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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03626662 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a) | PHASE1 | COMPLETED | 79 | — | — | Jul 30, 2018 | Apr 18, 2023 | Jan 28, 2026 | 9 | United States, Australia |
An adverse event was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was defined as any event with onset after the administration of the first dose of investigational product and up to and including the end of treatment date, or end of trial for participants who discontinued the trial during the treatment period. Clinically significant changes in vital signs, electrocardiograms (ECGs), and safety laboratory analytes were included as TEAEs.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Single Ascending Dose Cohorts |
| AMG 890 | EXPERIMENTAL | Single Ascending Dose Cohorts |
| Name | Type | Description |
|---|---|---|
| AMG 890 | DRUG | Ascending Single Doses of AMG 890 |
| Placebo | DRUG | Calculated volume to match experimental drug. |
Inclusion Criteria: * Men and women with ages between 18 and 70 years old, inclusive. * Protocol-defined elevated plasma Lp(a) level. * Body mass index (BMI) greater than or equal to 18 and less than or equal to 40 kg/m2, at screening. * Women must be of non-reproductive potential. * Other Inclusio...