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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01437059 | Trial to Evaluate Safety and Tolerability of ALN-PCS02 in Subjects With Elevated LDL-Cholesterol (LDL-C) | PHASE1 | COMPLETED | 32 | — | — | Sep 1, 2011 | Sep 1, 2012 | Oct 12, 2012 | 2 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| ALN-PCS02 | ACTIVE_COMPARATOR | - |
| Sterile Normal Saline (0.9% NaCl) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ALN-PCS02 | DRUG | Dose levels between 15 and 400 μg/kg by intravenous (IV) infusion |
| Sterile Normal Saline (0.9% NaCl) | DRUG | Calculated volume to match active comparator |
Inclusion Criteria: * Elevated LDL-C of \>3.0 mmol/L and \<5.7 mmol/L * Fasting triglyceride concentration ≤2.8 mmol/L * Body weight \>60.0 kg; body mass index (BMI) between 19.00 kg/m2 and \<35.00 kg/m2 * Adequate blood counts, liver and renal function * May not received any lipid lowering drug/ag...