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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05537571
Recruitment Status : Active, not recruiting
First Posted : September 13, 2022
Last Update Posted : February 13, 2024
Sponsor:
Information provided by (Responsible Party):
Silence Therapeutics plc

Tracking Information
First Submitted Date  ICMJE September 6, 2022
First Posted Date  ICMJE September 13, 2022
Last Update Posted Date February 13, 2024
Actual Study Start Date  ICMJE January 3, 2023
Actual Primary Completion Date January 11, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2022)
Time averaged change in Lp(a) from Baseline [ Time Frame: Week 36 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2022)
  • Change (time-averaged and by visit) in Lp(a) from Baseline [ Time Frame: Week 48 ]
  • Change (time-averaged and by visit) in Lp(a) from Baseline [ Time Frame: Week 60 ]
  • Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline [ Time Frame: Week 36 ]
  • Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline [ Time Frame: Week 48 ]
  • Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline [ Time Frame: Week 60 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events
Official Title  ICMJE 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
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiovascular Diseases
  • Atherosclerosis
  • Lipoprotein(a)
Intervention  ICMJE
  • Drug: SLN360
    SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
  • Drug: Placebo
    Sodium chloride, solution for injection
Study Arms  ICMJE
  • Experimental: SLN360 Dose 1
    SLN360 for subcutaneous injection
    Intervention: Drug: SLN360
  • Experimental: SLN360 Dose 2
    SLN360 for subcutaneous injection
    Intervention: Drug: SLN360
  • Experimental: SLN360 Dose 3
    SLN360 for subcutaneous injection
    Intervention: Drug: SLN360
  • Placebo Comparator: Placebo Dose 1
    Sodium chloride for subcutaneous injection
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo Dose 2 and 3
    Sodium chloride for subcutaneous injection
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 12, 2024)
180
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2022)
160
Estimated Study Completion Date  ICMJE June 2024
Actual Primary Completion Date January 11, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Czechia,   Denmark,   Netherlands,   Slovakia,   South Africa,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05537571
Other Study ID Numbers  ICMJE SLN360-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Silence Therapeutics plc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Silence Therapeutics plc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Silence Therapeutics plc
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP