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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05537571




Registration number
NCT05537571
Ethics application status
Date submitted
6/09/2022
Date registered
13/09/2022
Date last updated
13/02/2024

Titles & IDs
Public title
Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events
Scientific 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
Secondary ID [1] 0 0
SLN360-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 0 0
Atherosclerosis 0 0
Lipoprotein(a) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SLN360
Treatment: Drugs - Placebo

Experimental: SLN360 Dose 1 - SLN360 for subcutaneous injection

Experimental: SLN360 Dose 2 - SLN360 for subcutaneous injection

Experimental: SLN360 Dose 3 - SLN360 for subcutaneous injection

Placebo Comparator: Placebo Dose 1 - Sodium chloride for subcutaneous injection

Placebo Comparator: Placebo Dose 2 and 3 - Sodium chloride for subcutaneous injection


Treatment: Drugs: SLN360
SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)

Treatment: Drugs: Placebo
Sodium chloride, solution for injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time averaged change in Lp(a) from Baseline
Timepoint [1] 0 0
Week 36
Secondary outcome [1] 0 0
Change (time-averaged and by visit) in Lp(a) from Baseline
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Change (time-averaged and by visit) in Lp(a) from Baseline
Timepoint [2] 0 0
Week 60
Secondary outcome [3] 0 0
Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline
Timepoint [3] 0 0
Week 36
Secondary outcome [4] 0 0
Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline
Timepoint [4] 0 0
Week 48
Secondary outcome [5] 0 0
Change (time-averaged and by visit) in other lipids/lipoproteins, including low density lipoprotein cholesterol (LDL-C) and Apolipoprotein (B) (apoB) from Baseline
Timepoint [5] 0 0
Week 60

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
Accrual to date
Final
180
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
No Longer Recruiting - Perth
Recruitment postcode(s) [1] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Prague
Country [2] 0 0
Denmark
State/province [2] 0 0
Hellerup
Country [3] 0 0
Netherlands
State/province [3] 0 0
Amsterdam
Country [4] 0 0
Slovakia
State/province [4] 0 0
Bardejov
Country [5] 0 0
South Africa
State/province [5] 0 0
Cape Town
Country [6] 0 0
United Kingdom
State/province [6] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Silence Therapeutics plc
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT05537571
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05537571