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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05537571
Ethics application status
Date submitted
6/09/2022
Date registered
13/09/2022
Date last updated
31/07/2024

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

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

Experimental: VET guided tPA administration + standard care - Actilyse (tPA) will be administered as a 2-hour bolus then low dose infusion over 24 hours (safety and dose-finding stage) and 72 hours (randomised stage). Regular monitoring of the coagulation status and lysis time using VET will enable increases or decreases/cessation of the dose. Prophylactic low molecular weight heparin will continue throughout.

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

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
Completed
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
Actual
1/07/2024
Sample size
Target
Accrual to date
Final
180
Recruitment in Australia
Recruitment state(s)

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05537571