Inclisiran Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated: May 7, 2026

The clinical evidence base for Inclisiran comprises 42 peer-reviewed publications across 15 journals, 18 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Hypercholesterolemia, Hyperlipidemias, Metabolic Syndrome, and Atherosclerosis. Most recent publication: Efficacy and safety of inclisiran in adolescents with heterozygous familial hypercholesterolaemia (ORION-16): a two-part, randomised, multicentre clinical trial., Lancet Diabetes Endocrinol, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

Evaluating the implementation of inclisiran in primary care: process evaluation interim findings from interviews with key stakeholders.
Wilson P, Elvey R, Mathieson A, et al. · BMJ Open · 2025
PubMed: PMID 40010816 · NCT04807400 (SPIRIT) · Atherosclerosis
Efficacy and Safety of Inclisiran in Adolescents With Genetically Confirmed Homozygous Familial Hypercholesterolemia: Results From the Double-Blind, Placebo-Controlled Part of the ORION-13 Randomized Trial.
Wiegman A, Peterson AL, Hegele RA, et al. · Circulation · 2025
PubMed: PMID 40391436 · NCT04659863 (ORION-13) · Homozygous Familial Hypercholesterolemia
Efficacy and safety of inclisiran in adolescents with heterozygous familial hypercholesterolaemia (ORION-16): a two-part, randomised, multicentre clinical trial.
Wiegman A, Peterson AL, Bruckert E, et al. · Lancet Diabetes Endocrinol · 2026
PubMed: PMID 41616799 · NCT04652726 (ORION-16)
Safety and Lipid-Lowering Efficacy of Inclisiran Monotherapy in Patients Without ASCVD: The VICTORION-Mono Randomized Clinical Trial.
Taub PR, Gutierrez A, Wewers D, et al. · J Am Coll Cardiol · 2025
PubMed: PMID 40392667 · NCT05763875 (V-Mono) · Hypercholesterolemia
Design and rationale of a randomized clinical trial assessing the effect of inclisiran on atherosclerotic plaque in individuals without previous cardiovascular event and without flow- limiting lesions identified in an in-hospital screening: The VICTORION-PLAQUE primary prevention trial.
Revaiah PC, Serruys PW, Onuma Y, et al. · Am Heart J · 2025
PubMed: PMID 40769373 · NCT05360446 (V-PLAQUE) · Coronary Artery Disease
Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol.
Ray KK, Wright RS, Kallend D, et al. · N Engl J Med · 2020
PubMed: PMID 32187462 · NCT03400800 (ORION-11) · Hypercholesterolemia
Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial.
Ray KK, Troquay RPT, Visseren FLJ, et al. · Lancet Diabetes Endocrinol · 2023
PubMed: PMID 36620965 · NCT03060577 (ORION-3) · Atherosclerosis
Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia.
Raal FJ, Kallend D, Ray KK, et al. · N Engl J Med · 2022
PubMed: PMID 32197277 · NCT03397121 (ORION-9) · Hypercholesterolemia

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

Trial	Indication	Primary endpoint	Arm	Value
NCT03397121 ORION-9	Hypercholesterolemia	Percent Change in LDL-C From Baseline To Day 510 Baseline, Day 510	Inclisiran	-41.15 percent change
NCT03397121 ORION-9	Hypercholesterolemia		Placebo	8.37 percent change
NCT03397121 ORION-9	Hypercholesterolemia	Time-adjusted Percent Change in LDL-C From Baseline After Day 90 and up to Day 540 Baseline, Day 90	Inclisiran	-38.08 percent change
NCT03397121 ORION-9	Hypercholesterolemia		Placebo	6.22 percent change
NCT03399370 ORION-10	Hypercholesterolemia	Percentage Change in LDL-C From Baseline to Day 510 Baseline, Day 510	Inclisiran	-56.34 percent change
NCT03399370 ORION-10	Hypercholesterolemia		Placebo	1.30 percent change
NCT03399370 ORION-10	Hypercholesterolemia	Time-adjusted Percentage Change in LDL-C Levels From Baseline After Day 90 and up to Day 540 Baseline, Day 90 to Day 540	Inclisiran	-51.27 percent change
NCT03399370 ORION-10	Hypercholesterolemia		Placebo	2.51 percent change
NCT03400800 ORION-11	Hypercholesterolemia	Percentage Change in LDL-C From Baseline to Day 510 Baseline, Day 510	Inclisiran	-49.3 Percent change
NCT03400800 ORION-11	Hypercholesterolemia		Placebo	4.2 Percent change
NCT03400800 ORION-11	Hypercholesterolemia	Time-adjusted Percent Change in LDL-C Levels From Baseline After Day 90 and up to Day 540 Baseline, Day 90 to Day 540	Inclisiran	-45.82 Percent change
NCT03400800 ORION-11	Hypercholesterolemia		Placebo	3.35 Percent change
NCT03814187 ORION-8	Hypercholesterolemia	Incidence of Treatment-emergent Adverse Events (TEAEs) From ORION-8 Day 1 to the end of study (up to 1080 days)	ORION-3 Rollover	43 Participants
			ORION-3 Rollover	0 Participants
			ORION-3 Rollover	181 Participants
			ORION-3 Rollover	16 Participants
			ORION-3 Rollover	4 Participants
			ORION-3 Rollover	1 Participants
			Phase III Inclisiran-Inclisiran	0 Participants
			Phase III Inclisiran-Inclisiran	464 Participants
			Phase III Inclisiran-Inclisiran	80 Participants
			Phase III Inclisiran-Inclisiran	2 Participants
			Phase III Inclisiran-Inclisiran	133 Participants
			Phase III Inclisiran-Inclisiran	1197 Participants
			Phase III Placebo-Inclisiran	81 Participants
			Phase III Placebo-Inclisiran	0 Participants
			Phase III Placebo-Inclisiran	148 Participants
			Phase III Placebo-Inclisiran	1170 Participants
			Phase III Placebo-Inclisiran	2 Participants
			Phase III Placebo-Inclisiran	482 Participants
			Total	0 Participants
			Total	2548 Participants
			Total	297 Participants
			Total	989 Participants
			Total	5 Participants
			Total	165 Participants
NCT03814187 ORION-8	Hypercholesterolemia	Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk From ORION-8 Day 1 to the end of study (up to 1080 days)	ORION-3 Rollover	77.00 Percentage of participants
			ORION-3 Rollover	76.70 Percentage of participants
			ORION-3 Rollover	76.81 Percentage of participants
			Phase III Inclisiran-Inclisiran	79.34 Percentage of participants
			Phase III Inclisiran-Inclisiran	72.56 Percentage of participants
			Phase III Inclisiran-Inclisiran	78.18 Percentage of participants
			Phase III Placebo-Inclisiran	74.88 Percentage of participants
			Phase III Placebo-Inclisiran	79.07 Percentage of participants
			Phase III Placebo-Inclisiran	79.96 Percentage of participants
			Total	79.41 Percentage of participants
			Total	78.43 Percentage of participants
			Total	74.33 Percentage of participants
NCT03851705 ORION-5	Homozygous Familial Hypercholesterolemia	Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150 Baseline, Day 150	Part 1 - Inclisiran	0.70 Percentage change
NCT03851705 ORION-5	Homozygous Familial Hypercholesterolemia		Part 1 - Placebo	2.39 Percentage change
NCT04652726 ORION-16	—	Percentage Change in LDL-C From Baseline to Day 330 (Part 1/Year 1) Baseline and Day 330	Part 1- Inclisiran	-27.14 percent change in LDL-C
NCT04652726 ORION-16	—		Part 1 - Placebo	1.40 percent change in LDL-C
NCT04659863 ORION-13	Homozygous Familial Hypercholesterolemia	Percentage Change in LDL-C From Baseline to Day 330 (Part 1/Year 1) Baseline and Day 330	Part 1- Inclisiran	-21.6 percent change in LDL-C (±13.36 Standard Deviation)
NCT04659863 ORION-13	Homozygous Familial Hypercholesterolemia		Part 1 - Placebo	11.7 percent change in LDL-C (±30.52 Standard Deviation)
NCT04807400 SPIRIT	Atherosclerosis	Percentage Change in LDL-C From Baseline to Day 270 Baseline, Day 270	Control+ BS	-5.4 percent change from baseline in LDL-C (±2.34 Standard Error)
			Inclisiran	-37.3 percent change from baseline in LDL-C (±2.29 Standard Error)
			Inclisiran + BS	-37.6 percent change from baseline in LDL-C (±2.33 Standard Error)
NCT04873934 V-INCEPTION	Hypercholesterolemia	Achievement of LDL-C < 70 mg/dL at Day 330 Day 330	Inclisiran With Usual Care	66.7 Percentage of participants
NCT04873934 V-INCEPTION	Hypercholesterolemia	Achievement of LDL-C < 70 mg/dL at Day 330 Day 330	Usual Care	28.1 Percentage of participants
NCT04873934 V-INCEPTION	Hypercholesterolemia	Percent Change From Baseline to Day 330 in LDL-C Baseline and Day 330	Inclisiran With Usual Care	-45.6 Percent change in LDL-C
NCT04873934 V-INCEPTION	Hypercholesterolemia		Usual Care	1.4 Percent change in LDL-C
NCT04929249 V-INITIATE	Hypercholesterolemia	Percent Change From Baseline in LDL-C Baseline, Day 330	Inclisiran First	-60.0 percent change in LDL-C
NCT04929249 V-INITIATE	Hypercholesterolemia	Percent Change From Baseline in LDL-C Baseline, Day 330	Usual Care	-7.0 percent change in LDL-C
NCT04929249 V-INITIATE	Hypercholesterolemia	Percentage of Participants Who Discontinued Statin Therapy Day 330	Inclisiran First	6.0 Percentage of participants
NCT04929249 V-INITIATE	Hypercholesterolemia		Usual Care	16.7 Percentage of participants
NCT05763875 V-Mono	Hypercholesterolemia	Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150 Baseline, Day 150	Ezetimibe	-11.17 Percentage change from baseline
			Ezetimibe	-11.92 Percentage change from baseline
			Inclisiran	-46.54 Percentage change from baseline
			Inclisiran	-49.37 Percentage change from baseline
			Placebo	1.37 Percentage change from baseline
			Placebo	-1.53 Percentage change from baseline
NCT05888103 V-Mono China	Hypercholesterolemia	Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part Baseline, Day 150	Inclisiran - Inclisiran	-45.87 % change in LDL-C
NCT05888103 V-Mono China	Hypercholesterolemia		Placebo- Inclisiran	1.62 % change in LDL-C

Publications by year

1999–2026: 42 publications.

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Publications by indication

Hypercholesterolemia (15)

Safety and Lipid-Lowering Efficacy of Inclisiran Monotherapy in Patients Without ASCVD: The VICTORION-Mono Randomized Clinical Trial.
J Am Coll Cardiol · 2025 · PMID 40392667 · NCT05763875
Design and rationale of the VICTORION-Difference study: A phase 4 randomized, double-blind, placebo-controlled clinical trial to assess inclisiran's early efficacy, safety, tolerability, as well as its impact on quality of life in individuals with hypercholesterolemia.
Am Heart J · 2025 · PMID 40436308 · NCT05192941
Effects of Inclisiran in Patients With Atherosclerotic Cardiovascular Disease: A Pooled Analysis of the ORION-10 and ORION-11 Randomized Trials.
Mayo Clin Proc · 2024 · PMID 39093262 · NCT03400800
Inclisiran administration potently and durably lowers LDL-C over an extended-term follow-up: the ORION-8 trial.
Cardiovasc Res · 2024 · PMID 38753448 · NCT03814187
An "Inclisiran First" Strategy vs Usual Care in Patients With Atherosclerotic Cardiovascular Disease.
J Am Coll Cardiol · 2024 · PMID 38593947 · NCT04929249

Hyperlipidemias (9)

Effect of evolocumab on the progression of intraplaque neovascularization of the carotid based on contrast-enhanced ultrasonography (EPIC study): A prospective single-arm, open-label study.
Front Pharmacol · 2024 · PMID 36686711 · NCT06586684
The clinical effects of inclisiran, a first-in-class LDL-C lowering siRNA therapy, on the LDL-C levels in Chinese patients with hypercholesterolemia.
J Clin Lipidol · 2023 · PMID 37164838 · NCT04774003
Effect of PCSK9 inhibition in combination with statin therapy on intracranial atherosclerotic stenosis: A high-resolution MRI study.
Front Aging Neurosci · 2023 · PMID 36967822 · NCT06586684
Effect of inclisiran on lipids in primary prevention: the ORION-11 trial.
Eur Heart J · 2022 · PMID 36331315 · NCT06586684
Pooled Patient-Level Analysis of Inclisiran Trials in Patients With Familial Hypercholesterolemia or Atherosclerosis.
J Am Coll Cardiol · 2021 · PMID 33663735 · NCT06586684

Metabolic Syndrome (8)

Prevalence of Drug-Drug Interactions in Older Community-Dwelling Individuals: A Systematic Review and Meta-analysis.
Drugs Aging · 2023 · PMID 36692678 · NCT06865885
When Does a Calcium Score Equate to Secondary Prevention?: Insights From the Multinational CONFIRM Registry.
JACC Cardiovasc Imaging · 2023 · PMID 37227328 · NCT06865885
10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes-2024.
Diabetes Care · 2023 · PMID 38078592 · NCT06865885
Cardiovascular Implications of Immune Disorders in Women.
Circ Res · 2022 · PMID 35175848 · NCT06865885
Breast Arterial Calcification: a Novel Cardiovascular Risk Enhancer Among Postmenopausal Women.
Circ Cardiovasc Imaging · 2022 · PMID 35290077 · NCT06865885

Atherosclerosis (3)

Evaluating the implementation of inclisiran in primary care: process evaluation interim findings from interviews with key stakeholders.
BMJ Open · 2025 · PMID 40010816 · NCT04807400
Development and application of a qualitative rapid analysis framework in a hybrid trial within primary care.
BMJ Open · 2024 · PMID 39053958 · NCT04807400
Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial.
Lancet Diabetes Endocrinol · 2023 · PMID 36620965 · NCT03060577

Homozygous Familial Hypercholesterolemia (3)

Efficacy and Safety of Inclisiran in Adolescents With Genetically Confirmed Homozygous Familial Hypercholesterolemia: Results From the Double-Blind, Placebo-Controlled Part of the ORION-13 Randomized Trial.
Circulation · 2025 · PMID 40391436 · NCT04659863
Efficacy, Safety, and Tolerability of Inclisiran in Patients With Homozygous Familial Hypercholesterolemia: Results From the ORION-5 Randomized Clinical Trial.
Circulation · 2024 · PMID 37850379 · NCT03851705
Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins.
J Cardiovasc Pharmacol · 2022 · PMID 33990512 · NCT04659863

Renal Insufficiency (1)

Effects of Renal Impairment on the Pharmacokinetics, Efficacy, and Safety of Inclisiran: An Analysis of the ORION-7 and ORION-1 Studies.
Mayo Clin Proc · 2020 · PMID 31630870 · NCT03159416

Publications by journal

Circulation4 papers
J Am Coll Cardiol4 papers
Am Heart J3 papers
N Engl J Med3 papers
Mayo Clin Proc2 papers
BMJ Open2 papers
Lancet Diabetes Endocrinol2 papers
Eur J Prev Cardiol2 papers
Cardiovasc Res1 paper
J Cardiovasc Pharmacol1 paper

Trial-results highlights

Clinical trials investigated the effects of Inclisiran in individuals with hypercholesterolemia. In the NCT03397121 (ORION-9) study, the Inclisiran arm showed a -41.15 percent change in LDL-C from baseline to Day 510, while the placebo arm showed an 8.37 percent change. For time-adjusted percent change in LDL-C from baseline after Day 90 and up to Day 540, the Inclisiran arm reported a -38.08 percent change, and the placebo arm reported a 6.22 percent change.

Further studies also examined LDL-C levels. In NCT03399370 (ORION-10), the Inclisiran arm demonstrated a -56.34 percent change in LDL-C from baseline to Day 510, compared to a 1.30 percent change in the placebo arm. The time-adjusted percentage change in LDL-C from baseline after Day 90 and up to Day 540 was -51.27 percent change for the Inclisiran arm and 2.51 percent change for the placebo arm. Similarly, in NCT03400800 (ORION-11), the Inclisiran arm showed a -49.3 percent change in LDL-C from baseline to Day 510, versus a 4.2 percent change in the placebo arm. The time-adjusted percent change in LDL-C from baseline after Day 90 and up to Day 540 was -45.82 percent change for the Inclisiran arm and 3.35 percent change for the placebo arm.

The NCT03814187 (ORION-8) study investigated additional outcomes. The incidence of treatment-emergent adverse events (TEAEs) in the ORION-3 Rollover arm included:

43 participants
0 participants
181 participants
16 participants
4 participants
1 participant

The proportion of subjects achieving global lipid targets for their level of ASCVD risk was also measured. In the ORION-3 Rollover arm, these percentages were 77.00 percent, 76.70 percent, and 76.81 percent. In the Phase III Inclisiran-Inclisiran arm, the percentages were 79.34 percent, 72.56 percent, and 78.18 percent. All values are sourced from primary registry reporting; individual papers should be consulted for clinical decisions.

All Inclisiran publications (42)

2026 (1 paper)

Efficacy and safety of inclisiran in adolescents with heterozygous familial hypercholesterolaemia (ORION-16): a two-part, randomised, multicentre clinical trial.
Wiegman A, Peterson AL, Bruckert E, et al. · Lancet Diabetes Endocrinol · 2026 · Derived
PubMed: PMID 41616799 · NCT04652726 (ORION-16)

2025 (5 papers)

Evaluating the implementation of inclisiran in primary care: process evaluation interim findings from interviews with key stakeholders.
Wilson P, Elvey R, Mathieson A, et al. · BMJ Open · 2025 · Derived
PubMed: PMID 40010816 · NCT04807400 (SPIRIT) · Atherosclerosis
Efficacy and Safety of Inclisiran in Adolescents With Genetically Confirmed Homozygous Familial Hypercholesterolemia: Results From the Double-Blind, Placebo-Controlled Part of the ORION-13 Randomized Trial.
Wiegman A, Peterson AL, Hegele RA, et al. · Circulation · 2025 · Derived
PubMed: PMID 40391436 · NCT04659863 (ORION-13) · Homozygous Familial Hypercholesterolemia
Safety and Lipid-Lowering Efficacy of Inclisiran Monotherapy in Patients Without ASCVD: The VICTORION-Mono Randomized Clinical Trial.
Taub PR, Gutierrez A, Wewers D, et al. · J Am Coll Cardiol · 2025 · Derived
PubMed: PMID 40392667 · NCT05763875 (V-Mono) · Hypercholesterolemia
Design and rationale of a randomized clinical trial assessing the effect of inclisiran on atherosclerotic plaque in individuals without previous cardiovascular event and without flow- limiting lesions identified in an in-hospital screening: The VICTORION-PLAQUE primary prevention trial.
Revaiah PC, Serruys PW, Onuma Y, et al. · Am Heart J · 2025 · Derived
PubMed: PMID 40769373 · NCT05360446 (V-PLAQUE) · Coronary Artery Disease
Design and rationale of the VICTORION-Difference study: A phase 4 randomized, double-blind, placebo-controlled clinical trial to assess inclisiran's early efficacy, safety, tolerability, as well as its impact on quality of life in individuals with hypercholesterolemia.
Landmesser U, Laufs U, Schatz U, et al. · Am Heart J · 2025 · Derived
PubMed: PMID 40436308 · NCT05192941 (V-DIFFERENCE) · Hypercholesterolemia

2024 (10 papers)

Effects of Inclisiran in Patients With Atherosclerotic Cardiovascular Disease: A Pooled Analysis of the ORION-10 and ORION-11 Randomized Trials.
Wright RS, Ray KK, Landmesser U, et al. · Mayo Clin Proc · 2024 · Derived
PubMed: PMID 39093262 · NCT03400800 (ORION-11) · Hypercholesterolemia
Inclisiran administration potently and durably lowers LDL-C over an extended-term follow-up: the ORION-8 trial.
Wright RS, Raal FJ, Koenig W, et al. · Cardiovasc Res · 2024 · Derived
PubMed: PMID 38753448 · NCT03814187 (ORION-8) · Hypercholesterolemia
Efficacy, Safety, and Tolerability of Inclisiran in Patients With Homozygous Familial Hypercholesterolemia: Results From the ORION-5 Randomized Clinical Trial.
Raal F, Durst R, Bi R, et al. · Circulation · 2024 · Derived
PubMed: PMID 37850379 · NCT03851705 (ORION-5) · Homozygous Familial Hypercholesterolemia
Development and application of a qualitative rapid analysis framework in a hybrid trial within primary care.
Mathieson A, Elvey R, Wilson P, et al. · BMJ Open · 2024 · Derived
PubMed: PMID 39053958 · NCT04807400 (SPIRIT) · Atherosclerosis
An "Inclisiran First" Strategy vs Usual Care in Patients With Atherosclerotic Cardiovascular Disease.
Koren MJ, Rodriguez F, East C, et al. · J Am Coll Cardiol · 2024 · Derived
PubMed: PMID 38593947 · NCT04929249 (V-INITIATE) · Hypercholesterolemia
Efficacy and Safety of Inclisiran in Asian Patients: Results From ORION-18.
Huo Y, Lesogor A, Lee CW, et al. · JACC Asia · 2024 · Derived
PubMed: PMID 38371290 · NCT04765657 · Hypercholesterolemia
A systematic review and meta-analysis of tolerability, cardiac safety and efficacy of inclisiran for the therapy of hyperlipidemic patients.
Dutta S, Shah R, Singhal S, et al. · Expert Opin Drug Saf · 2024 · Derived
PubMed: PMID 38063346 · NCT03397121 (ORION-9) · Hypercholesterolemia
In-silico trial emulation to predict the cardiovascular protection of new lipid-lowering drugs: an illustration through the design of the SIRIUS programme.
Angoulvant D, Granjeon-Noriot S, Amarenco P, et al. · Eur J Prev Cardiol · 2024 · Derived
PubMed: PMID 39101472 · NCT05974345 (SIRIUS) · Hypercholesterolemia
Achievement of LDL-C <55 mg/dL among US adults: Findings from the cvMOBIUS2 registry.
Navar AM, Shah NP, Shrader P, et al. · Am Heart J · 2024 · Background
PubMed: PMID 38972336 · NCT06909565 (V-INTERVENTION) · Hypercholesterolemia
Effect of evolocumab on the progression of intraplaque neovascularization of the carotid based on contrast-enhanced ultrasonography (EPIC study): A prospective single-arm, open-label study.
Chen J, Zhao F, Lei C, et al. · Front Pharmacol · 2024 · Background
PubMed: PMID 36686711 · NCT06586684 · Hyperlipidemias

2023 (7 papers)

Plain language summary of results from ORION-10 and ORION-11: two studies to learn how well inclisiran works in people with high cholesterol.
Ray KK, Wright RS · Future Cardiol · 2023 · Derived
PubMed: PMID 37282500 · NCT03399370 (ORION-10) · Hypercholesterolemia
Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial.
Ray KK, Troquay RPT, Visseren FLJ, et al. · Lancet Diabetes Endocrinol · 2023 · Derived
PubMed: PMID 36620965 · NCT03060577 (ORION-3) · Atherosclerosis
The clinical effects of inclisiran, a first-in-class LDL-C lowering siRNA therapy, on the LDL-C levels in Chinese patients with hypercholesterolemia.
Luo Z, Huang Z, Sun F, et al. · J Clin Lipidol · 2023 · Derived
PubMed: PMID 37164838 · NCT04774003 (ORION-14) · Hyperlipidemias
Effect of PCSK9 inhibition in combination with statin therapy on intracranial atherosclerotic stenosis: A high-resolution MRI study.
Wu L, Kong Q, Huang H, et al. · Front Aging Neurosci · 2023 · Background
PubMed: PMID 36967822 · NCT06586684 · Hyperlipidemias
Prevalence of Drug-Drug Interactions in Older Community-Dwelling Individuals: A Systematic Review and Meta-analysis.
Hughes JE, Waldron C, Bennett KE, et al. · Drugs Aging · 2023 · Background
PubMed: PMID 36692678 · NCT06865885 (SOLVE-LDL-C) · Metabolic Syndrome
When Does a Calcium Score Equate to Secondary Prevention?: Insights From the Multinational CONFIRM Registry.
Budoff MJ, Kinninger A, Gransar H, et al. · JACC Cardiovasc Imaging · 2023 · Background
PubMed: PMID 37227328 · NCT06865885 (SOLVE-LDL-C) · Metabolic Syndrome
10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes-2024.
American Diabetes Association Professional Practice Committee · Diabetes Care · 2023 · Background
PubMed: PMID 38078592 · NCT06865885 (SOLVE-LDL-C) · Metabolic Syndrome

2022 (6 papers)

Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins.
Warden BA, Duell PB · J Cardiovasc Pharmacol · 2022 · Derived
PubMed: PMID 33990512 · NCT04659863 (ORION-13) · Homozygous Familial Hypercholesterolemia
Rationale and design of two trials assessing the efficacy, safety, and tolerability of inclisiran in adolescents with homozygous and heterozygous familial hypercholesterolaemia.
Reijman MD, Schweizer A, Peterson ALH, et al. · Eur J Prev Cardiol · 2022 · Derived
PubMed: PMID 35175352 · NCT04652726 (ORION-16)
Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia.
Raal FJ, Kallend D, Ray KK, et al. · N Engl J Med · 2022 · Derived
PubMed: PMID 32197277 · NCT03397121 (ORION-9) · Hypercholesterolemia
Effect of inclisiran on lipids in primary prevention: the ORION-11 trial.
Ray KK, Kallend D, Leiter LA, et al. · Eur Heart J · 2022 · Background
PubMed: PMID 36331315 · NCT06586684 · Hyperlipidemias
Cardiovascular Implications of Immune Disorders in Women.
Moran CA, Collins LF, Beydoun N, et al. · Circ Res · 2022 · Background
PubMed: PMID 35175848 · NCT06865885 (SOLVE-LDL-C) · Metabolic Syndrome
Breast Arterial Calcification: a Novel Cardiovascular Risk Enhancer Among Postmenopausal Women.
Iribarren C, Chandra M, Lee C, et al. · Circ Cardiovasc Imaging · 2022 · Background
PubMed: PMID 35290077 · NCT06865885 (SOLVE-LDL-C) · Metabolic Syndrome

2021 (2 papers)

Pooled Patient-Level Analysis of Inclisiran Trials in Patients With Familial Hypercholesterolemia or Atherosclerosis.
Wright RS, Ray KK, Raal FJ, et al. · J Am Coll Cardiol · 2021 · Background
PubMed: PMID 33663735 · NCT06586684 · Hyperlipidemias
CARotid plaqUe StabilizatiOn and regression with evolocumab: Rationale and design of the CARUSO study.
Aranzulla TC, Piazza S, Ricotti A, et al. · Catheter Cardiovasc Interv · 2021 · Background
PubMed: PMID 33893754 · NCT06586684 · Hyperlipidemias

2020 (4 papers)

Effects of Renal Impairment on the Pharmacokinetics, Efficacy, and Safety of Inclisiran: An Analysis of the ORION-7 and ORION-1 Studies.
Wright RS, Collins MG, Stoekenbroek RM, et al. · Mayo Clin Proc · 2020 · Derived
PubMed: PMID 31630870 · NCT03159416 · Renal Insufficiency
Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol.
Ray KK, Wright RS, Kallend D, et al. · N Engl J Med · 2020 · Derived
PubMed: PMID 32187462 · NCT03400800 (ORION-11) · Hypercholesterolemia
Carotid intraplaque neovascularization predicts coronary artery disease and cardiovascular events.
Mantella LE, Colledanchise KN, Hétu MF, et al. · Eur Heart J Cardiovasc Imaging · 2020 · Background
PubMed: PMID 31621834 · NCT06586684 · Hyperlipidemias
PCSK9 Inhibitor Use in the Real World: Data From the National Patient-Centered Research Network.
Chamberlain AM, Gong Y, Shaw KM, et al. · J Am Heart Assoc · 2020 · Background
PubMed: PMID 31020929 · NCT06909565 (V-INTERVENTION) · Hypercholesterolemia

2018 (1 paper)

Recommendations for Management of Clinically Significant Drug-Drug Interactions With Statins and Select Agents Used in Patients With Cardiovascular Disease: A Scientific Statement From the American Heart Association.
Wiggins BS, Saseen JJ, Page RL, et al. · Circulation · 2018 · Background
PubMed: PMID 27754879 · NCT06865885 (SOLVE-LDL-C) · Metabolic Syndrome

2017 (1 paper)

Detection of Atherosclerotic Inflammation by 68Ga-DOTATATE PET Compared to [18F]FDG PET Imaging.
Tarkin JM, Joshi FR, Evans NR, et al. · J Am Coll Cardiol · 2017 · Background
PubMed: PMID 28385306 · NCT04073797 (PIILL) · Hypercholesterolemia

2015 (1 paper)

64Cu-DOTATATE PET/MRI for Detection of Activated Macrophages in Carotid Atherosclerotic Plaques: Studies in Patients Undergoing Endarterectomy.
Pedersen SF, Sandholt BV, Keller SH, et al. · Arterioscler Thromb Vasc Biol · 2015 · Background
PubMed: PMID 25977567 · NCT04073797 (PIILL) · Hypercholesterolemia

2013 (1 paper)

Evaluation of distal turbulence intensity for the detection of both plaque ulceration and stenosis grade in the carotid bifurcation using clinical Doppler ultrasound.
Wong EY, Nikolov HN, Rankin RN, et al. · Eur Radiol · 2013 · Background
PubMed: PMID 23247808 · NCT06586684 · Hyperlipidemias

2007 (1 paper)

Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial.
Crouse JR, Raichlen JS, Riley WA, et al. · JAMA · 2007 · Background
PubMed: PMID 17384434 · NCT06586684 · Hyperlipidemias

2003 (1 paper)

Mitral annular calcification predicts cardiovascular morbidity and mortality: the Framingham Heart Study.
Fox CS, Vasan RS, Parise H, et al. · Circulation · 2003 · Background
PubMed: PMID 12654605 · NCT06865885 (SOLVE-LDL-C) · Metabolic Syndrome

1999 (1 paper)

Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly.
Otto CM, Lind BK, Kitzman DW, et al. · N Engl J Med · 1999 · Background
PubMed: PMID 10403851 · NCT06865885 (SOLVE-LDL-C) · Metabolic Syndrome

Sources and methodology

Publications: ctgov.study_references (PubMed PMIDs auto-attached by ClinicalTrials.gov to each trial), reference types RESULT, DERIVED, and BACKGROUND.
Per-arm outcome values: ctgov.outcome_measurements joined to ctgov.design_outcomes where outcome_type = 'PRIMARY', restricted to phase PHASE3 and PHASE2/PHASE3.
Publication metadata (title, journal, year, authors): PubMed E-utilities efetch.fcgi
Data freshness: Thu, 07 May 2026 20:05:07 GMT.

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).