Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia
NCT ID: NCT01266876
Last Updated: 2015-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
77 participants
INTERVENTIONAL
2011-01-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Placebo
Placebo two SC injections in the abdomen only.
Alirocumab 150 mg Q4W
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab
Alirocumab two SC injections in the abdomen only.
Alirocumab 200 mg Q4W
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab
Alirocumab two SC injections in the abdomen only.
Alirocumab 300 mg Q4W
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab
Alirocumab two SC injections in the abdomen only.
Alirocumab 150 mg Q2W
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab
Alirocumab two SC injections in the abdomen only.
Interventions
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Alirocumab
Alirocumab two SC injections in the abdomen only.
Placebo
Placebo two SC injections in the abdomen only.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants must be on a stable statin dose, with or without ezetimibe, for at least 6 weeks before screening
3. Serum LDL-C levels ≥ 100 mg/dL at screening
4. Willing to follow the NCEP ATPIII TLC diet, or an equivalent diet plan, starting at screening and continuing until the last study visit
5. A negative urine/serum pregnancy test at each screening visit and start of the study, for women of childbearing potential
Exclusion Criteria
2. Use of a medication (other than a statin or EZE) to alter serum lipids within 42 days (6 weeks) before screening including, but not limited to:
* Fibrates
* Niacin (\>500 mg/day)
* Omega-3 fatty acids (\>1000 mg/day of DHA/EPA)
* Bile acid resins
3. Use of nutraceuticals or OTC medications that may alter lipid levels that are not stable for at least 6 weeks before screening and are not planned to remain constant throughout the study. Examples include:
* Omega-3 fatty acids (≤1000 mg/day of DHA/EPA)
* Niacin (≤500 mg/day)
* Plant stanols, such as found in Benecol, flax seed oil, psyllium
* Red yeast rice
4. Disorders known to influence lipid levels, such as nephrotic syndrome, significant liver disease, Cushing's disease, untreated hypothyroidism (patients on stable thyroid replacement for at least 12 weeks before the full screening visit, who are metabolically euthyroid by thyroid-stimulating hormone (TSH) testing are allowed)
5. Use of thyroid medications (except for replacement therapy which has been stable for at least 12 weeks before the full screening visit)
6. Fasting serum TG \>350 mg/dL screening
7. LDL apheresis within 12 months before screening
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Port Orange, Florida, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Auburn, Maine, United States
Biddeford, Maine, United States
St Louis, Missouri, United States
Concord, New Hampshire, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Winnipeg, Manitoba, Canada
London, Ontario, Canada
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
Saint Foy, Quebec, Canada
Huntsville, Alabama, United States
Mission Viejo, California, United States
Newport Beach, California, United States
Bridgeport, Connecticut, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Countries
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References
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Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.
Defesche JC, Stefanutti C, Langslet G, Hopkins PN, Seiz W, Baccara-Dinet MT, Hamon SC, Banerjee P, Kastelein JJP. Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1338-1346.e7. doi: 10.1016/j.jacl.2017.08.016. Epub 2017 Sep 4.
Toth PP, Hamon SC, Jones SR, Martin SS, Joshi PH, Kulkarni KR, Banerjee P, Hanotin C, Roth EM, McKenney JM. Effect of alirocumab on specific lipoprotein non-high-density lipoprotein cholesterol and subfractions as measured by the vertical auto profile method: analysis of 3 randomized trials versus placebo. Lipids Health Dis. 2016 Feb 13;15:28. doi: 10.1186/s12944-016-0197-4.
Stein EA, Gipe D, Bergeron J, Gaudet D, Weiss R, Dufour R, Wu R, Pordy R. Effect of a monoclonal antibody to PCSK9, REGN727/SAR236553, to reduce low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolaemia on stable statin dose with or without ezetimibe therapy: a phase 2 randomised controlled trial. Lancet. 2012 Jul 7;380(9836):29-36. doi: 10.1016/S0140-6736(12)60771-5. Epub 2012 May 26.
Other Identifiers
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R727-CL-1003
Identifier Type: -
Identifier Source: org_study_id
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