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Zerlasiran (SLN360)

Phase 2

Cardiovascular Diseases | RNA-Based Therapies | Cardiovascular |Silence Therapeutics Plc American Depository Share|Trials Updated: Jul 1, 2025

Zerlasiran (SLN360) target and mechanism

Target class-Siran (Sirna)
ModalityRNA-Based Therapies

Also known as SLN360

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment250

FDA Designations

No designations recorded

Zerlasiran (SLN360) clinical trials

Zerlasiran (SLN360) · 2 trials · 6 indications

Phase 2 1Phase 1 1
NCT05537571Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease EventsCardiovascular Diseases
COMPLETED180 Analytics
PHASE2COMPLETED
Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events
Cardiovascular DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 36
Week 36

Clinical trial results (relative to Day 1 pre-dose) was calculated for each participant by estimating the sum of the area under the curve with the linear trapezoidal method for all scheduled assessments from Week 4 to Week 36, inclusive, divided by the total time interval between the Week 4 and Week 36 assessments. Analysis of variance was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure. Time-averaged percent change in lipoprotein(a) to Week 36 was the dependent variable, and treatment group was included as the predictor variable. The least squares means, standard errors, and 2-sided 95% confidence intervals for each treatment group and for the pairwise comparisons between the SLN360 and placebo groups were estimated.

Incidence of treatment-emergent adverse events
Day 150

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

Secondary Endpoints

Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 48
Week 48
Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 60
Week 60
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 36
Week 36
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SLN360 300 mg Q16WEXPERIMENTALSLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
SLN360 300 mg Q24WEXPERIMENTALSLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360 450 mg Q24WEXPERIMENTALSLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
Placebo Q16WPLACEBO_COMPARATORPlacebo administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
Placebo Q24WPLACEBO_COMPARATORPlacebo administered subcutaneously at Weeks 0 and 24 (Q24W). This group was stratified so that half of participants were dosed to match the SLN360 300 mg Q24W group and half were dosed to match the SLN360 450 mg Q24W group (with respect to injected volume)
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 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
PlaceboDRUGSodium chloride, solution for injection
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites29

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...

Countries:AustraliaCzechiaDenmarkNetherlandsSlovakiaSouth AfricaUnited KingdomUnited States
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Competitive Landscape -General Cardiovascular Diseases 66 trials (matched to "Cardiovascular Diseases")

Frequently asked questions about Zerlasiran (SLN360)

What is Zerlasiran (SLN360)?

Zerlasiran, also known as SLN360, is an investigational RNA therapy being developed for cardiovascular diseases and hyperlipidemias, specifically for people with elevated lipoprotein(a). It is a small interfering RNA (siRNA) therapy developed by Silence Therapeutics and has been studied in Phase 2 and Phase 1 clinical trials.

What is Zerlasiran used for?

Zerlasiran is being developed to treat cardiovascular diseases and hyperlipidemias in patients with elevated lipoprotein(a) who are at high risk of atherosclerotic cardiovascular disease events. Its clinical program has enrolled adults with elevated Lp(a), including a Phase 2 study in participants at high risk of atherosclerotic cardiovascular disease events.

How does Zerlasiran work?

Zerlasiran is a small interfering RNA (siRNA) therapy, a class of RNA therapy designed to act through RNA interference. It is being developed for elevated lipoprotein(a) and related cardiovascular conditions. Its clinical trials measured safety, tolerability, pharmacokinetics, and pharmacodynamic response in participants with elevated lipoprotein(a).

Who is developing Zerlasiran?

Zerlasiran (SLN360) is being developed by Silence Therapeutics Plc, whose American Depositary Shares trade on Nasdaq under the ticker SLN. The company has run both a Phase 1 and a Phase 2 study of the siRNA therapy in participants with elevated lipoprotein(a).

What phase is Zerlasiran in?

Zerlasiran is in Phase 2 development. Its Phase 2 trial, NCT05537571, has been completed, and an earlier Phase 1 study, NCT04606602, has also been completed. Zerlasiran is an investigational therapy and is not described as FDA approved.

What clinical trials is Zerlasiran in?

Zerlasiran has been studied in two completed trials. NCT05537571 was a Phase 2, randomized, double-blind, placebo-controlled study of 180 participants with elevated lipoprotein(a) at high risk of atherosclerotic cardiovascular disease events, run in Australia, Czechia, Denmark, the Netherlands, Slovakia, South Africa, and the United Kingdom. NCT04606602 was a Phase 1 study of 70 participants.

Is Zerlasiran the same as SLN360?

Yes, Zerlasiran and SLN360 are the same drug. SLN360 is the alternative name for zerlasiran, the siRNA therapy developed by Silence Therapeutics for cardiovascular diseases and hyperlipidemias, including elevated lipoprotein(a). Searches for either name refer to the same investigational asset.