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

Phase 2

Completed

• Conditions: Lipoprotein(a); Atherosclerosis; Cardiovascular Diseases
• Interventions: Drug: Placebo; Drug: SLN360

• Registration Number: NCT05537571
• Lead Sponsor: Silence Therapeutics plc

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 available

Study Timeline

• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-13
• Study Start: 2023-01-03
• Primary Completion: 2024-01-11
• Status Verified: 2024-07
• Study Completion: 2024-07-01
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Dose 1	Placebo	Sodium chloride for subcutaneous injection
SLN360 Dose 1	SLN360	SLN360 for subcutaneous injection
Placebo Dose 2 and 3	Placebo	Sodium chloride for subcutaneous injection
SLN360 Dose 2	SLN360	SLN360 for subcutaneous injection
SLN360 Dose 3	SLN360	SLN360 for subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Time averaged change in Lp(a) from Baseline	Week 36

Secondary Outcome Measures

Name	Time	Method
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
Change (time-averaged and by visit) in Lp(a) from Baseline	Week 60

Trial Locations

Locations (1)

Completed; 🇬🇧 London, United Kingdom