Clinical Trial Search

Primary: Familial Hypercholesterolemia (FH) Determination for Family Members of School Children With Elevated Cholesterol and Documented FH Variant — 3; 8 participants

Primary: Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period — -49.17 Percent Change

Primary: Number of LDLR Gene Mutations — 7 gene mutations

Primary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point — -3.31; -24.66 percentage of baseline — p=<0.001

Primary: Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 — -16.5 percent change

Primary: Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 (Intent-to-Treat [ITT] Estimand) — 1.9; -47.1 Percent Change — p=< 0.0001

Primary: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 — 1.12; -42.70; -55.24 percent change — p=<0.001

Primary: Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) — -45.5 Percent Change

Primary: Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150 — 2.39; 0.70 Percentage change — p=0.9047

Primary: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 — -0.3; -54.2 percent change — p=<0.001

Primary: Percent Change From Baseline in LDL-C at Week 12 — -2.02; 5.53; -61.25; -55.74 percent change — p=<0.001

Primary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) — -40.1 Percent Change

Primary: LDL-Cholesterol (mg/dL) — 396.0; 481.4 mg/dL — p=0.005

Primary: Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12 (Intent-to-Treat [ITT] Estimand) — 8.6; -26.9 Percentage of change — p=<0.0001

Primary: Percent Change From Baseline To Primary Endpoint Visit (PET) In LDL-C In Cohort 1 — -27.17; -6.77; -22.96; -10.62 Percent

Primary: Mean Percent Change in LDL-C From Baseline To Week 12 — -10.6; 8.2 percent change — p=<0.0001

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 10 Participants

Primary: Percentage Change From Day 1 to Day 90 in LDL-C — -12.26 percent change

Primary: The Number of Participants Who Experianced Adverse Events and Serious Adverse Events — 5 participants

Primary: Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis — -10.7; -28.9; -31.5; -42.5 percent change — p=0.0000

Primary: Percent Change From Baseline in LDL-C at Day 28 — -25.54 Percent Change — p=0.0041

Primary: Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F) — 553; 543 L/hr

Primary: Percentage Change in LDL-C From Baseline to Day 330 (Part 1/Year 1) — -21.6; 11.7 percent change in LDL-C

Primary: Number of Participants With Adverse Events — 94; 174; 76; 143 Participants

Primary: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent--to--Treat (ITT) Analysis — -48.7; 2.8 percent change — p=<0.0001

Primary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) — -16.2; -2.6; -32.4; 30.6 percentage of baseline

Primary: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12: Intent-to-Treat (ITT) Analysis — -4.1 percent change

Primary: Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand) — 8.8; -29.7; -44.0; -47.2 Percent…

Primary: Absolute Change From Baseline to Month 3 in Fasting Triglycerides (TG) — -550.00 mg/dL

Primary: Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C — -45.58; 3.03 percent change from baseline — p=<.0001