Clinical trial NCT05537571: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Diseases
Atherosclerosis
Lipoprotein(a)
Keywords: Cardiovascular Diseases
Atherosclerosis
Lipoprotein(a)
Lead sponsor: Silence Therapeutics plc
Sponsor class: INDUSTRY
First posted: 2022-09-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Time averaged change in Lp(a) from Baseline
timeFrame: Week 36
Secondary outcomes:
measure: Change (time-averaged and by visit) in Lp(a) from Baseline
timeFrame: Week 48
measure: Change (time-averaged and by visit) in Lp(a) from Baseline
timeFrame: Week 60
measure: Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline
timeFrame: Week 36
measure: Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline
timeFrame: Week 48
measure: Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline
timeFrame: Week 60
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Completed
city: Prague
country: Czechia
facility: Completed
city: Hellerup
country: Denmark
facility: Completed
city: Amsterdam
country: Netherlands
facility: Completed
city: Bardejov
country: Slovakia
facility: Completed
city: Cape Town
country: South Africa
facility: Completed
city: London
country: United Kingdom
facility: Completed
Study officials:
References: