Phase 2 Completed N=180 Randomized Double-blind Treatment

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

Cardiovascular Disease · Atherosclerosis · Lipoprotein(a)

Source: ClinicalTrials.gov NCT05537571 ↗

Enrolled (actual)

180

Serious AEs

9.6%

Results posted

Jul 2025

Primary outcomePrimary: Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 36 — -80.5; -79.1; -83.3; 2.3 Percentage — p=<0.0001

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 36	-80.5; -79.1; -83.3; 2.3	<0.0001 sig
SECONDARY Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 48	-81.6; -77.2; -81.5; 1.5	<0.0001 sig
SECONDARY Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 60	-78.0; -70.7; -76.0; 1.1	<0.0001 sig
SECONDARY Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 36	-16.9; -13.5; -18.6; -3.6	<0.0001 sig
SECONDARY Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 48	-16.4; -12.6; -18.0; -4.0	<0.0001 sig
SECONDARY Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 60	-15.0; -10.9; -16.4; -3.8	<0.0001 sig
SECONDARY Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 36	-22.3; -20.1; -15.5; 9.6	=0.0051 sig
SECONDARY Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 48	-20.9; -18.5; -17.0; 8.9	=0.0023 sig
SECONDARY Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 60	-19.3; -16.8; -14.7; 9.3	=0.0057 sig

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05537571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.