Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events
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
Timeline
- Start
- 2022-12-13
- Primary completion
- 2024-01-11
- Completion
- 2024-07-01
Outcome
Met primary endpoint
registry analysis (superiority test); SLN360 300 mg Q16W vs Pooled Placebo; p <0.0001; Mean Difference (Final Values) -82.8 (95% CI -88.19 to -77.39); ANOVA NCT05537571 ↗
registry analysis (superiority test); SLN360 300 mg Q24W vs Pooled Placebo; p <0.0001; Mean Difference (Final Values) -81.3 (95% CI -86.68 to -76.0); ANOVA NCT05537571 ↗
registry analysis (superiority test); SLN360 450 mg Q24W vs Pooled Placebo; p <0.0001; Mean Difference (Final Values) -85.6 (95% CI -90.88 to -80.26); ANOVA NCT05537571 ↗
release “These data demonstrated a highly significant reduction from baseline in Lp(a) compared to placebo to 36 weeks (primary endpoint).” silence-therapeutics.com ↗
Publications
- Results Nissen SE, Wang Q, Nicholls SJ, Navar AM, Ray KK, Schwartz GG, Szarek M, Stroes ESG, Troquay R, Dorresteijn JAN, Fok H, Rider DA, Romano S, Wolski K, Rambaran C. Zerlasiran-A Small-Interfering RNA Targeting Lipoprotein(a): A Phase 2 Randomized Clinical Trial. JAMA. 2024 Dec 17;332(23):1992-2002. doi: 10.1001/jama.2024.21957.
- Nicholls SJ. Therapeutic lowering of lipoprotein(a): implications for improving outcomes in patients with peripheral arterial disease. Curr Opin Lipidol. 2025 Oct 1;36(5):232-237. doi: 10.1097/MOL.0000000000001002. Epub 2025 Jul 21.
- Nicholls SJ, Nelson AJ, Michael LF. Oral agents for lowering lipoprotein(a). Curr Opin Lipidol. 2024 Dec 1;35(6):275-280. doi: 10.1097/MOL.0000000000000953. Epub 2024 Sep 25.
- Dimitriadis K, Theofilis P, Iliakis P, Pyrpyris N, Dri E, Sakalidis A, Soulaidopoulos S, Tsioufis P, Fragkoulis C, Chrysohoou C, Tsiachris D, Tsioufis K. Management of dyslipidemia in coronary artery disease: the present and the future. Coron Artery Dis. 2024 Sep 1;35(6):516-524. doi: 10.1097/MCA.0000000000001375. Epub 2024 Apr 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | zerlasiran | Small interfering RNA (siRNA) | 300 mg | Subcutaneous |
| Subject | zerlasiran | Small interfering RNA (siRNA) | 450 mg | Subcutaneous |