Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]-LY3473329, Muvalaplin
LY3473329 · 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...
LY3473329 is an investigational small molecule developed by Eli Lilly and Company for lipoprotein disorders and renal insufficiency. It is a metabolic therapy being studied in adults with elevated lipoprotein(a) who are at high risk for cardiovascular events, and separately in people with impaired and normal renal function.
LY3473329 is being studied for lipoprotein disorder, specifically elevated lipoprotein(a) in adults at high risk for cardiovascular events, and for renal insufficiency. It is an investigational therapy and is not approved for any use. The Phase 2 study enrolled adults aged 40 years and older.
LY3473329 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical program evaluating the small molecule in lipoprotein disorder and renal insufficiency.
LY3473329 is in Phase 2 development. The Phase 2 trial in adults with elevated lipoprotein(a) at high risk for cardiovascular events has completed, and a Phase 1 study in participants with impaired and normal renal function has also completed. The drug remains investigational.
LY3473329 has been studied in two completed trials. NCT05563246 was a Phase 2 study in adults with elevated lipoprotein(a) at high risk for cardiovascular events, enrolling 233 participants across the United States, Australia, Brazil, China, Germany, Hungary, Japan and the Netherlands. NCT05778864 was a Phase 1 study in participants with impaired and normal renal function, enrolling 47 people in the United States.
Yes, [14C]-LY3473329 is an alternative designation for LY3473329. The bracketed carbon-14 label refers to a radiolabeled form used in study work, while LY3473329 is the compound itself, an investigational small molecule developed by Eli Lilly and Company for lipoprotein disorder and renal insufficiency.