Heterozygous Familial Hypercholesterolemia (HeFH)
Conditions
Brief summary
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24, Number of participants with one or more adverse events (AEs), Number of participants who discontinue study drug due to an AE
Detailed description
Mean percent change from baseline in LDL-C at Week 52, Mean percent change from baseline in non-high-density lipoprotein cholesterol (HDL-C) at Week 24, Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24, Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24, Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 24, Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 24
Interventions
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24, Number of participants with one or more adverse events (AEs), Number of participants who discontinue study drug due to an AE | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean percent change from baseline in LDL-C at Week 52, Mean percent change from baseline in non-high-density lipoprotein cholesterol (HDL-C) at Week 24, Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24, Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24, Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 24, Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 24 | — |
Countries
Czechia, Finland, Hungary, Netherlands, Norway, Spain
Outcome results
None listed