Cardiovascular DiseasesPhase 2NCT05537571

Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events

A Phase 2 study testing SLN360 in people with Cardiovascular Diseases and Atherosclerosis, run by Silence Therapeutics plc at 29 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Phase 2 study to evaluate the efficacy, safety and tolerability of SLN360 administered subcutaneously (SC) compared with placebo in adult participants with elevated lipoprotein(a) at high risk of atherosclerotic cardiovascular disease events Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Cardiovascular Diseases, Atherosclerosis, Lipoprotein(a)
What is being tested?: SLN360
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 29 sitesin 7 countries
Study dates: 13 Dec 2022to 1 Jul 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Lipoprotein(a) at screening equal to or greater than 125 nmol/L
At high risk of ASCVD events
A body mass index at screening in the range of 18.0 to 32.0 kg/m², inclusive

Who cannot join

Renal dysfunction with estimated glomerular filtration rate less than 30 mL/min/1.73 m² at screening
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

Trial locations and contacts

29 sites in 7 countries.

Country

City, postcode or hospital

29 sites in 7 countries

South Africa7 sites

Iatros International
Bloemfontein
Tiervlei Trial Centre (TTC)
Cape Town
TREAD Research - Department of Cardiology
Cape Town
University of Cape Town - Lipid Laboratory
Cape Town
Paarl Research Centre
Paarl
Dr JM Engelbrecht Trial Site
Somerset West
Helderberg Research Institute
Somerset West

Other trials in South Africa

Netherlands5 sites

Academic Medical Center - Department of Vascular Medicine
Amsterdam
Onze Lieve Vrouwe Gasthuis
Amsterdam
Bravis Ziekenhuis - Bergen op Zoom
Roosendaal
Universitair Medisch Centrum Utrecht
Utrecht
VieCuri Medisch Centrum
Venlo

Other trials in Netherlands

United Kingdom5 sites

Royal Sussex County Hospital
Brighton
Chelsea and Westminster Hospital
London
Panthera - London North
London
Panthera - Manchester
Rochdale
Panthera - Sheffield
Sheffield

Other trials in United Kingdom

Czechia4 sites

Medicus Services SRO
Brandýs nad Labem
Edumed s.r.o., Kardiologicka, endokrinologicka, diabetologicka a interni ambulance Nachod
Náchod
Pratia Pardubice a.s.
Pardubice
Endokrinologie Cerny Most s.r.o.
Prague

Other trials in Czechia

Australia3 sites

Royal Adelaide Hospital
Adelaide
Monash Health
Melbourne
Linear Clinical Research
Nedlands

Other trials in Australia

Denmark3 sites

Gentofte Hospital
Hellerup
Regionshospitalet Godstrup
Herning
Viborg Regional Hospital
Viborg

Other trials in Denmark

Slovakia2 sites

Alian, s.r.o., Kardiologicka ambulancia
Bardejov
Kardiomed s.r.o.
Lučenec

Other trials in Slovakia

About this study

Official title: A Multi-centre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study to Investigate Efficacy, Safety and Tolerability of SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events

Conditions: Cardiovascular Diseases, Atherosclerosis, Lipoprotein(a)
Being tested: SLN360, Placebo
Keywords: Cardiovascular Diseases, Atherosclerosis, Lipoprotein(a)
Medical subject headings: Cardiovascular Diseases, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SLN360Drug
Also called Zerlasiran
SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
PlaceboDrug
Sodium chloride, solution for injection

Study groups in NCT05537571
Study group	Role	What they receive
SLN360 300 mg Q16W	Experimental	SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W) Receives: Drug: SLN360
SLN360 300 mg Q24W	Experimental	SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W) Receives: Drug: SLN360
SLN360 450 mg Q24W	Experimental	SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W) Receives: Drug: SLN360
Placebo Q16W	Placebo comparator	Placebo administered subcutaneously at Weeks 0, 16 and 32 (Q16W) Receives: Drug: Placebo
Placebo Q24W	Placebo comparator	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) Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 36
Clinical trial results (relative to Day 1 pre-dose) was calculated for each participant by estimating the sum of the area under the curve with the linear trapezoidal method for all scheduled assessments from Week 4 to Week 36, inclusive, divided by the total time interval between the Week 4 and Week 36 assessments. Analysis of variance was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure. Time-averaged percent change in lipoprotein(a) to Week 36 was the dependent variable, and treatment group was included as the predictor variable. The least squares means, standard errors, and 2-sided 95% confidence intervals for each treatment group and for the pairwise comparisons between the SLN360 and placebo groups were estimated.
Measured: Week 36

Secondary outcomes (8)

Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 48
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Measured: Week 48
Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 60
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Measured: Week 60
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 36
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Measured: Week 36
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 48
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Measured: Week 48
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 60
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Measured: Week 60
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 36
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Measured: Week 36
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 48
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Measured: Week 48
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 60
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Measured: Week 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 20221 Jul 2024

First posted13 Sep 2022
Study start13 Dec 2022
Primary completion11 Jan 2024
Study completion1 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05537571
Sponsor's protocol ID: SLN360-002
Status last verified: Jun 2025
First submitted: 6 Sep 2022
Last updated: 1 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 39556769
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.
PubMed 40699211
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.
PubMed 39329200
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.
PubMed 38682459

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study to Investigate Efficacy, Safety and Tolerability of SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events
ClinicalTrials.gov ID: NCT05537571
Acronym / sponsor ID: SLN360-002
Conditions: Cardiovascular Diseases, Atherosclerosis, Lipoprotein(a)
Keywords: Cardiovascular Diseases, Atherosclerosis, Lipoprotein(a)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Silence Therapeutics plcIndustry (pharma, biotech, devices)
Study start: 13 Dec 2022 (actual)
Primary completion: 11 Jan 2024 (actual)
Study completion: 1 Jul 2024 (actual)
First posted: 13 Sep 2022 (actual)
Results: Posted 1 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
SLN360 300 mg Q16W	Experimental	Drug: SLN360SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
SLN360 300 mg Q24W	Experimental	Drug: SLN360SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360 450 mg Q24W	Experimental	Drug: SLN360SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
Placebo Q16W	Placebo comparator	Drug: PlaceboPlacebo administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
Placebo Q24W	Placebo comparator	Drug: PlaceboPlacebo 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)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Lipoprotein(a) at screening equal to or greater than 125 nmol/L
At high risk of ASCVD events
A body mass index at screening in the range of 18.0 to 32.0 kg/m², inclusive

Key exclusion criteria (7 listed)

Renal dysfunction with estimated glomerular filtration rate less than 30 mL/min/1.73 m² at screening
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SLN360Also: ZerlasiranSLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)	Drug	SLN360 300 mg Q16W, SLN360 300 mg Q24W, SLN360 450 mg Q24W
PlaceboSodium chloride, solution for injection	Drug	Placebo Q16W, Placebo Q24W

Primary outcome

Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 36
Time frame: Week 36
Clinical trial results (relative to Day 1 pre-dose) was calculated for each participant by estimating the sum of the area under the curve with the linear trapezoidal method for all scheduled assessments from Week 4 to Week 36, inclusive, divided by the total time interval between the Week 4 and Week 36 assessments. Analysis of variance was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure. Time-averaged percent change in lipoprotein(a) to Week 36 was the dependent variable, and treatment group was included as the predictor variable. The least squares means, standard errors, and 2-sided 95% confidence intervals for each treatment group and for the pairwise comparisons between the SLN360 and placebo groups were estimated.

8 secondary outcomes

Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 48
Time frame: Week 48
Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 60
Time frame: Week 60
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 36
Time frame: Week 36
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 48
Time frame: Week 48
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 60
Time frame: Week 60
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 36
Time frame: Week 36
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 48
Time frame: Week 48
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 60
Time frame: Week 60

Results and safety

Results posted to the registry on 1 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SLN360 300 mg Q16W	44	39
SLN360 300 mg Q24W	44	43
SLN360 450 mg Q24W	45	44
Placebo Q16W	23	23
Placebo Q24W	24	23

Primary outcome: Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 36

Time frame: Week 36. Least squares mean (Standard Error). Unit: Percentage

Measure	SLN360 300 mg Q16W n = 42	SLN360 300 mg Q24W n = 44	SLN360 450 mg Q24W n = 45	Pooled Placebo n = 47
Value	-80.5 (1.99)	-79.1 (1.94)	-83.3 (1.92)	2.3 (1.88)

SLN360 300 mg Q16W vs Pooled Placebo: Mean Difference (Final Values): -82.8 (95% CI -88.19 to -77.39), p <0.0001, ANOVA
SLN360 300 mg Q24W vs Pooled Placebo: Mean Difference (Final Values): -81.3 (95% CI -86.68 to -76.0), p <0.0001, ANOVA
SLN360 450 mg Q24W vs Pooled Placebo: Mean Difference (Final Values): -85.6 (95% CI -90.88 to -80.26), p <0.0001, ANOVA

Population analysed: The pharmacodynamic population included all participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SLN360 300 mg Q16W	6 of 42 (14.3%)	42 of 42 (100%)	0 of 42
SLN360 300 mg Q24W	2 of 44 (4.5%)	43 of 44 (97.7%)	0 of 44
SLN360 450 mg Q24W	5 of 45 (11.1%)	42 of 45 (93.3%)	0 of 45
Placebo Q16W	1 of 23 (4.3%)	18 of 23 (78.3%)	0 of 23
Placebo Q24W	3 of 24 (12.5%)	22 of 24 (91.7%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 39556769Nissen 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.
Derived from this study: PubMed 40699211Nicholls 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.
Derived from this study: PubMed 39329200Nicholls 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.
Derived from this study: PubMed 38682459Dimitriadis 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.
PubMed PublicationLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

29 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SLN360 in people with Cardiovascular Diseases and Atherosclerosis, run by Silence Therapeutics plc at 29 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in South Africa, Netherlands, United Kingdom, Czechia, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 36 (time frame: Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05537571, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.