Phase
Condition
Vascular Diseases
Atherosclerosis
Hypercholesterolemia
Treatment
Inclisiran sodium
BPA
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Fasting LDL-C ≥ 70 mg/dL at screening
Participants must be on a stable (≥ 4 weeks) and well-tolerated lipid-loweringregimen (with or without Ezetimibe [10mg]) that must include a high-intensity statintherapy with either atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD in a maximallytolerated or maximally approved dose at screening
Participants categorized as very high or high CV risk, as defined below:
Very high risk participants with at least one of the following:
Documented ASCVD: ACS: Unstable angina or myocardial infarction, Stableangina, Coronary revascularization, Unequivocally documented ASCVD uponprior imaging, Stroke and Transient Ischaemic Attack (TIA), Peripheralartery disease (PAD)
Diabetes mellitus (DM) with target organ damage (defined asmicroalbuminuria, retinopathy, or neuropathy), or at least ≥ 3 major riskfactors, or early onset of Type 1 DM of long duration (< 20 years)
A calculated SCORE2 ≥ 7.5 % for age < 50 years; SCORE2 ≥ 10 % for age 50-69 years; SCORE2-OP ≥ 15 % for age ≥ 70 years to estimate 10-year riskof fatal and non-fatal CVD
Pre-existing diagnosis of heterozygous familial hyper-cholesterolemia (HeFH) with ASCVD or with another major risk factor OR
High risk participants with at least one of the following:
Markedly elevated single risk factors, in particular total cholesterol > 310 mg/dL, LDL-C > 190 mg/dL, or blood pressure ≥ 180/110 mmHg
Pre-existing diagnosis of HeFH without other major risk factors
DM without target organ damage (defined as microalbuminuria, retinopathy,or neuropathy), with DM duration ≥ 10 years or other additional riskfactor
Moderate chronic kidney disease (eGFR 30-59 mL/min/1.73m2)
A calculated SCORE2 2.5 to < 7.5 % for age < 50 years; SCORE2 5 to < 10 %for age 50-69 years; SCORE2-OP 7.5 to < 15 % for age ≥ 70 years toestimate 10-year risk of fatal and non-fatal CVD as defined by thecardiovascular risk categories in the 2019 ESC/EAS guideline (Mach et al 2020), and updated SCORE2 and SCORE2-OP (Hageman et al 2021, de Vries etal 2021, Visseren et al 2021). Further details for documented ASCVD willbe provided in the protocol.
- Fasting triglyceride < 400 mg/dL at screening
Exclusion
Exclusion Criteria:
Acute coronary syndrome, ischemic stroke, peripheral arterial revascularizationprocedure or amputation due to atherosclerotic disease < 4 months prior to screeningvisit or V1.
Planned or expected cardiac, cerebrovascular or peripheral artery surgery orcoronary re-vascularization within 6 months after screening visit.
Heart failure NYHA class IV at screening or V1.
Participants on more than one other lipid-lowering drug on top of statin atscreening visit.
Previous treatment with a mAb directed towards PCSK9 (e.g., evolocumab, alirocumab)or planned use after screening visit.
Previous treatment prior to screening with BPA within 90 days
Previous exposure to Inclisiran or any other non-mAb PCSK9-targeted therapy, eitheras an investigational or marketed drug.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Mannheim, Baden Wuerttemberg 68305
GermanySite Not Available
Novartis Investigative Site
Konstanz, Baden-Wuerttemberg 78464
GermanySite Not Available
Novartis Investigative Site
Regensburg, Bavaria 93053
GermanySite Not Available
Novartis Investigative Site
Lichtenfels, Bayern 96215
GermanySite Not Available
Novartis Investigative Site
Frankfurt Am Main, Hessen 60594
GermanySite Not Available
Novartis Investigative Site
Frankfurt am Main, Hessen 60590
GermanySite Not Available
Novartis Investigative Site
Goettingen, Niedersachsen 37075
GermanySite Not Available
Novartis Investigative Site
Koeln, Nordrhein-Westfalen 50733
GermanySite Not Available
Novartis Investigative Site
Loehne, Nordrhein-Westfalen 32584
GermanySite Not Available
Novartis Investigative Site
Kaiserslautern, Rheinland-Pfalz 67655
GermanySite Not Available
Novartis Investigative Site
Dresden, Sachsen 01099
GermanySite Not Available
Novartis Investigative Site
Leipzig, Sachsen 04209
GermanySite Not Available
Novartis Investigative Site
Aachen, 52074
GermanySite Not Available
Novartis Investigative Site
Bad Homburg, 61348
GermanySite Not Available
Novartis Investigative Site
Bad Krozingen, 79189
GermanySite Not Available
Novartis Investigative Site
Bad Oeynhausen, 32545
GermanySite Not Available
Novartis Investigative Site
Bamberg, 96049
GermanySite Not Available
Novartis Investigative Site
Berlin, 13347
GermanySite Not Available
Novartis Investigative Site
Bochum, 44791
GermanySite Not Available
Novartis Investigative Site
Bremen, 28277
GermanySite Not Available
Novartis Investigative Site
Dessau-Rosslau, 06846
GermanySite Not Available
Novartis Investigative Site
Dessau-Roßlau, 06846
GermanySite Not Available
Novartis Investigative Site
Erfurt, 99097
GermanySite Not Available
Novartis Investigative Site
Essen, 45355
GermanySite Not Available
Novartis Investigative Site
Falkensee, 14612
GermanySite Not Available
Novartis Investigative Site
Frankfurt, 60389
GermanySite Not Available
Novartis Investigative Site
Gladbeck, 45968
GermanySite Not Available
Novartis Investigative Site
Gottingen, 37075
GermanySite Not Available
Novartis Investigative Site
Greifswald, 17475
GermanySite Not Available
Novartis Investigative Site
Guetersloh, 33332
GermanySite Not Available
Novartis Investigative Site
Hamburg, 22041
GermanySite Not Available
Novartis Investigative Site
Hannover, 30625
GermanySite Not Available
Novartis Investigative Site
Herne, 44625
GermanySite Not Available
Novartis Investigative Site
Hoyerswerda, 02977
GermanySite Not Available
Novartis Investigative Site
Jena, 07740
GermanySite Not Available
Novartis Investigative Site
Kassel, 34121
GermanySite Not Available
Novartis Investigative Site
Kiel, 24105
GermanySite Not Available
Novartis Investigative Site
Koeln-Nippes, 50733
GermanySite Not Available
Novartis Investigative Site
Ludwigshafen, 67067
GermanySite Not Available
Novartis Investigative Site
Magdeburg, 39120
GermanySite Not Available
Novartis Investigative Site
Markkleeberg, 04416
GermanySite Not Available
Novartis Investigative Site
Meissen, 01662
GermanySite Not Available
Novartis Investigative Site
Muehldorf, 84453
GermanySite Not Available
Novartis Investigative Site
Muenster, 48149
GermanySite Not Available
Novartis Investigative Site
Offenbach Am Main, 63065
GermanySite Not Available
Novartis Investigative Site
Papenburg, 26871
GermanySite Not Available
Novartis Investigative Site
Pirna, 01796
GermanySite Not Available
Novartis Investigative Site
Potsdam, 14471
GermanySite Not Available
Novartis Investigative Site
Ruedersdorf, 15562
GermanySite Not Available
Novartis Investigative Site
Saint Ingbert Oberwuerzbach, 66386
GermanySite Not Available
Novartis Investigative Site
St. Ingbert Oberwuerzbach, 66386
GermanySite Not Available
Novartis Investigative Site
Stuttgart, 70376
GermanySite Not Available
Novartis Investigative Site
Sulzbach Rosenberg, 92237
GermanySite Not Available
Novartis Investigative Site
Ulm, 89077
GermanySite Not Available
Novartis Investigative Site
Voelklingen, 66333
GermanySite Not Available
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