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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07253584 | A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of SAL003 in Combination With Statin Therapy in Patients With Hypercholesterolemia and Mixed Dyslipidemia | PHASE3 | COMPLETED | 720 | — | — | Dec 19, 2023 | Jun 30, 2025 | Nov 28, 2025 | 1 | China |
Percent change from baseline in LDL-C at Week 24.
| Arm | Type | Description |
|---|---|---|
| Test Group | EXPERIMENTAL | SAL003 140 mg |
| Reference Group | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| SAL003 140 mg | DRUG | SAL003 140 mg |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Subjects aged 18 to 75 years. * On a stable, moderate- to high-intensity statin regimen (with or without ezetimibe) for at least 4 weeks prior to screening. * Fasting LDL-C above target levels per 2023 Chinese guidelines: With ASCVD history: ≥1.4 mmol/L (Extreme Risk) or ≥1.8...