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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02597127 | Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C) | PHASE2 | COMPLETED | 501 | — | — | Jan 1, 2016 | Jun 7, 2017 | May 17, 2019 | 54 | United States, Canada +3 |
Percent Change in LDL-C (beta-quantification) from Baseline to Day 180 in MITT Population
| Arm | Type | Description |
|---|---|---|
| ALN-PCSSC 200 mg (bi-annual dosing) | EXPERIMENTAL | ALN-PCSSC 200 milligram (mg) SC administration once at Day 1 |
| ALN-PCSSC 300 mg (bi-annual dosing) | EXPERIMENTAL | ALN-PCSSC 300 mg SC administration once at Day 1 |
| ALN-PCSSC 500 mg (bi-annual dosing) | EXPERIMENTAL | ALN-PCSSC 500 mg SC administration once at Day 1 |
| Normal Saline (bi-annual dosing) | PLACEBO_COMPARATOR | Saline SC administration once at Day 1 |
| ALN-PCSSC 100 mg (quarterly dosing) | EXPERIMENTAL | ALN-PCSSC 100 mg SC administration twice at Day 1 and Day 90 |
| ALN-PCSSC 200 mg (quarterly dosing) | EXPERIMENTAL | ALN-PCSSC 200 mg SC administration twice at Day 1 and Day 90 |
| ALN-PCSSC 300 mg (quarterly dosing) | EXPERIMENTAL | ALN-PCSSC 300 mg SC administration twice at Day 1 and Day 90 |
| Normal Saline (quarterly dosing) | PLACEBO_COMPARATOR | Saline SC administration twice at Day 1 and Day 90 |
| Name | Type | Description |
|---|---|---|
| ALN-PCSSC | DRUG | ALN-PCSSC is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis and is given as SC injections |
| Normal Saline | DRUG | Saline (sterile, normal, 0.9%) solution given as SC injections |
Inclusion Criteria: 1. Male or female participants ≥18 years of age. 2. History of ASCVD or ASCVD-risk equivalents (symptomatic atherosclerosis, Type 2 diabetes, familial hypercholesterolemia, including participants whose 10-year risk of a CV event assessed by Framingham Risk Score (Framingham Risk...