Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan

Sponsor
Sanofi
Study ID
NCT01812707
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab — DRUG
    Two SC injections in the abdomen only
  • Placebo (for alirocumab) — DRUG
    Two subcutaneous (SC) injections in the abdomen only Route of administration: subcutaneous injection (1 mL) in the abdomen
  • Atorvastatin — DRUG
    Orally once daily at a stable dose of 5 to 20 mg as background therapy Route of administration: oral administration in the evening

Study Details

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9). Primary Objective of the study: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥100 mg/dL (≥2.59 mmol/L) on ongoing stable atorvastatin therapy. Secondary Objectives: * To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo * To evaluate the safety and tolerability of alirocumab * To evaluate the development of anti-alirocumab antibodies * To evaluate the pharmacokinetics of alirocumab

Key Dates

Start date
Mar 31, 2013
Status verified
Aug 2015
Primary completion
Jan 31, 2014
Completion
Jan 31, 2014

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
  • Experimental: Alirocumab 50 mg Q2W
    Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
  • Experimental: Alirocumab 75 mg Q2W
    Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
  • Placebo Comparator: Alirocumab 150 mg Q2W
    Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.

Primary Outcome Measure

Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis [ Time Frame: Baseline to Week 12 (LOCF) ]

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