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Also known as Lepodisiran Sodium, Lepodisiran
LY3819469 · 3 trials · 6 indications
Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent coronary revascularization.
LPa levels were assessed using Immuno turbidimetric method. Percent change is calculated as: Percent Change=\[(Lp(a) at Time Point-Lp(a) at Baseline)/Lp(a) at Baseline\]×100 Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with log(Lp(a)) - log(Baseline) = log(Baseline) + Treatment + Time + Treatment\*Time (Type III sum of squares) as post-baseline measures. Result presented is after back-transformation. Variance-Covariance structure = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.
| Arm | Type | Description |
|---|---|---|
| Lepodisiran | EXPERIMENTAL | Participants will receive lepodisiran subcutaneously (SC) |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo SC |
| Lepodisiran Sodium | EXPERIMENTAL | Lepodisiran sodium administered subcutaneously (SC). |
| 16 mg LY3819469 | EXPERIMENTAL | Participants received 16 milligrams (mg) of LY3819469 on day 1 and day 180, administered as a subcutaneous (SC) injection. |
| 96 mg LY3819469 | EXPERIMENTAL | Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection. |
| 400 mg LY3819469 | EXPERIMENTAL | Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection. |
| 400 mg LY3819469 + Placebo | EXPERIMENTAL | Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection. |
| Name | Type | Description |
|---|---|---|
| Lepodisiran | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Lepodisiran Sodium | DRUG | Administered SC |
| LY3819469 | DRUG | Administered SC |
Inclusion Criteria: * Have an Lp(a) ≥175 nmol/L * Have established cardiovascular (CV) disease or are at risk for a first CV event * Have angiographic evidence of coronary artery disease on screening CCTA * If taking lipid-lowering medications, inclusive of statins or prescription strength niacin a...
LY3819469 is an investigational RNA therapy being developed by Eli Lilly and Company for lipoprotein disorders. It is designed to address elevated lipoprotein(a), also called Lp(a), a lipid-related risk factor. The drug is in Phase 2 clinical development and has been studied in a completed trial of 320 participants.
LY3819469 is being developed for lipoprotein disorders, specifically for participants with elevated lipoprotein(a), or Lp(a). It is an investigational RNA therapy and has not been approved for any use. The completed Phase 2 trial enrolled adults aged 40 years and older with elevated Lp(a).
LY3819469 is being developed by Eli Lilly and Company, which trades under the ticker LLY. Lilly is the sponsor of the clinical program evaluating this RNA therapy in lipoprotein disorders, including the completed Phase 2 study in participants with elevated lipoprotein(a).
LY3819469 is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or any other regulatory agency for the treatment of lipoprotein disorders or elevated lipoprotein(a).
LY3819469 has been studied in the Phase 2 trial NCT05565742, titled A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)]. The trial was completed, randomized, double-blind, and placebo-controlled, enrolling 320 participants aged 40 years and older across the United States, Argentina, China, Denmark, Germany, Japan, Mexico, the Netherlands, Romania, and Spain.