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CompletedNCT05537571Updated Jul 1, 2025Results posted

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

A Phase 2 interventional study of SLN360 and Placebo in Cardiovascular Diseases, Atherosclerosis and Lipoprotein(a), sponsored by Silence Therapeutics plc. Completed at 29 sites in 7 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-01.

Sponsored by Silence Therapeutics plc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Cardiovascular Diseases
  • Atherosclerosis
  • Lipoprotein(a)

Keywords

  • Cardiovascular Diseases
  • Atherosclerosis
  • Lipoprotein(a)
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's enrollment of 180 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Silence Therapeutics plc is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
180 participants (actual)

Study arms

  • Experimental
    SLN360 300 mg Q16W

    SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)

    Drug: SLN360

  • Experimental
    SLN360 300 mg Q24W

    SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)

    Drug: SLN360

  • Experimental
    SLN360 450 mg Q24W

    SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)

    Drug: SLN360

  • Placebo comparator
    Placebo Q16W

    Placebo administered subcutaneously at Weeks 0, 16 and 32 (Q16W)

    Drug: Placebo

  • 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

Interventions

  • DrugSLN360

    SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)

    Also known as: Zerlasiran

  • DrugPlacebo

    Sodium chloride, solution for injection

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 36

Secondary outcomes

  1. 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.

    Time frame: Week 48

  2. 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.

    Time frame: Week 60

  3. 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.

    Time frame: Week 36

  4. 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.

    Time frame: Week 48

  5. 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.

    Time frame: Week 60

  6. 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.

    Time frame: Week 36

  7. 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.

    Time frame: Week 48

  8. 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.

    Time frame: Week 60

07

Results

Posted Jul 1, 2025

Participant flow

Participants were screened from 05 December 2022, first randomised participant signed informed consent on 13 December 2022 and last participant was randomised 27 April 2023.

Participant flow — Overall Study
MilestoneSLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPlacebo Q16WPlacebo Q24W
Started4444452324
Completed3943442323
Not completed51101
Withdrew: Withdrawal by subject11000
Withdrew: Adverse event20000
Withdrew: Hepatitis a screening result20000
Withdrew: Lost to follow-up00101

Outcome measures

PrimaryTime-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.

Time frame:
Week 36
Reported as:
Least squares mean · Percentage
Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 36
PercentageSLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPooled Placebo
Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 36-80.5 ± 1.99-79.1 ± 1.94-83.3 ± 1.922.3 ± 1.88
Statistical analysis
  • SLN360 300 mg Q16W vs Pooled Placebo · ANOVA · p = <0.0001 · Mean difference (final values): -82.8 · 95% CI -88.19 to -77.39
  • SLN360 300 mg Q24W vs Pooled Placebo · ANOVA · p = <0.0001 · Mean difference (final values): -81.3 · 95% CI -86.68 to -76.0
  • SLN360 450 mg Q24W vs Pooled Placebo · ANOVA · p = <0.0001 · Mean difference (final values): -85.6 · 95% CI -90.88 to -80.26
SecondaryTime-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.

Time frame:
Week 48
Reported as:
Least squares mean · Percentage
Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 48
PercentageSLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPooled Placebo
Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 48-81.6 ± 2.05-77.2 ± 2.00-81.5 ± 1.981.5 ± 1.94
Statistical analysis
  • SLN360 300 mg Q16W vs Pooled Placebo · ANOVA · p = <0.0001 · Mean difference (final values): -83.1 · 95% CI -88.7 to -77.57
  • SLN360 300 mg Q24W vs Pooled Placebo · ANOVA · p = <0.0001 · Mean difference (final values): -78.7 · 95% CI -84.18 to -73.17
  • SLN360 450 mg Q24W vs Pooled Placebo · ANOVA · p = <0.0001 · Mean difference (final values): -83.0 · 95% CI -88.43 to -77.49
SecondaryTime-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.

Time frame:
Week 60
Reported as:
Least squares mean · Percentage
Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 60
PercentageSLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPooled Placebo
Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 60-78.0 ± 2.24-70.7 ± 2.19-76.0 ± 2.161.1 ± 2.11
Statistical analysis
  • SLN360 300 mg Q16W vs Pooled Placebo · ANOVA · p = <0.0001 · Mean difference (final values): -79.2 · 95% CI -85.25 to -73.1
  • SLN360 300 mg Q24W vs Pooled Placebo · ANOVA · p = <0.0001 · Mean difference (final values): -71.8 · 95% CI -77.81 to -65.8
  • SLN360 450 mg Q24W vs Pooled Placebo · ANOVA · p = <0.0001 · Mean difference (final values): -77.1 · 95% CI -83.09 to -71.15
SecondaryTime-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.

Time frame:
Week 36
Reported as:
Least squares mean · Percentage
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 36
PercentageSLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPooled Placebo
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 36-16.9 ± 1.93-13.5 ± 1.88-18.6 ± 1.86-3.6 ± 1.82
Statistical analysis
  • SLN360 300 mg Q16W vs Pooled Placebo · ANOVA · p = <0.0001 · Mean difference (final values): -13.3 · 95% CI -18.55 to -8.09
  • SLN360 300 mg Q24W vs Pooled Placebo · ANOVA · p = =0.0002 · Mean difference (final values): -9.9 · 95% CI -15.02 to -4.68
  • SLN360 450 mg Q24W vs Pooled Placebo · ANOVA · p = <0.0001 · Mean difference (final values): -15.0 · 95% CI -20.1 to -9.82
SecondaryTime-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.

Time frame:
Week 48
Reported as:
Least squares mean · Percentage
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 48
PercentageSLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPooled Placebo
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 48-16.4 ± 1.94-12.6 ± 1.90-18.0 ± 1.88-4.0 ± 1.83
Statistical analysis
  • SLN360 300 mg Q16W vs Pooled Placebo · ANOVA · p = <0.0001 · Mean difference (final values): -12.3 · 95% CI -17.62 to -7.08
  • SLN360 300 mg Q24W vs Pooled Placebo · ANOVA · p = =0.0013 · Mean difference (final values): -8.6 · 95% CI -13.85 to -3.44
  • SLN360 450 mg Q24W vs Pooled Placebo · ANOVA · p = <0.0001 · Mean difference (final values): -14.0 · 95% CI -19.2 to -8.84
SecondaryTime-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.

Time frame:
Week 60
Reported as:
Least squares mean · Percentage
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 60
PercentageSLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPooled Placebo
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 60-15.0 ± 2.04-10.9 ± 1.99-16.4 ± 1.97-3.8 ± 1.93
Statistical analysis
  • SLN360 300 mg Q16W vs Pooled Placebo · ANOVA · p = <0.0001 · Mean difference (final values): -11.3 · 95% CI -16.81 to -5.73
  • SLN360 300 mg Q24W vs Pooled Placebo · ANOVA · p = =0.0106 · Mean difference (final values): -7.2 · 95% CI -12.64 to -1.69
  • SLN360 450 mg Q24W vs Pooled Placebo · ANOVA · p = <0.0001 · Mean difference (final values): -12.6 · 95% CI -18.04 to -7.15
SecondaryTime-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.

Time frame:
Week 36
Reported as:
Least squares mean · Percentage
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 36
PercentageSLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPooled Placebo
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 36-22.3 ± 8.16-20.1 ± 7.98-15.5 ± 7.899.6 ± 7.72
Statistical analysis
  • SLN360 300 mg Q16W vs Pooled Placebo · ANOVA · p = =0.0051 · Mean difference (final values): -31.9 · 95% CI -54.07 to -9.72
  • SLN360 300 mg Q24W vs Pooled Placebo · ANOVA · p = =0.0081 · Mean difference (final values): -29.7 · 95% CI -51.62 to -7.81
  • SLN360 450 mg Q24W vs Pooled Placebo · ANOVA · p = =0.0241 · Mean difference (final values): -25.1 · 95% CI -46.89 to -3.33
SecondaryTime-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.

Time frame:
Week 48
Reported as:
Least squares mean · Percentage
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 48
PercentageSLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPooled Placebo
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 48-20.9 ± 7.01-18.5 ± 6.85-17.0 ± 6.788.9 ± 6.63
Statistical analysis
  • SLN360 300 mg Q16W vs Pooled Placebo · ANOVA · p = =0.0023 · Mean difference (final values): -29.8 · 95% CI -48.86 to -10.76
  • SLN360 300 mg Q24W vs Pooled Placebo · ANOVA · p = =0.0046 · Mean difference (final values): -27.4 · 95% CI -46.23 to -8.58
  • SLN360 450 mg Q24W vs Pooled Placebo · ANOVA · p = =0.0068 · Mean difference (final values): -26.0 · 95% CI -44.67 to -7.24
SecondaryTime-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.

Time frame:
Week 60
Reported as:
Least squares mean · Percentage
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 60
PercentageSLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPooled Placebo
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 60-19.3 ± 7.45-16.8 ± 7.28-14.7 ± 7.199.3 ± 7.04
Statistical analysis
  • SLN360 300 mg Q16W vs Pooled Placebo · ANOVA · p = =0.0057 · Mean difference (final values): -28.7 · 95% CI -48.91 to -8.46
  • SLN360 300 mg Q24W vs Pooled Placebo · Mean difference (final values): -26.1 · 95% CI -46.13 to -6.16
  • SLN360 450 mg Q24W vs Pooled Placebo · ANOVA · p = 0.0179 · Mean difference (final values): -24.1 · 95% CI -43.93 to -4.2

Adverse events

Collected over 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).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SLN360 300 mg Q16W0/42 (0%)6/42 (14.3%)42/42 (100%)
SLN360 300 mg Q24W0/44 (0%)2/44 (4.5%)43/44 (97.7%)
SLN360 450 mg Q24W0/45 (0%)5/45 (11.1%)42/45 (93.3%)
Placebo Q16W0/23 (0%)1/23 (4.3%)18/23 (78.3%)
Placebo Q24W0/24 (0%)3/24 (12.5%)22/24 (91.7%)
Most frequent serious events
Showing 10 of 18
Most frequent serious events
EventSLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPlacebo Q16WPlacebo Q24W
Angina pectorisCardiac disorders0/420/440/451/230/24
Non-cardiac chest painGeneral disorders0/420/440/450/231/24
ErysipelasInfections and infestations0/420/440/450/231/24
Urinary tract infectionInfections and infestations0/420/440/450/231/24
Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/420/440/450/230/24
HypertensionVascular disorders1/420/440/450/230/24
Abdominal painGastrointestinal disorders1/420/440/450/230/24
DyspnoeaRespiratory, thoracic and mediastinal disorders1/420/440/450/230/24
OsteoarthritisMusculoskeletal and connective tissue disorders1/420/440/450/230/24
PolymyositisMusculoskeletal and connective tissue disorders1/420/440/450/230/24
Most frequent other events
Showing 10 of 25
Most frequent other events
EventSLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPlacebo Q16WPlacebo Q24W
Injection site reactionGeneral disorders35/4236/4437/452/232/24
COVID-19Infections and infestations2/426/444/453/234/24
Upper respiratory tract infectionInfections and infestations6/427/445/451/233/24
Influenza-like illnessGeneral disorders2/421/447/450/231/24
MyalgiaMusculoskeletal and connective tissue disorders1/421/447/451/231/24
MalaiseGeneral disorders6/420/444/450/231/24
NasopharyngitisInfections and infestations3/426/446/452/230/24
HeadacheNervous system disorders5/423/446/451/231/24
Urinary tract infectionInfections and infestations5/421/443/453/230/24
Angina pectorisCardiac disorders1/421/442/452/233/24

Baseline characteristics

The baseline data are based on the set of unique participants who were randomised and treated. This excludes 2 participant numbers that enrolled but were not treated, due to hepatitis A screening results, but were later rescreened and re-randomised / treated.

Age, Categorical
Age, Categorical(Participants)SLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPlacebo Q16WPlacebo Q24WTotal
<=18 years000000
Between 18 and 65 years192322121591
>=65 years23212311987
Age, Continuous
Age, Continuous(years)SLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPlacebo Q16WPlacebo Q24WTotal
Mean63.1 ± 9.8164.5 ± 8.6763.8 ± 10.2365.0 ± 8.7962.1 ± 9.4363.7 ± 9.41
Sex: Female, Male
Sex: Female, Male(Participants)SLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPlacebo Q16WPlacebo Q24WTotal
Female1113115646
Male3131341818132
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPlacebo Q16WPlacebo Q24WTotal
Hispanic or Latino000000
Not Hispanic or Latino4244452324178
Unknown or Not Reported000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPlacebo Q16WPlacebo Q24WTotal
American Indian or Alaska Native000000
Asian124018
Native Hawaiian or Other Pacific Islander000000
Black or African American102003
White3836362122153
More than one race2532113
Unknown or Not Reported010001
Region of Enrollment
Region of Enrollment(participants)SLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPlacebo Q16WPlacebo Q24WTotal
Netherlands1315168860
Czechia2123311
Denmark7933325
United Kingdom9695332
South Africa6893329
Slovakia203005
Australia3531416
Time from the initial date of elevated Lipoprotein(a) to randomisation date
Time from the initial date of elevated Lipoprotein(a) to randomisation date(months)SLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPlacebo Q16WPlacebo Q24WTotal
Median6.10 (1.30 to 12.10)5.45 (1.05 to 17.95)3.70 (1.30 to 11.50)3.60 (0.80 to 15.80)5.35 (1.20 to 28.70)4.45 (1.20 to 14.20)
Weight
Weight(kilograms)SLN360 300 mg Q16WSLN360 300 mg Q24WSLN360 450 mg Q24WPlacebo Q16WPlacebo Q24WTotal
Median84.15 (78.00 to 94.80)82.60 (73.65 to 95.70)80.20 (66.30 to 85.30)81.00 (66.20 to 91.20)84.10 (76.15 to 89.05)82.85 (72.20 to 91.10)

2 further baseline measures are reported on the registry.

08

Study locations

29 sites
  • 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
09

References and documents

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 ↗

Study documents

  • Study protocol · Aug 9, 2022
  • Statistical analysis plan · Feb 14, 2024

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05537571
Lead sponsor
Silence Therapeutics plc
Responsible party
Sponsor
First posted
Sep 13, 2022
Start date
Dec 13, 2022
Primary completion
Jan 11, 2024
Completion
Jul 1, 2024
Results posted
Jul 1, 2025
Last update
Jul 1, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cardiovascular Diseases→

Other studies from this sponsor

Silence Therapeutics plc

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