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OpenTrials
Completed

NCT Number: NCT05537571

Evaluate 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

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Key information

Conditions

Cardiovascular Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Lipoprotein(a) Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Adelaide Hospital, Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SLN360

Drug

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

Other names: Zerlasiran

Placebo

Drug

Sodium chloride, solution for injection

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Silence Therapeutics plc

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 13, 2022
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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