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

June 27, 2025 updated by: Silence Therapeutics plc

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Adelaide, Australia
        • Royal Adelaide Hospital
      • Melbourne, Australia
        • Monash Health
      • Nedlands, Australia
        • Linear Clinical Research
  • Czechia
      • Brandýs Nad Labem, Czechia
        • Medicus Services sro
      • Náchod, Czechia
        • Edumed s.r.o., Kardiologicka, endokrinologicka, diabetologicka a interni ambulance Nachod
      • Pardubice, Czechia
        • Pratia Pardubice a.s.
      • Prague, Czechia
        • Endokrinologie Cerny Most s.r.o.
  • Denmark
      • Hellerup, Denmark
        • Gentofte Hospital
      • Herning, Denmark
        • Regionshospitalet Godstrup
      • Viborg, Denmark
        • Viborg Regional Hospital
  • Netherlands
      • Amsterdam, Netherlands
        • Onze Lieve Vrouwe Gasthuis
      • Amsterdam, Netherlands
        • Academic Medical Center - Department of Vascular Medicine
      • Roosendaal, Netherlands
        • Bravis Ziekenhuis - Bergen op Zoom
      • Utrecht, Netherlands
        • Universitair Medisch Centrum Utrecht
      • Venlo, Netherlands
        • VieCuri Medisch Centrum
  • Slovakia
      • Bardejov, Slovakia
        • Alian, s.r.o., Kardiologicka ambulancia
      • Lučenec, Slovakia
        • Kardiomed s.r.o.
  • South Africa
      • Bloemfontein, South Africa
        • Iatros International
      • Cape Town, 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
      • Paarl, South Africa
        • Paarl Research Centre
      • Somerset West, South Africa
        • Dr JM Engelbrecht Trial Site
      • Somerset West, South Africa
        • Helderberg Research Institute
  • United Kingdom
      • Brighton, United Kingdom
        • Royal Sussex County Hospital
      • London, United Kingdom
        • Chelsea and Westminster Hospital
      • London, United Kingdom
        • Panthera - London North
      • Rochdale, United Kingdom
        • Panthera - Manchester
      • Sheffield, United Kingdom
        • Panthera - Sheffield

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SLN360 300 mg Q16W
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
Drug: SLN360
SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
Other Names:
  • Zerlasiran
Experimental: SLN360 300 mg Q24W
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
Drug: SLN360
SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
Other Names:
  • Zerlasiran
Experimental: SLN360 450 mg Q24W
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
Drug: SLN360
SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
Other Names:
  • Zerlasiran
Placebo Comparator: Placebo Q16W
Placebo administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
Drug: Placebo
Sodium chloride, solution for injection
Placebo Comparator: 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)
Drug: Placebo
Sodium chloride, solution for injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Week 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 48
Time Frame: Week 48
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Week 48
Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 60
Time Frame: Week 60
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Week 60
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 36
Time Frame: Week 36
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Week 36
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 48
Time Frame: Week 48
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Week 48
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 60
Time Frame: Week 60
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Week 60
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 36
Time Frame: Week 36
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Week 36
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 48
Time Frame: Week 48
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Week 48
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 60
Time Frame: Week 60
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Week 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Silence Therapeutics plc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SLN360-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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