Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
lerodalcibep · 4 trials · 6 indications
Percent LDL-C change from baseline
comparison of free PCSK9 reductions from baseline between P1 and P2
comparison of serum lerodalcibep Cmax between P1 and P2
comparison of serum lerodalcibep AUC 0-last between P1 and P2
comparison of serum lerodalcibep T-HALF between P1 and P2
Blood samples were collected at baseline and Week 24 to determine mean percent change in LDL-C (calculated by the Friedwald formula). Percent change from baseline determined using analysis of covariance (ANCOVA) model with treatment and CVD status as factors and baseline LDL-C value as covariate.
Blood samples were collected at baseline Week 22 and Week 24 to determine mean percent change in LDL-C (calculated by the Friedwald formula). Percent change from baseline determined using analysis of covariance (ANCOVA) model with treatment and CVD status as factors and baseline LDL-C value as covariate.
Evaluation of Adverse Events based on MedRA based on ITT population
| Arm | Type | Description |
|---|---|---|
| lerodalcibep | EXPERIMENTAL | 300 mg SC dosed monthly |
| inclisiran | ACTIVE_COMPARATOR | 284 mg SC dosed Day 1 and Day 90 |
| LIB003 (lerodalcibep) Process 1 | EXPERIMENTAL | 300 mg LIB003 Process 1 drug product administered SC |
| LIB003 (lerodalcibep) Process 2 | ACTIVE_COMPARATOR | 300 mg LIB003 Process 2 drug product administered SC |
| LIB003 (lerodalcibep) | EXPERIMENTAL | 300 mg (1.2 mL) SC Q4W |
| Placebo | PLACEBO_COMPARATOR | 1.2 mL SC Q4W |
| Name | Type | Description |
|---|---|---|
| lerodalcibep | BIOLOGICAL | 300 mg |
| Inclisiran | DRUG | 284 mg |
Inclusion Criteria: * Provision of signed informed consent prior to any study-specific procedure; * Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥16 and ≤42 kg/m2; * Very- high or high risk for CVD as defined in 2019 ESC/EAS Guidelines * High-intensity statin (daily atorvastatin 40/80 or rosu...