Novel RNA-Based Therapies in the Management of Dyslipidemias
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Joint Associations of APOC3 and LDL-C–Lowering Variants With the Risk of Coronary Heart Disease
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Olezarsen, a liver-directed APOC3 ASO therapy for hypertriglyceridemia
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Atherogenic dyslipidaemia and residual cardiovascular risk: Understanding the link to heart disease
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Recent Advances in the Management of Dyslipidemia: A Systematic Review
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Self-citationApproach to Lipid Management in the Patient With Diabetes
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Self-citationInteraction Between Primary Hyperlipidemias and Type 2 Diabetes: Therapeutic Implications
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Research advances in current drugs targeting hyperlipidemia (Review)
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Advancements in research to mitigate residual risk of atherosclerotic cardiovascular disease
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Triglycerides: the past, the present, and the future
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ApoC-III as Therapeutic Target: Is it Primetime for Clinical Use?
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Genetics of remnant cholesterol
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Discovery of long-acting APOC3 siRNA for treating patients with hypertriglyceridemia
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RNA interference therapy in cardiology: will new targets improve therapeutic goals?
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New Approaches to Lipoproteins for the Prevention of Cardiovascular Events
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Pharmacotherapy of cardiovascular diseases from herbs and pills to nucleic acids
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RNA-based drugs: current, imminent and possible therapeutic applications
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Schwartz, G. G., Szarek, M. J., Reijnders, E., Jukema, J. W., Bhatt, D. L., Bittner, V., Fazio, S., Garon, G., Goodman, S. G., Harrington, R. A., et al. (2025) · European Journal of Preventive Cardiology · doi:10.1093/eurjpc/zwaf067 · Cited by 7 · see citing works
Emerging agents targeting triglycerides
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An up-to-date review of emerging biologic therapies for hypercholesterolemia
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Comprehensive evaluation of siRNA therapeutics on Lp(a): A network meta‐analysis
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PPARɑ variant V227A reduces plasma triglycerides through enhanced lipoprotein lipolysis
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Self-citationRemnant cholesterol, inflammation and atherosclerosis
Brunham, L. R. (2025) · European Journal of Preventive Cardiology · doi:10.1093/eurjpc/zwaf098 · Cited by 6 · see citing works
Sydhom, P., Al-Quraishi, B., Gohar, A., El-Shawaf, M., Shehata, N., Ataya, M., Sydhom, M., Awwad, N., Motawade, H., Naji, N., et al. (2026) · Cardiovascular Drugs and Therapy · doi:10.1007/s10557-025-07798-8 · Cited by 5 · see citing works
“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 plo-zasiran, and 980 receiving placebo.”
InfluentialHenry, D., Baugé, E., Staels, B., & Lalloyer, F. (2025) · Pharmacological Reviews · doi:10.1016/j.pharmr.2025.100086 · Cited by 5 · see citing works
Safety, pharmacokinetics and pharmacodynamics of Plozasiran in Chinese healthy volunteers
Wang, F., You, D., Niu, X., Shi, J. G., Li, Y., Qi, L., & Li, H. (2025) · Cardiovascular Diabetology · doi:10.1186/s12933-025-02929-9 · Cited by 5 · see citing works
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New and Emerging Therapeutic Targets for ApoB-Containing Particles Lowering
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Advances in Clinical Cardiology 2024: A Summary of Key Clinical Trials
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“In a meta-analysis comprising six RCTs (Gaudet et al., 2024; Ray et al., 2025; Tardif et al., 2022; Ballantyne et al., 2024; Rosenson et al., 2024; Bergmark et al., 2025), 2,451 participants (mean [SD] age, 61.4 [10.4] years; 1,470 male [60”
Influential
- Authors
- Ballantyne, C. M., Vasas, S., Azizad, M., Clifton, P., Rosenson, R. S., Chang, T., Melquist, S., Zhou, R., Mushin, M., Leeper, N. J., Hellawell, J., & Gaudet, D.
- Affiliations
- Royal Adelaide Hospital (AU)
- From the Baylor College of Medicine and the Texas Heart Institute, Houston (C.M.B.); Borbánya Praxis, Nyíregyháza, Hungary (S.V.); Valley Clinical Trials, Northridge (M.A.), Arrowhead Pharmaceuticals, Pasadena (T.C., S.M., R.Z., M.M., J.H.), and the Stanford School of Medicine, Stanford (N.J.L.) — all in California; the Royal Adelaide Hospital, Adelaide, SA, Australia (P.C.); the Icahn School of Medicine at Mount Sinai, New York (R.S.R.); and the Department of Medicine, Université de Montréal and Ecogene-21, Quebec, QC, Canada (D.G.).
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2024-09-12
- Volume
- 391
- Issue
- 10
- Pages
- 899-912
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4399087766
- Semantic Scholar
- c67a77a19492dfb8d4608c1ccc2c06e5e7c68abe
- Cited by
- 210
- References
- 44
- Citations by year
- 2026: 73 · 2025: 106 · 2024: 30
- FWCI
- 55.75
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Arrowhead Pharmaceuticals
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › RNA Interference and Gene Delivery
- Keywords
- plozasiran, apolipoprotein C-III, siRNA, mixed dyslipidemia, triglyceride-rich lipoproteins, remnant cholesterol, non-HDL cholesterol, lipoprotein lipase inhibition, triglyceride lowering, atherosclerotic cardiovascular disease, dose comparison, safety and tolerability, subcutaneous injection
- MeSH terms
- RNAi Therapeutics, Adult, Aged, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Hyperlipidemias, Cholesterol, LDL, Male, Middle Aged, Triglycerides, RNA, Small Interfering, Apolipoprotein C-III
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