Conditions: Hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 77
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy and safety of REGN727/SAR236553 in participants diagnosed with heterozygous familial hypercholesterolemia (heFH)

Detailed description:

Arms:
arm 1: Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. arm 2: Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. arm 3: Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. arm 4: Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. arm 5: Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Interventions: intervention 1: Alirocumab intervention 2: Placebo
Intervention descriptions: intervention 1: Alirocumab two SC injections in the abdomen only. intervention 2: Placebo two SC injections in the abdomen only.

Protocol document: