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| ID | Type | Description | Link |
|---|---|---|---|
| J3L-MC-EZEA | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3819469 (Part A) | Experimental | Single ascending doses of LY3819469 administered subcutaneously (SC). |
|
| LY3819469 (Part B) | Experimental | Single doses of LY3819469 administered SC in Japanese Participants. |
|
| Placebo (Part A) | Placebo Comparator | Placebo administered SC. |
|
| Placebo (Part B) | Placebo Comparator | Placebo administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3819469 | Drug | Administered SC. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to Week 49 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3819469 | PK: AUC[0-∞] of LY3819469 | Predose through Day 15 |
| PK: Maximum Observed Drug Concentration (Cmax) of LY3819469 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical Los Angeles, Inc | Cypress | California | 90630 | United States | ||
| Clinical Pharmacology of Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38415744 | Derived | 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. | |
| 37952254 | Derived | 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. |
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| Placebo |
| Drug |
Administered SC. |
|
PK: Cmax of LY3819469
| Predose through Day 15 |
| Pharmacodynamics (PD): Change From Baseline in Fasting Lp(a) | PD: Change From Baseline in Fasting Lp(a) | Baseline up to Week 49 |
| Miami |
| Florida |
| 33014 |
| United States |
| Qps-Mra, Llc | Miami | Florida | 33143 | United States |
| Endeavor Clinical Trials | San Antonio | Texas | 78229 | United States |
| Lilly Centre for Clinical Pharmacology | Singapore | 138623 | Singapore |