drugset / Trial / NCT04914546
A Study of LY3819469 in Healthy Participants
RandomizedSequentialDouble-blindBasic science
Summary
This is a 2-part study. In Part A, the main purpose is to evaluate the safety and tolerability of the study drug LY3819469 in healthy participants with high lipoprotein (a) \[Lp(a)\] levels. How the body processes the study drug and the effect of the study drug on blood Lp(a) levels will also be investigated. Part B will mainly evaluate the safety and tolerability of LY3819469 as well as how the body processes the study drug in Japanese participants. The study may last up to 53 and 29 weeks for each participant in Parts A and B, respectively.
Timeline
- Start
- 2021-06-14
- Primary completion
- 2022-11-09
- Completion
- 2022-11-09
Publications
- 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.
- Nissen SE, Linnebjerg H, Shen X, Wolski K, Ma X, Lim S, Michael LF, Ruotolo G, Gribble G, Navar AM, Nicholls SJ. Lepodisiran, an Extended-Duration Short Interfering RNA Targeting Lipoprotein(a): A Randomized Dose-Ascending Clinical Trial. JAMA. 2023 Dec 5;330(21):2075-2083. doi: 10.1001/jama.2023.21835.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lepodisiran | Unknown | 4 mg | Subcutaneous |
| Subject | Lepodisiran | Unknown | 12 mg | Subcutaneous |
| Subject | Lepodisiran | Unknown | 32 mg | Subcutaneous |
| Subject | Lepodisiran | Unknown | 96 mg | Subcutaneous |
| Subject | Lepodisiran | Unknown | 304 mg | Subcutaneous |
| Subject | Lepodisiran | Unknown | 608 mg | Subcutaneous |
Indications
No indication recorded.