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Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol
Open accessAbstract
BACKGROUND: Inclisiran inhibits hepatic synthesis of proprotein convertase subtilisin-kexin type 9. Previous studies suggest that inclisiran might provide sustained reductions in low-density lipoprotein (LDL) cholesterol levels with infrequent dosing. METHODS: We enrolled patients with atherosclerotic cardiovascular disease (ORION-10 trial) and patients with atherosclerotic cardiovascular disease or an atherosclerotic cardiovascular disease risk equivalent (ORION-11 trial) who had elevated LDL cholesterol levels despite receiving statin therapy at the maximum tolerated dose. Patients were randomly assigned in a 1:1 ratio to receive either inclisiran (284 mg) or placebo, administered by subcutaneous injection on day 1, day 90, and every 6 months thereafter over a period of 540 days. The coprimary end points in each trial were the placebo-corrected percentage change in LDL cholesterol level from baseline to day 510 and the time-adjusted percentage change in LDL cholesterol level from baseline after day 90 and up to day 540. RESULTS: A total of 1561 and 1617 patients underwent randomization in the ORION-10 and ORION-11 trials, respectively. Mean (±SD) LDL cholesterol levels at baseline were 104.7±38.3 mg per deciliter (2.71±0.99 mmol per liter) and 105.5±39.1 mg per deciliter (2.73±1.01 mmol per liter), respectively. At day 510, inclisiran reduced LDL cholesterol levels by 52.3% (95% confidence interval [CI], 48.8 to 55.7) in the ORION-10 trial and by 49.9% (95% CI, 46.6 to 53.1) in the ORION-11 trial, with corresponding time-adjusted reductions of 53.8% (95% CI, 51.3 to 56.2) and 49.2% (95% CI, 46.8 to 51.6) (P<0.001 for all comparisons vs. placebo). Adverse events were generally similar in the inclisiran and placebo groups in each trial, although injection-site adverse events were more frequent with inclisiran than with placebo (2.6% vs. 0.9% in the ORION-10 trial and 4.7% vs. 0.5% in the ORION-11 trial); such reactions were generally mild, and none were severe or persistent. CONCLUSIONS: Reductions in LDL cholesterol levels of approximately 50% were obtained with inclisiran, administered subcutaneously every 6 months. More injection-site adverse events occurred with inclisiran than with placebo. (Funded by the Medicines Company; ORION-10 and ORION-11 ClinicalTrials.gov numbers, NCT03399370 and NCT03400800.).
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“Randomized controlled trials, including the VICTORION-Mono and VICTORION-Difference trials, as well as ORION -10, -11, and other Phase III trials, have consistently demonstrated that inclisiran reduces LDL-C compared with placebo in primary and secondary prevention settings.5, 6, 7”
From Small Interfering RNA for LDL-Cholesterol Reduction (2026) · cites this paper as [7]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“The trials showed that patients achieved LDL-C decreases of 52.3% and 49.9% at Day 510 [44].”
From Inclisiran SiRNA therapy for durable LDL-C reduction: a systematic review and meta-analysis highlighting a breakthrough in long-term cardiovascular risk management (2026) · cites this paper as [44]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“The ORION-10 and ORION-11 trials achieved LDL-C reductions greater than 50% among their participants [44].”
From Inclisiran SiRNA therapy for durable LDL-C reduction: a systematic review and meta-analysis highlighting a breakthrough in long-term cardiovascular risk management (2026) · cites this paper as [44]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“The initial injections of inclisiran at Day 1 and 90 followed by biannual maintenance resulted in a long-term average LDL-C reduction of − 44% to − 48% across ORION-1 and ORION-10 and ORION-11 [25, 44].”
From Inclisiran SiRNA therapy for durable LDL-C reduction: a systematic review and meta-analysis highlighting a breakthrough in long-term cardiovascular risk management (2026) · cites this paper as [44]
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“Clinical observations demonstrate that numerous patients stop taking their daily statin medications or PCSK9 antibody injections irregularly which reduces their ability to prevent cardiovascular diseases [44, 80].”
From Inclisiran SiRNA therapy for durable LDL-C reduction: a systematic review and meta-analysis highlighting a breakthrough in long-term cardiovascular risk management (2026) · cites this paper as [44]
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“Accordingly, PCSK9 siRNA and monoclonal antibodies blocking the PCSK9/LDLR interaction potently lower LDL cholesterol and reduce the risk of adverse cardiovascular events (Sabatine et al., 2017; Schwartz et al., 2018; Ray et al., 2020).”
From PCSK9 deficiency alters brain lipid composition without affecting brain development and function (2023) · cites this paper as Ray et al., 2020
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
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“Accordingly, PCSK9 inhibitory antibodies and siRNA potently reduce LDL cholesterol to unprecedented low levels and are approved for treatment of hypercholesterolemia.”
From PCSK9 deficiency alters brain lipid composition without affecting brain development and function (2023) · cites this paper as Ray et al., 2020
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“targeted PCSK9 inhibition restores hepatic LDLR levels, decreases plasma LDL-C levels and improves cardiovascular outcomes.7,9–11”
From Sirtuin-1 directly binds and deacetylates hepatic PCSK9 thereby promoting the inhibition of LDL receptor degradation (2025) · cites this paper as [11]
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In the citing paper
“The phase 3 ORION-10 and ORION-11 trials evaluated inclisiran compared with placebo across a total of 1561 and 1617 patients with atherosclerosis or an atherosclerotic CVD risk-equivalent, respectively [137]. Compared with placebo, inclisiran reduced LDL-C levels by − 52% and − 50%, respectively.”
From Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention (2023) · cites this paper as [137]
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“In addition to monoclonal antibodies that sequester PCSK9 in the circulation and are now prescribed to patients, the small-interfering RNA inclisiran that targets PCSK9 hepatic production has recently been approved, following reports of substantial LDL lowering [50% reduction (95% confidence interval 47–53)] with this drug (11).”
From PCSK9 and the nervous system: a no-brainer? (2023) · cites this paper as [11]
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“In addition to the monoclonal antibodies, an siRNA, inclisiran, which also targets PSCK9, has demonstrated the ability to reduce LDL cholesterol by 49-52% in trials evaluating individuals with established cardiovascular disease or ASCVD risk equivalent (129).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [129]
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In the citing paper
“In addition to the monoclonal antibodies, an siRNA, inclisiran, which also targets PSCK9 and is referred to as a PCSK9 siRNA in this section, has demonstrated the ability to reduce LDL cholesterol by 49–52% in trials evaluating individuals with established CVD or ASCVD risk equivalent (123).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [123]
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In the citing paper
“Inclisiran was noted to decrease LDL by ∼50% in the ORION trials [20]”
From Oral PCSK9 inhibitors for elevated LDL-C: A systematic review and meta-analysis of randomized trials (2026) · cites this paper as [20]
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In the citing paper
“The analysis of 11 RCTs for quantitative synthesis included more than 13,000 participants showed inclisiran produces significant LDL-C reduction versus placebo treatment [24, 25, 38–44, 46, 49].”
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In the citing paper
“Large-scale research including well-powered trials such as ORION 10 and ORION 11 demonstrates that Inclisiran shows strong potential as a potent lipid-lowering agent [44].”
In the citing paper
“Patients on statins with high LDL-C levels and ASCVD or at least one ASCVD risk equivalent were included in the two phase 3 trials ORION-10 and ORION-11 (Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol), and obtained a further 50% reduction of LDL-C with inclisiran.278”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [278]
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Metadata
- Authors
- Ray, K. K., Wright, R. S., Kallend, D., Koenig, W., Leiter, L. A., Raal, F. J., Bisch, J. A., Richardson, T., Jaros, M., Wijngaard, P. L. J., & Kastelein, J. J. P.
- Affiliations
- Mayo Clinic (US)
- From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of...
- St. Michael's Hospital (CA)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2020-04-16
- Volume
- 382
- Issue
- 16
- Pages
- 1507-1519
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3012265841
- Semantic Scholar
- 0c86cfdc39f60ff6dc8854a281c1b95f32bdc692
- Cited by
- 1,665
- References
- 19
- Citations by year
- 2026: 296 · 2025: 290 · 2024: 289 · 2023: 273 · 2022: 231 · 2021: 193 · 2020: 87
- FWCI
- 183.81
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, other-oa)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- Spiral (Imperial College London) (submittedVersion)
- Funders
- The Medicines Company
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › Cholesterol and Lipid Metabolism
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Keywords
- inclisiran, PCSK9 inhibition, LDL cholesterol lowering, atherosclerotic cardiovascular disease, statin therapy, injection-site adverse events, hypercholesterolemia, lipid-lowering therapy, adverse events, drug safety and efficacy
- MeSH terms
- Proprotein Convertase 9, PCSK9 Inhibitors, Aged, Aged, 80 and over, Anticholesteremic Agents, Cardiovascular Diseases, Coronary Artery Disease, Double-Blind Method, Drug Administration Schedule, Female, Humans, Hypercholesterolemia, Injections, Subcutaneous, Cholesterol, LDL, Liver Function Tests, Male, Middle Aged, Risk Factors, Hydroxymethylglutaryl-CoA Reductase Inhibitors, RNA, Small Interfering
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