Phase 2
N=180
Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events
Cardiovascular Diseases · Atherosclerosis · Lipoprotein(a)
Bottom Line
View on ClinicalTrials.gov: NCT05537571 ↗Enrolled (actual)
180
Serious AEs
9.6%
Results posted
Jul 2025
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SLN360 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Silence Therapeutics plc
- Primary completion
- Jan 2024
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 |
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
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
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.