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Monoclonal Antibodies

Ezetimibe for High Cholesterol

Phase 3
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 24, 68 and 104
Awards & highlights

Study Summary

This trial is testing the effectiveness of a drug called alirocumab in reducing LDL cholesterol levels in children with a condition called heterozygous familial hypercholesterolemia. The trial will last 24 weeks and will compare children taking alirocumab every 2 weeks or every 4 weeks to children taking a placebo. The trial will also look at safety and tolerability of the drug.

Eligible Conditions
  • High Cholesterol

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 24, 68 and 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 24, 68 and 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DB Period: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24: Intent-to-treat (ITT) Estimand
Secondary outcome measures
Change From Baseline in Cogstate Battery Test - Overall Composite Score at Weeks 24, 68 and 104
DB Period: Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 12 and 24: ITT Estimand
DB Period: Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 12 and 24: On-treatment Estimand
+39 more

Side effects data

From 2008 Phase 4 trial • 30 Patients • NCT00203476
50%
Flushing
10%
Loose Stools
10%
Elevated LFTs
100%
80%
60%
40%
20%
0%
Study treatment Arm
Niacin
Colestipol
Ezetimibe

Trial Design

4Treatment groups
Experimental Treatment
Group I: Placebo/Alirocumab Q4WExperimental Treatment13 Interventions
Participants received SC injection of placebo (matched to alirocumab) based on their BW (<50 kg or >=50 kg) Q4W for 24 weeks in DB treatment period added to stable LMT. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 150 mg (for BW <50 kg) or 300 mg (for BW >=50 kg) Q4W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 150 mg to 300 mg when BW increased from <50 kg to >=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 150 mg Q4W to 75 mg Q2W (for BW <50 kg) or 300 mg Q4W to 150 mg Q2W (for BW >=50 kg) or down titrated as 75 mg Q2W to 40 mg Q2W (for BW <50 kg) or 150 mg Q2W to 75 mg Q2W (for BW >=50 kg).
Group II: Placebo/Alirocumab Q2WExperimental Treatment13 Interventions
Participants received subcutaneous (SC) injection of placebo (matched to alirocumab) based on their body weight (BW) (less than [<] 50 kilograms [kg] or greater than or equal to [>=] 50 kg) Q2W for 24 weeks in DB treatment period added to stable LMT. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 milligrams (mg) (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from <50 kg to >=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW <50 kg) or 75 mg to 150 mg (for BW >=50 kg) or down titrated as 75 mg to 40 mg (for BW <50 kg) or 150 mg to 75 mg (for BW >=50 kg).
Group III: Alirocumab Q4WExperimental Treatment12 Interventions
Participants received SC injection of alirocumab 150 mg (for BW <50 kg) or 300 mg (for BW >=50 kg) Q4W for 24 weeks in DB treatment period added to stable LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level >=110 mg/dL (2.85 mmol/L) at Week 8. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 150 mg (for BW <50 kg) or 300 mg (for BW >=50 kg) from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 150 mg to 300 mg when BW increased from <50 kg to >=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 150 mg Q4W to 75 mg Q2W (for BW <50 kg) or 300 mg Q4W to 150 mg Q2W (for BW >=50 kg) or down titrated as 75 mg Q2W to 40 mg Q2W (for BW <50 kg) or 150 mg Q2W to 75 mg Q2W (for BW >=50 kg).
Group IV: Alirocumab Q2WExperimental Treatment12 Interventions
Participants received SC injection of alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) Q2W for 24 weeks in DB treatment period added to stable LMT. Alirocumab dose was up-titrated to 75 mg or 150 mg Q2W from Week 12, when LDL-C level was >=110 milligrams per deciliter (mg/dL) (2.85 millimoles per liter [mmol/L]) at Week 8. After completion of DB treatment period, eligible participants entered into OL treatment period and received alirocumab 40 mg (for BW <50 kg) or 75 mg (for BW >=50 kg) from Week 24 up to an additional 80 weeks (i.e., up to Week 104) added to stable LMT. After Week 24, dose up-titrated from 40 mg to 75 mg when BW increased from <50 kg to >=50 kg. From Week 32 up to Week 104, based on participant LDL-C value, alirocumab dose was either up-titrated as 40 mg to 75 mg (for BW <50 kg) or 75 mg to 150 mg (for BW >=50 kg) or down titrated as 75 mg to 40 mg (for BW <50 kg) or 150 mg to 75 mg (for BW >=50 kg).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotinic acid
2018
Completed Phase 4
~720
Ezetimibe
2009
Completed Phase 4
~6470
Cholestyramine
2018
Completed Phase 4
~340
Fluvastatin
2018
Completed Phase 4
~2206310
Alirocumab SAR236553 (REGN727)
2018
Completed Phase 3
~180
Rosuvastatin
2019
Completed Phase 4
~3150
Atorvastatin
1998
Completed Phase 4
~10900
Fenofibrate
2018
Completed Phase 4
~6500
Omega-3 fatty acids
2018
Completed Phase 4
~2640
Placebo
1995
Completed Phase 3
~2670
Pravastatin
2010
Completed Phase 4
~11530
Simvastatin
2012
Completed Phase 4
~1270
Lovastatin
2008
Completed Phase 4
~2205100

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,681 Total Patients Enrolled
4 Trials studying High Cholesterol
735 Patients Enrolled for High Cholesterol
SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,314 Total Patients Enrolled
4 Trials studying High Cholesterol
735 Patients Enrolled for High Cholesterol
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,133 Total Patients Enrolled
4 Trials studying High Cholesterol
735 Patients Enrolled for High Cholesterol

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
2018. "An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03510884.
~22 spots leftby Apr 2025
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