Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3819469 · 4 trials · 3 indications
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.
PK: AUC\[0-tlast\] of LY3819469
PK: AUC\[0-∞\] of LY3819469
PK: Cmax of LY3819469
PK: AUC0-tlast of LY3819469
PK: AUC0-∞ of LY3819469
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| 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. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo on day 1 and day 180, administered as a SC injection. |
| LY3819469 (Reference) | EXPERIMENTAL | LY3819469 administered subcutaneously (SC). |
| LY3819469 (Test) | EXPERIMENTAL | LY3819469 administered SC. |
| LY3819469 (Control) | EXPERIMENTAL | LY3819469 administered subcutaneously (SC) to participants with normal renal function |
| LY3819469 (Severe Renal Impairment) | EXPERIMENTAL | LY3819469 administered SC to participants with severe renal impairment |
| LY3819469 (End-Stage Renal Disease) | EXPERIMENTAL | LY3819469 administered SC to participants with end-stage renal disease (ESRD) |
| 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 |
|---|---|---|
| LY3819469 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
Inclusion Criteria: * Participants must be at least 40 years old at the time of signing the informed consent. * Participants with Lp(a) ≥175 nmol/L at screening, measured at the central laboratory * Participants on the following medications according to local practice must be on a stable regimen fo...
LY3819469 is an investigational small molecule being studied for conditions including elevated lipoprotein(a), or Lp(a), a type of lipoprotein disorder, as well as in healthy participants and those with renal insufficiency. It is not approved and remains in clinical development.
LY3819469 is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker LLY. The company has sponsored clinical trials of the drug across multiple countries.
LY3819469 has completed Phase 1 and Phase 2 clinical trials. Studies have been conducted in healthy participants, in participants with elevated lipoprotein(a), and in those with impaired or normal renal function. The drug is investigational and not yet approved.
LY3819469 has been studied in several completed trials, including NCT04914546 in healthy participants, NCT05565742 in participants with elevated Lp(a), NCT05841277 in participants with impaired and normal renal function, and NCT05932446 comparing two formulations in healthy participants.
LY3819469 is the drug name used in clinical trial records for the investigational therapy developed by Eli Lilly. No alternative names have been reported in the available trial information.