Hypercholesterolemia
Conditions
Keywords
Obesity, Elevated Low-Density Lipoprotein Cholesterol (LDL-C) Levels
Brief summary
This study is researching an experimental drug called alirocumab, referred to as "study drug". In the United States, alirocumab is approved for the treatment of hypercholesterolemia (high blood cholesterol levels). The aim of the study is to see how safe and effective alirocumab is when given weekly to adult participants who have hypercholesterolemia. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug once a week * How much study drug is in the blood at different times
Interventions
DRUGAlirocumab
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1\. Participant has elevated LDL-C level, as defined in the protocol Key
Exclusion criteria
1. Participant plans to initiate or change dose of lipid-lowering therapy 2. Use of any PCSK9 inhibitors NOTE: Other Protocol-Defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in LDL-C | From Baseline through Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Concentrations of total alirocumab in serum | Through Week 20 |
| Concentrations of free Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) in serum | Through Week 20 |
| Percent change in LDL-C | From Baseline through Week 8 |
| Percent change in total cholesterol | From Baseline through Week 12 |
| Percent change in non-High-Density Lipoprotein-Cholesterol (HDL-C) | From Baseline through Week 12 |
| Percent change in HDL-C | From Baseline through Week 12 |
| Percent change in triglycerides | From Baseline through Week 12 |
| Percent change in Apolipoprotein B (ApoB) | From Baseline through Week 12 |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Through Week 20 |
| Severity of TEAEs | Through Week 20 |
Countries
United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed