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Zerlasiran (SLN360)

Phase 1

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

Target and mechanism

Target class-Siran (Sirna)
ModalityRNA therapy

Also known as SLN360

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

Zerlasiran (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 Zerlasiran (SLN360)

What is Zerlasiran (SLN360) used for?

Zerlasiran is an investigational RNA therapy being developed for hyperlipidemias, including dyslipidemias and elevated lipoprotein(a). It is designed to reduce elevated Lp(a) levels in adults. It has not been approved for any indication and remains in clinical development.

How does Zerlasiran work?

Zerlasiran is a small interfering RNA (siRNA) therapy. It targets the production of lipoprotein(a) to lower elevated Lp(a) levels. By silencing specific RNA, it aims to reduce the synthesis of this lipoprotein. This mechanism is characteristic of the -siran class of RNA therapies.

Who is developing Zerlasiran?

Zerlasiran is being developed by Silence Therapeutics Plc, whose American Depositary Shares trade on the Nasdaq under the ticker SLN. The company is responsible for the clinical development of the drug.

What phase is Zerlasiran in?

Zerlasiran is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any regulatory agency. The Phase 1 trial has been completed.

What clinical trials is Zerlasiran in?

Zerlasiran has been studied in one completed Phase 1 trial, NCT04606602, titled "Study to Investigate Safety, Tolerability, PK and PD Response of SLN360 in Subjects With Elevated Lipoprotein(a)." It enrolled 70 participants across the United States, Australia, Netherlands, and United Kingdom.

Is Zerlasiran the same as SLN360?

Yes, Zerlasiran is also known as SLN360. SLN360 is the original code name for the same investigational siRNA therapy developed by Silence Therapeutics. Both names refer to the identical drug candidate.