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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05537571
• Other study ID #: SLN360-002
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 3, 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Silence Therapeutics plc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: June 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases

Intervention

Drug:
• SLN360
SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
• Placebo
Sodium chloride, solution for injection

Locations

Country	Name	City	State
Australia	No Longer Recruiting	Perth
Czechia	No Longer Recruiting	Prague
Denmark	No Longer Recruiting	Hellerup
Netherlands	No Longer Recruiting	Amsterdam
Slovakia	No Longer Recruiting	Bardejov
South Africa	No Longer Recruiting	Cape Town
United Kingdom	No Longer Recruiting	London

Sponsors (1)

Lead Sponsor	Collaborator
Silence Therapeutics plc

Countries where clinical trial is conducted

Australia,  Czechia,  Denmark,  Netherlands,  Slovakia,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time averaged change in Lp(a) from Baseline		Week 36
Secondary	Change (time-averaged and by visit) in Lp(a) from Baseline		Week 48
Secondary	Change (time-averaged and by visit) in Lp(a) from Baseline		Week 60
Secondary	Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline		Week 36
Secondary	Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline		Week 48
Secondary	Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline		Week 60