Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan
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ClinicalTrials.gov Identifier: NCT01812707 |
Recruitment Status :
Completed
First Posted : March 18, 2013
Results First Posted : September 24, 2015
Last Update Posted : October 4, 2016
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypercholesterolemia | Drug: Alirocumab Drug: Placebo (for alirocumab) Drug: Atorvastatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Three Doses of SAR236553 (REGN727) Over 12 Weeks in Patients With Primary Hypercholesterolemia and LDL-cholesterol ≥100 mg/dL (≥2.59 mmol/L) on Ongoing Stable Atorvastatin Therapy |
Study Start Date : | March 2013 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | January 2014 |

Arm | Intervention/treatment |
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Placebo Comparator: Placebo
Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
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Drug: Placebo (for alirocumab)
Two subcutaneous (SC) injections in the abdomen only Route of administration: subcutaneous injection (1 mL) in the abdomen Drug: Atorvastatin Orally once daily at a stable dose of 5 to 20 mg as background therapy Route of administration: oral administration in the evening |
Experimental: Alirocumab 50 mg Q2W
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
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Drug: Alirocumab
Two SC injections in the abdomen only
Other Names:
Drug: Atorvastatin Orally once daily at a stable dose of 5 to 20 mg as background therapy Route of administration: oral administration in the evening |
Experimental: Alirocumab 75 mg Q2W
Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
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Drug: Alirocumab
Two SC injections in the abdomen only
Other Names:
Drug: Atorvastatin Orally once daily at a stable dose of 5 to 20 mg as background therapy Route of administration: oral administration in the evening |
Placebo Comparator: Alirocumab 150 mg Q2W
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
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Drug: Alirocumab
Two SC injections in the abdomen only
Other Names:
Drug: Atorvastatin Orally once daily at a stable dose of 5 to 20 mg as background therapy Route of administration: oral administration in the evening |
- Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis [ Time Frame: Baseline to Week 12 (LOCF) ]Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.
- Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis [ Time Frame: Baseline to Week 12 (LOCF) ]Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
- Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis [ Time Frame: Baseline to Week 12 (LOCF) ]Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
- Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis [ Time Frame: Week 12 (LOCF) ]
- Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis [ Time Frame: Baseline to Week 12 (LOCF) ]Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
- Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis [ Time Frame: Baseline to Week 12 (LOCF) ]Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (inter-quartile range).
- Absolute Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) Ratio at Week 12 - On-Treatment Analysis [ Time Frame: From Baseline to Week 12 (LOCF) ]Adjusted LS mean and standard errors were estimated using the same ANCOVA as for primary endpoint.

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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria :
- Participants with primary hypercholesterolemia treated with atorvastatin at stable dose of 5-20 mg for at least 6 weeks prior to screening and likely to have LDL-C ≥100 mg/dL (≥2.59 mmol/L) at the screening visit.
OR
- Participants with primary hypercholesterolemia who were receiving a lipid-lowering treatment other than atorvastatin, or who were not at stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening if they were likely to have LDL-C ≥100 mg/dL (≥2.59 mmol/L) after a 6-week run-in treatment period on atorvastatin therapy.
Exclusion criteria:
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LDL-C <100 mg/dL (<2.59 mmol/L)
- at screening visit for participants who were being treated with stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening OR
- at the end of the 6-week run-in period on atorvastatin for participants receiving a lipid lowering treatment other than atorvastatin, or not at stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening
- Participants with type 1 diabetes
- Participants with type 2 diabetes treated with insulin, or without, and considered poorly controlled at screening.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812707
Japan | |
Investigational Site Number 392002 | |
Koganei-Shi, Japan | |
Investigational Site Number 392001 | |
Shinjuku-Ku, Japan | |
Investigational Site Number 392003 | |
Suita-Shi, Japan | |
Investigational Site Number 392004 | |
Suita-Shi, Japan |
Study Director: | Clinical Sciences & Operations | Sanofi |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01812707 |
Other Study ID Numbers: |
DFI12361 U1111-1134-4749 ( Other Identifier: UTN ) |
First Posted: | March 18, 2013 Key Record Dates |
Results First Posted: | September 24, 2015 |
Last Update Posted: | October 4, 2016 |
Last Verified: | August 2015 |
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Antibodies, Monoclonal Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Immunologic Factors Physiological Effects of Drugs |