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SLN360

Phase 1

Hyperlipidemias | Small molecule | Cardiovascular |Silence Therapeutics Plc American Depository Share|Last Updated: Aug 12, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

SLN360 · 1 trial · 3 indications

Phase 1 1
NCT04606602Study to Investigate Safety, Tolerability, PK and PD Response of SLN360 in Subjects With Elevated Lipoprotein(a)Hyperlipidemias
COMPLETED70 Analytics
PHASE1COMPLETED
Study to Investigate Safety, Tolerability, PK and PD Response of SLN360 in Subjects With Elevated Lipoprotein(a)
HyperlipidemiasUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events
Day 150

safety and tolerability will be reported separately following single-dose administration.

Secondary Endpoints

Pharmacokinetic: peak plasma concentration (Cmax)
Day 150 and Day 201
Pharmacokinetic: area under the plasma concentration (AUC)
Day 150 and Day 201
Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F)
Day 150 and Day 201
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
30 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
100 mgEXPERIMENTAL -
300 mgEXPERIMENTAL -
600 mgEXPERIMENTAL -
900 mgEXPERIMENTAL -
100 mg multi doseEXPERIMENTAL -
200 mg multi doseEXPERIMENTAL -
300 mg multi doseEXPERIMENTAL -
600 mg multi doseEXPERIMENTAL -
Placebo multi dosePLACEBO_COMPARATOR -

Interventions

NameTypeDescription
SLN360DRUGSLN360 for subcutaneous (s.c.) injection
PlaceboDRUGSodium chloride for subcutaneous (s.c.) injection
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion criteria: * Elevated plasma Lp(a) ≥ 150nmol/L. * All subjects must agree to adhere to appropriate contraception requirements. * Subjects must provide written informed consent and be able to comply with all study requirements. * Body mass index of ≥ 18 kg/m2 and ≤ 45 kg/m2. * For the MD pa...

Countries:United StatesAustraliaNetherlandsUnited Kingdom
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Frequently asked questions about SLN360

What is SLN360 used for?

SLN360 is an investigational drug being studied for the treatment of hyperlipidemias, specifically elevated lipoprotein(a) levels. It is being developed as a potential therapy for patients with dyslipidemias and elevated Lp(a), a condition associated with increased cardiovascular risk.

What does SLN360 target?

SLN360 is a small molecule designed to target elevated lipoprotein(a), a type of lipid in the blood. By addressing elevated Lp(a) levels, it aims to treat hyperlipidemias and dyslipidemias, potentially reducing cardiovascular risk associated with this condition.

Who makes SLN360?

SLN360 is being developed by Silence Therapeutics Plc, a biopharmaceutical company. The company's American Depository Shares are traded under the ticker symbol SLN on the NASDAQ stock exchange.

What phase is SLN360 in?

SLN360 is currently in Phase 1 clinical development. It has completed one Phase 1 trial, and the drug remains investigational, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical evaluation.

What clinical trials is SLN360 in?

SLN360 has been studied in a Phase 1 clinical trial with the identifier NCT04606602. This completed trial investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of SLN360 in subjects with elevated lipoprotein(a). The study enrolled 70 participants across the United States, Australia, Netherlands, and United Kingdom.

Is SLN360 the same as any other drug?

SLN360 is a unique investigational drug candidate developed by Silence Therapeutics. It is not known to be the same as any other approved or investigational medication, as it is specifically designed to target elevated lipoprotein(a) levels for the treatment of hyperlipidemias.