Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events
NCT ID: NCT05537571
Last Updated: 2025-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2022-12-13
2024-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SLN360 300 mg Q16W
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
SLN360
SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
SLN360 300 mg Q24W
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360
SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
SLN360 450 mg Q24W
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360
SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
Placebo Q16W
Placebo administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
Placebo
Sodium chloride, solution for injection
Placebo Q24W
Placebo administered subcutaneously at Weeks 0 and 24 (Q24W). This group was stratified so that half of participants were dosed to match the SLN360 300 mg Q24W group and half were dosed to match the SLN360 450 mg Q24W group (with respect to injected volume)
Placebo
Sodium chloride, solution for injection
Interventions
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SLN360
SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
Placebo
Sodium chloride, solution for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At high risk of ASCVD events
* A body mass index at screening in the range of 18.0 to 32.0 kg/m², inclusive
Exclusion Criteria
* History or clinical evidence of hepatic dysfunction
* Malignancy within the 5 years before screening
* Fasting triglycerides \>400 mg/dL (4.5 mmol/L) at screening
* Currently receiving or \<12 weeks at Day 1 since receiving \>200 mg/day niacin or niacin derivative drugs
* Treatment with lipid/lipoprotein apheresis within the 12 weeks before screening
* Any previous use of approved or experimental small interfering RNA (siRNA) therapy (e.g. inclisiran). NB: use of messenger RNA (mRNA) based vaccines for infectious diseases is permitted
18 Years
80 Years
ALL
No
Sponsors
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Silence Therapeutics plc
INDUSTRY
Responsible Party
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Locations
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Royal Adelaide Hospital
Adelaide, , Australia
Monash Health
Melbourne, , Australia
Linear Clinical Research
Nedlands, , Australia
Medicus Services SRO
Brandýs nad Labem, , Czechia
Edumed s.r.o., Kardiologicka, endokrinologicka, diabetologicka a interni ambulance Nachod
Náchod, , Czechia
Pratia Pardubice a.s.
Pardubice, , Czechia
Endokrinologie Cerny Most s.r.o.
Prague, , Czechia
Gentofte Hospital
Hellerup, , Denmark
Regionshospitalet Godstrup
Herning, , Denmark
Viborg Regional Hospital
Viborg, , Denmark
Academic Medical Center - Department of Vascular Medicine
Amsterdam, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Bravis Ziekenhuis - Bergen op Zoom
Roosendaal, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
VieCuri Medisch Centrum
Venlo, , Netherlands
Alian, s.r.o., Kardiologicka ambulancia
Bardejov, , Slovakia
Kardiomed s.r.o.
Lučenec, , Slovakia
Iatros International
Bloemfontein, , South Africa
Tiervlei Trial Centre (TTC)
Cape Town, , South Africa
TREAD Research - Department of Cardiology
Cape Town, , South Africa
University of Cape Town - Lipid Laboratory
Cape Town, , South Africa
Paarl Research Centre
Paarl, , South Africa
Dr JM Engelbrecht Trial Site
Somerset West, , South Africa
Helderberg Research Institute
Somerset West, , South Africa
Royal Sussex County Hospital
Brighton, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
Panthera - London North
London, , United Kingdom
Panthera - Manchester
Rochdale, , United Kingdom
Panthera - Sheffield
Sheffield, , United Kingdom
Countries
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References
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Nissen SE, Wang Q, Nicholls SJ, Navar AM, Ray KK, Schwartz GG, Szarek M, Stroes ESG, Troquay R, Dorresteijn JAN, Fok H, Rider DA, Romano S, Wolski K, Rambaran C. Zerlasiran-A Small-Interfering RNA Targeting Lipoprotein(a): A Phase 2 Randomized Clinical Trial. JAMA. 2024 Dec 17;332(23):1992-2002. doi: 10.1001/jama.2024.21957.
Nicholls SJ. Therapeutic lowering of lipoprotein(a): implications for improving outcomes in patients with peripheral arterial disease. Curr Opin Lipidol. 2025 Oct 1;36(5):232-237. doi: 10.1097/MOL.0000000000001002. Epub 2025 Jul 21.
Nicholls SJ, Nelson AJ, Michael LF. Oral agents for lowering lipoprotein(a). Curr Opin Lipidol. 2024 Dec 1;35(6):275-280. doi: 10.1097/MOL.0000000000000953. Epub 2024 Sep 25.
Dimitriadis K, Theofilis P, Iliakis P, Pyrpyris N, Dri E, Sakalidis A, Soulaidopoulos S, Tsioufis P, Fragkoulis C, Chrysohoou C, Tsiachris D, Tsioufis K. Management of dyslipidemia in coronary artery disease: the present and the future. Coron Artery Dis. 2024 Sep 1;35(6):516-524. doi: 10.1097/MCA.0000000000001375. Epub 2024 Apr 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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PubMed Publication
Other Identifiers
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SLN360-002
Identifier Type: -
Identifier Source: org_study_id
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