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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04823611 | A Study of AZD8233 in Participants With Dyslipidemia. | PHASE1 | COMPLETED | 87 | — | — | Jan 20, 2021 | Sep 10, 2022 | Dec 24, 2024 | 7 | Japan |
Part B: Change from baseline in LDL-C at week 12. Results are based on Mixed Model Repeated Measures (MMRM) analysis on the log-transformed change from baseline. Log-transformed change from baseline is calculated as the visit value in log minus the baseline value in log. The results from the model are then back transformed. Note: log(week 12 data) - log(baseline data) = log(week12/baseline), which is a ratio
| Arm | Type | Description |
|---|---|---|
| Part A:Placebo | PLACEBO_COMPARATOR | Placebo solution for subcutaneous injection. |
| Part A:AZD8233 | EXPERIMENTAL | AZD8233 for subcutaneous injection. |
| Part B:Placebo | PLACEBO_COMPARATOR | Placebo solution for subcutaneous injection. |
| Part B:AZD8233 medium dose | EXPERIMENTAL | AZD8233 medium dose for subcutaneous injection. |
| Part B:AZD8233 low dose | EXPERIMENTAL | AZD8233 low dose for subcutaneous injection. |
| Part C: Placebo | PLACEBO_COMPARATOR | Placebo solution for subcutaneous injection. |
| Part C: AZD8233 medium dose | EXPERIMENTAL | AZD8233 medium dose for subcutaneous injection. |
| Name | Type | Description |
|---|---|---|
| Part A:Placebo | DRUG | Placebo solution |
| Part A:AZD8233 | DRUG | PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. |
| Part B:Placebo | DRUG | Placebo solution |
| Part B:AZD8233 | DRUG | PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. |
| Part C: Placebo | DRUG | Placebo solution |
| Part C: AZD8233 | DRUG | PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. |
Key Inclusion Criteria: Part A * Participants must be 20 to 60 years of age inclusive, at the time of signing the informed consent * Participants who have a fasting LDL-C ≥ 70 mg/dL but \< 140 mg/dL at screening * Participants who have fasting triglycerides \< 400 mg/dL at screening * Participants...