Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LY3473329
Muvalaplin · 3 trials · 4 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.
Least Squares Mean (LS Mean) was calculated using a Mixed Model for Repeated Measures (MMRM): Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment\*Time.
LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment\*Time.
PK: AUC0-∞ of LY3473329
PK: AUC0-tlast of LY3473329
PK: Cmax of LY3473329
| Arm | Type | Description |
|---|---|---|
| Muvalaplin | EXPERIMENTAL | Participants will receive muvalaplin orally. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo orally. |
| 10 mg LY3473329 | EXPERIMENTAL | Participants received 10 milligrams (mg) of LY3473329 administered orally once daily (QD) over a 12-week treatment period. |
| 60 mg LY3473329 | EXPERIMENTAL | Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period. |
| 240 mg LY3473329 | EXPERIMENTAL | Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period. |
| LY3473329 (Control) | EXPERIMENTAL | LY3473329 administered orally to participants with normal renal function |
| LY3473329 (Mild Renal Impairment) | EXPERIMENTAL | LY3473329 administered orally to participants with mild renal impairment |
| LY3473329 (Moderate Renal Impairment) | EXPERIMENTAL | LY3473329 administered orally to participants with moderate renal impairment |
| LY3473329 (Severe Renal Impairment) | EXPERIMENTAL | LY3473329 administered orally to participants with severe renal impairment |
| LY3473329 (End-Stage Renal Disease) | EXPERIMENTAL | LY3473329 administered orally to participants with end-stage renal disease |
| Name | Type | Description |
|---|---|---|
| Muvalaplin | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| LY3473329 | DRUG | Administered orally |
Inclusion Criteria: * Have Lp(a) ≥175 nanomoles per liter (nmol/L) * Meet one of the following criteria: * Have had a prior atherosclerotic cardiovascular disease (ASCVD) event (such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body) within 10 ye...
Muvalaplin is an investigational small molecule being developed for elevated lipoprotein(a), or Lp(a), a cardiovascular risk factor. It is being studied in adults with elevated Lp(a) and atherosclerotic cardiovascular disease (ASCVD) to assess its impact on major cardiovascular events.
Muvalaplin targets LPA, the gene that encodes apolipoprotein(a), a component of lipoprotein(a). By targeting LPA, the drug is designed to lower elevated Lp(a) levels, which are associated with increased cardiovascular risk.
Muvalaplin is being developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker symbol LLY.
Muvalaplin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is currently recruiting participants.
Muvalaplin is being evaluated in a Phase 3 trial with the identifier NCT07157774. This randomized, double-blind, placebo-controlled study is assessing the impact of Muvalaplin on major cardiovascular events in adults with elevated Lp(a) and atherosclerotic cardiovascular disease. The trial plans to enroll approximately 10,450 participants across multiple countries.
Muvalaplin is the sole name provided for this investigational drug. No alternative names or brand names have been associated with it in the available information.