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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04289285 | Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia | PHASE3 | COMPLETED | 804 | — | — | Apr 29, 2020 | Feb 9, 2022 | Apr 11, 2022 | 1 | China |
| Arm | Type | Description |
|---|---|---|
| IBI306 450mg SC Q4W | EXPERIMENTAL | - |
| Placebo SC Q4W | PLACEBO_COMPARATOR | - |
| IBI306 600mg SC Q6W | EXPERIMENTAL | - |
| Placebo SC Q6W | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| IBI306 450mg SC Q4W | DRUG | Subjects will receive IBI306 450mg every 4 weeks subcutaneously. |
| Placebo SC Q4W | DRUG | Subjects will receive placebo every 4 weeks subcutaneously. |
| IBI306 600mg SC Q6W | DRUG | Subjects will receive IBI306 600mg every 6 weeks subcutaneously. |
| Placebo SC Q6W | OTHER | Subjects will receive placebo every 6 weeks subcutaneously. |
Inclusion criteria: 1. Males and females ≥ 18 to ≤ 75 years of age 2. Diagnosis of hypercholesterolemia 3. LDL cholesterol ≥ 70 mg/dl (1.8mmol/L) 4. Very high or high cardiovascular risk 5. TG≤500 mg/dL(5.64 mmol/L) Exclusion criteria: 1. Diagnosis of HoFH or HeFH 2. Uncontrolled hypertension 3. ...