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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Cardiovascular Diseases, Atherosclerosis, Lipoprotein(a)

Intervention / Treatment
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* Drug: SLN360
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLN360 Dose 1<br>SLN360 for subcutaneous injection | Drug: SLN360<br>* SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)<br>|
| Experimental: SLN360 Dose 2<br>SLN360 for subcutaneous injection | Drug: SLN360<br>* SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)<br>|
| Experimental: SLN360 Dose 3<br>SLN360 for subcutaneous injection | Drug: SLN360<br>* SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)<br>|
| Placebo Comparator: Placebo Dose 1<br>Sodium chloride for subcutaneous injection | Drug: Placebo<br>* Sodium chloride, solution for injection<br>|
| Placebo Comparator: Placebo Dose 2 and 3<br>Sodium chloride for subcutaneous injection | Drug: Placebo<br>* Sodium chloride, solution for injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time averaged change in Lp(a) from Baseline |  | Week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (time-averaged and by visit) in Lp(a) from Baseline |  | Week 48 | 
| Change (time-averaged and by visit) in Lp(a) from Baseline |  | 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 |  | 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 |  | 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 |  | Week 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Cardiovascular Diseases, Lipoprotein(a)