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

• ClinicalTrials.gov Identifier: NCT05537571
• Recruitment Status: Active, not recruiting
• First Posted: September 13, 2022
• Last Update Posted: May 24, 2023
• Sponsor: Silence Therapeutics plc
• Information provided by (Responsible Party): Silence Therapeutics plc

Tracking Information

• First Submitted Date: September 6, 2022
• First Posted Date: September 13, 2022
• Last Update Posted Date: May 24, 2023
• Actual Study Start Date: January 3, 2023
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 12, 2022): Time averaged change in Lp(a) from Baseline [ Time Frame: Week 36 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Cardiovascular Diseases
• Atherosclerosis
• Lipoprotein(a)

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 12, 2022): 160
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2024
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Czechia, Denmark, Netherlands, Slovakia, South Africa, United Kingdom

Administrative Information

• NCT Number: NCT05537571
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Silence Therapeutics plc
• Original Responsible Party: Same as current
• Current Study Sponsor: Silence Therapeutics plc
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Silence Therapeutics plc
• Verification Date: May 2023