Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events

Silence Therapeutics

Status and phase: Completed; Phase 2

Conditions: Cardiovascular Diseases; Lipoprotein(a); Atherosclerosis

Treatments: Drug: SLN360; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05537571

SLN360-002

Details and patient eligibility

About

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

Enrollment: 180 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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/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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 5 patient groups, including a placebo group

SLN360 300 mg Q16W

Experimental group

Description:

SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)

Treatment:

Drug: SLN360

SLN360 300 mg Q24W

Experimental group

Description:

SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)

Treatment:

Drug: SLN360

SLN360 450 mg Q24W

Experimental group

Description:

SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)

Treatment:

Drug: SLN360

Placebo Q16W

Placebo Comparator group

Description:

Placebo administered subcutaneously at Weeks 0, 16 and 32 (Q16W)

Treatment:

Drug: Placebo

Placebo Q24W

Placebo Comparator group

Description:

Placebo 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)

Treatment:

Drug: Placebo