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Clinical trials for inclisiran

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    15 result(s) found for: inclisiran. Displaying page 1 of 1.
    EudraCT Number: 2021-002006-27 Sponsor Protocol Number: CKJX839B12302 Start Date*: 2021-11-15
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, double-blind, placebo -controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease...
    Medical condition: Atherosclerotic cardiovascular disease (ASCVD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004866 10051615 Atherosclerotic cardiovascular disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) SK (Trial now transitioned) PT (Trial now transitioned) LT (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned) AT (Trial now transitioned) LV (Trial now transitioned) HU (Trial now transitioned) SE (Trial now transitioned) DK (Trial now transitioned) BE (Trial now transitioned) SI (Trial now transitioned) BG (Trial now transitioned) HR (Trial now transitioned) NO (Trial now transitioned) PL (Trial now transitioned) FI (Trial now transitioned) GR (Trial now transitioned) IS (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-003815-37 Sponsor Protocol Number: MDCO-PCS-16-01 Start Date*: 2017-02-24
    Sponsor Name:Novartis Pharma AG
    Full Title: An open label, active comparator extension trial to assess the effect of long term dosing of inclisiran and evolocumab given as subcutaneous injections in subjects with high cardiovascular risk and...
    Medical condition: Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004861 10020604 Hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) NL (Ongoing)
    Trial results: View results
    EudraCT Number: 2020-002755-38 Sponsor Protocol Number: CKJX839C12302 Start Date*: 2020-12-30
    Sponsor Name:Novartis Pharma AG
    Full Title: Two part (double-blind) inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2] randomized multicentre study to evaluate safety, tolerability, and efficacy of inclisiran in ad...
    Medical condition: Homozygous Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10057080 Homozygous familial hypercholesterolemia LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SI (Completed) GR (Completed) NL (Completed) FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002757-18 Sponsor Protocol Number: CKJX839C12301 Start Date*: 2020-12-21
    Sponsor Name:Novartis Pharma AG
    Full Title: Two part (double-blind inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2]) randomized multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in ad...
    Medical condition: Heterozygous Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10057079 Heterozygous familial hypercholesterolemia LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) NO (Completed) DE (Completed) SI (Completed) NL (Completed) GR (Completed) FR (Completed) IT (Completed) PL (Completed) HR (Completed) SK (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-001109-29 Sponsor Protocol Number: CKJX839D12304 Start Date*: 2022-12-06
    Sponsor Name:Novartis Pharma AG
    Full Title: A Double-blind, Randomized, Placebo- and Active-Comparator Controlled Study to Evaluate the Efficacy of Inclisiran as Monotherapy in Patients with Primary Hypercholesterolemia Not Receiving Lipid-L...
    Medical condition: Primary Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10077965 Primary hypercholesterolaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-002316-23 Sponsor Protocol Number: CKJX839C12001B Start Date*: 2023-01-16
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: An open-label, single arm, multicenter extension study to evaluate long-term safety and tolerability of inclisiran in participants with heterozygous or homozygous familial hypercholesterolemia who...
    Medical condition: Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10049593 Familial hypercholesterolaemia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Trial now transitioned) NO (Trial now transitioned) DE (Ongoing) NL (Trial now transitioned) HU (Trial now transitioned) GR (Trial now transitioned) FR (Trial now transitioned) SI (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-005066-22 Sponsor Protocol Number: CTSU_MDCO-PCS-17-01 Start Date*: 2018-06-11
    Sponsor Name:University of Oxford [...]
    1. University of Oxford
    2. The Medicines Company
    Full Title: HPS-4/TIMI 65/ORION-4: A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease
    Medical condition: Atherosclerotic cardiovascular disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004866 10051615 Atherosclerotic cardiovascular disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-003092-55 Sponsor Protocol Number: MDCO-PCS-17-05 Start Date*: 2019-02-05
    Sponsor Name:The Medicines Company
    Full Title: A long term extension trial of the Phase III lipid-lowering trials to assess the effect of long term dosing of inclisiran given as subcutaneous injections in subjects with high cardiovascular risk ...
    Medical condition: Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10020604 Hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) CZ (Completed) DE (Completed) SE (Completed) DK (Completed) HU (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2017-002472-30 Sponsor Protocol Number: MDCO-PCS-17-03 Start Date*: 2018-01-04
    Sponsor Name:The Medicines Company
    Full Title: A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL TO EVALUATE THE EFFECT OF 300 MG OF INCLISIRAN SODIUM GIVEN AS SUBCUTANEOUS INJECTIONS IN SUBJECTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEM...
    Medical condition: Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10020604 Hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) CZ (Completed) SE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2017-001846-90 Sponsor Protocol Number: MDCO-PCS-17-08 Start Date*: 2017-12-12
    Sponsor Name:The Medicines Company
    Full Title: A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL TO EVALUATE THE EFFECT OF 300 MG OF INCLISIRAN SODIUM GIVEN AS SUBCUTANEOUS INJECTIONS IN SUBJECTS WITH ATHEROSCLEROTIC CARDIOVASCULAR DISEASE (...
    Medical condition: Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10020604 Hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) GB (Completed) CZ (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2021-004601-47 Sponsor Protocol Number: CKJX839D12303 Start Date*: 2022-05-09
    Sponsor Name:NOVARTIS PHARMA AG
    Full Title: A multi-center, randomized, double-blind, placebo controlled, parallelgroup Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed ...
    Medical condition: Non-obstructive coronary artery disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10011078 Coronary artery disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) HU (Trial now transitioned) BE (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) IE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-003759-40 Sponsor Protocol Number: CKJX839A12402 Start Date*: 2022-02-14
    Sponsor Name:Novartis Pharma AG
    Full Title: Efficacy, safety, tolerability and quality of life of ongoing individually optimized  lipid-lowering therapy with or without inclisiran (KJX839) – a randomized, placebo-controlled, double-blind mul...
    Medical condition: Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004861 10020604 Hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Trial now transitioned) FR (Trial now transitioned) BG (Trial now transitioned) LV (Trial now transitioned) EE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-005602-10 Sponsor Protocol Number: 1.1 Start Date*: 2022-01-20
    Sponsor Name:Verein zur Förderung der Forschung auf dem Gebiet der Arteriosklerose, Thrombose und vaskulären Biologie (ATVB)
    Full Title: POESIA Study: Pleiotropic effects of PCSK 9 inhibition and bempedoic acid - Changes in Platelet Function and Inflammation Markers
    Medical condition: platelet activity and inflammation markers in patients with coronary artery disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-002871-20 Sponsor Protocol Number: LIB003-012 Start Date*: 2022-04-21
    Sponsor Name:LIB Therapeutics, LLC
    Full Title: Randomized, Open Label, Phase 3 Study to Evaluate the Efficacy and Safety of Lerodalcibep (LIB003) compared to Inclisiran in Patients With Cardiovascular Disease, or at High Risk for Cardiovascula...
    Medical condition: Patients with atherosclerotic cardiovascular (CV) disease (ASCVD) or high risk of ASCVD who need additional LDL-C reduction
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004849 10007648 Cardiovascular disease, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) NO (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-001000-42 Sponsor Protocol Number: 1144/2020 Start Date*: 2020-07-09
    Sponsor Name:Medical University of Vienna
    Full Title: The relationship of cholesterol-lowering drugs with steroid HORMONEs, bile acids, vitamin D, the immune system and related diseases such as depression and osteoporosis
    Medical condition: Patients with a diagnosed hyperlipidemia treated with statins (with either simvastatin <=20 mg, atorvastatin <=10 mg or rosuvastatin <=10 mg - random allocation), or with atorvastatin >=40 mg or r...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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