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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 : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
Silence Therapeutics plc

Study Description
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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

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Atherosclerosis Lipoprotein(a) Drug: SLN360 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 3, 2023
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: SLN360 Dose 1
SLN360 for subcutaneous injection
 Drug: SLN360
SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
Experimental: SLN360 Dose 2
SLN360 for subcutaneous injection
 Drug: SLN360
SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
Experimental: SLN360 Dose 3
SLN360 for subcutaneous injection
 Drug: SLN360
SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
Placebo Comparator: Placebo Dose 1
Sodium chloride for subcutaneous injection
 Drug: Placebo
Sodium chloride, solution for injection
Placebo Comparator: Placebo Dose 2 and 3
Sodium chloride for subcutaneous injection
 Drug: Placebo
Sodium chloride, solution for injection


Outcome Measures
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Primary Outcome Measures :
  1. Time averaged change in Lp(a) from Baseline [ Time Frame: Week 36 ]

Secondary Outcome Measures :
  1. Change (time-averaged and by visit) in Lp(a) from Baseline [ Time Frame: Week 48 ]
  2. Change (time-averaged and by visit) in Lp(a) from Baseline [ Time Frame: Week 60 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05537571


Locations
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Australia
No Longer Recruiting
Perth, Australia
Czechia
No Longer Recruiting
Prague, Czechia
Denmark
No Longer Recruiting
Hellerup, Denmark
Netherlands
No Longer Recruiting
Amsterdam, Netherlands
Slovakia
No Longer Recruiting
Bardejov, Slovakia
South Africa
No Longer Recruiting
Cape Town, South Africa
United Kingdom
No Longer Recruiting
London, United Kingdom
Sponsors and Collaborators
Silence Therapeutics plc
More Information
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Responsible Party: Silence Therapeutics plc
ClinicalTrials.gov Identifier: NCT05537571    
Other Study ID Numbers: SLN360-002
First Posted: September 13, 2022    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023

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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
Keywords provided by Silence Therapeutics plc:
Cardiovascular Diseases
Atherosclerosis
Lipoprotein(a)
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases