A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)]
Summary
The main purpose of this study is to determine the efficacy and safety of LY3819469 in adults with elevated lipoprotein(a). The study will lasts about 20 months.
Timeline
- Start
- 2022-10-20
- Primary completion
- 2023-10-23
- Completion
- 2024-10-17
Outcome
Met primary endpoint
registry analysis (superiority test); 16 mg LY3819469 vs Placebo; p <0.001; LS Mean difference (Final Values) -40.8 (95% CI -55.8 to -20.6); Mixed Models Analysis NCT05565742 ↗
registry analysis (superiority test); 96 mg LY3819469 vs Placebo; p <0.001; LS Mean difference (Final Values) -75.2 (95% CI -80.4 to -68.5); Mixed Models Analysis NCT05565742 ↗
registry analysis (superiority test); 400 mg LY3819469 and 400 mg LY3819469 + Placebo (400 mg LY3819469 Pooled) vs Placebo; p <0.001; LS Mean difference (Final Values) -93.9 (95% CI -95.1 to -92.5); Mixed Models Analysis NCT05565742 ↗
release “In Phase 2 ALPACA results, lepodisiran significantly reduced levels of genetically inherited cardiovascular risk factor, with some patients sustaining reductions for nearly 1.5 years” lilly.com ↗
Publications
- Nissen SE, Ni W, Shen X, Wang Q, Navar AM, Nicholls SJ, Wolski K, Michael L, Haupt A, Krege JH; ALPACA Trial Investigators. Lepodisiran - A Long-Duration Small Interfering RNA Targeting Lipoprotein(a). N Engl J Med. 2025 May 1;392(17):1673-1683. doi: 10.1056/NEJMoa2415818. Epub 2025 Mar 30.
- Makhmudova U, Steinhagen-Thiessen E, Volpe M, Landmesser U. Advances in nucleic acid-targeted therapies for cardiovascular disease prevention. Cardiovasc Res. 2024 Sep 2;120(10):1107-1125. doi: 10.1093/cvr/cvae136.
- Karp A, Jacobs M, Barris B, Labkowsky A, Frishman WH. Lipoprotein(a): A Review of Risk Factors, Measurements, and Novel Treatment Modalities. Cardiol Rev. 2025 Jul-Aug 01;33(4):352-358. doi: 10.1097/CRD.0000000000000667. Epub 2024 Feb 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lepodisiran | Unknown | 16 mg | Subcutaneous |
| Subject | Lepodisiran | Unknown | 96 mg | Subcutaneous |
| Subject | Lepodisiran | Unknown | 400 mg | Subcutaneous |