Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05565742 | A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)] | PHASE2 | COMPLETED | 320 | — | — | Oct 20, 2022 | Oct 17, 2024 | May 28, 2025 | 80 | United States, Argentina +8 |
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 |
|---|---|---|
| 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. |
| 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...