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Also known as Lepodisiran Sodium, LY3819469
Lepodisiran · 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...
Top 10 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 7 | PHASE3 | Ziltivekimab, Zenagamtide |
| Eli Lilly and Company | LLY | 6 | PHASE3 | Lepodisiran, Retatrutide, Muvalaplin, Orforglipron, Clazakizumab |
| Novartis AG Sponsored ADR | NVS | 8 | PHASE3 | Inclisiran, Pelacarsen |
| Amgen Inc. | AMGN | 4 | PHASE3 | Olpasiran, Maridebart cafraglutide |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Enlicitide |
| NewAmsterdam Pharma Company N.V. | NAMS | 2 | PHASE3 | Obicetrapib |
| United Therapeutics Corporation | UTHR | 1 | PHASE3 | Ralinepag |
| Roivant Sciences Ltd. | ROIV | 3 | PHASE3 | Mosliciguat |
| Genentech, Inc. | RHHBY | 1 | PHASE2 | Selnoflast |
| Verve Therapeutics, Inc. | VERV | 2 | PHASE2 | VERVE-102 |
Lepodisiran is an investigational RNA therapy being studied in adults with elevated lipoprotein(a) who have atherosclerotic cardiovascular disease or are at high risk of cardiovascular events. It is designed to lower Lp(a) levels and reduce the risk of major adverse cardiovascular events such as heart attack and stroke.
Lepodisiran is a small interfering RNA (siRNA) therapy. It targets the production of lipoprotein(a) by interfering with RNA to reduce the synthesis of apolipoprotein(a), a key component of Lp(a) particles. This mechanism aims to lower circulating Lp(a) levels, which are a known risk factor for cardiovascular disease.
Lepodisiran is being developed by Eli Lilly and Company (ticker: LLY). The company is conducting Phase 3 clinical trials to evaluate its safety and efficacy in reducing cardiovascular events in patients with elevated Lp(a).
Lepodisiran is in Phase 3 clinical development. It is not yet approved by the FDA or any regulatory agency. The ongoing Phase 3 program includes a large cardiovascular outcomes trial and a separate trial assessing plaque reduction in coronary arteries.
Lepodisiran is being evaluated in two Phase 3 trials: NCT06292013, known as ACCLAIM-Lp(a), which is assessing the reduction of major adverse cardiovascular events in 17,300 adults with elevated Lp(a) and ASCVD, and NCT07613294, which is studying whether lepodisiran can reduce coronary artery plaque in adults with elevated Lp(a) who have had heart events or are at high risk.
Yes, lepodisiran sodium is the salt form of lepodisiran and is often used interchangeably. Both names refer to the same investigational siRNA therapy developed by Eli Lilly and Company for lowering lipoprotein(a) and reducing cardiovascular risk.