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Home › Medications › alirocumab

alirocumab

4 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials of alirocumab

30 trials tracked of alirocumab: 23 in phase 3 or 4 and 11 with published results. The most-cited published study has 196 citations.

30Trials tracked
23Phase 3 & 4
0Recruiting
11With published results
Phase distribution
Phase 4 2 Phase 3 21 Phase 2 6 Phase 1 1
  1. Phase 3 Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy Completed · 196 cited
  2. Phase 3 Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH) Completed · 167 cited
  3. Phase 3 Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin) Completed · 140 cited
  4. Phase 4 Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia) Completed · 127 cited
  5. Phase 3 Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan Completed · 127 cited
  6. Phase 3 Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1) Completed · 127 cited
Show 24 more trials
  1. Phase 3 Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II) Completed · 102 cited
  2. Phase 3 Open Label Study of Long Term Safety Evaluation of Alirocumab Completed · 58 cited
  3. Phase 3 Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia Completed · 51 cited
  4. Phase 3 ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab Completed · 25 cited
  5. Phase 3 Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin Completed · 22 cited
  6. Phase 4 Alirocumab in Patients With Acute Myocardial Infarction Completed
  7. Phase 3 Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN) Completed
  8. Phase 3 Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I) Completed
  9. Phase 3 Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II) Completed
  10. Phase 3 Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy Completed
  11. Phase 3 Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II) Completed
  12. Phase 3 Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy) Completed
  13. Phase 3 Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I) Completed
  14. Phase 3 Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia Completed
  15. Phase 3 Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH) Completed
  16. Phase 3 Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE) Completed
  17. Phase 3 Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term) Completed
  18. Phase 2 Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia Completed
  19. Phase 2 Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan Completed
  20. Phase 2 Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy Completed
  21. Phase 2 Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) Completed
  22. Phase 2 Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia Completed
  23. Phase 2 A Study of Alirocumab in Participants With Autosomal Dominant Hypercholesterolemia (ADH) and Gain-of-Function Mutations (GOFm) of the Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Gene or Loss-of-Function Mutations (LOFm) of the Apolipoprotein (Apo) B Gene Completed
  24. Phase 1 Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors Completed

Showing the 30 most-cited and recently-updated of 30 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
PCSK9 inhibitors significantly reduce LDL-C levels in patients with atherosclerotic cardiovascular disease
Cardiology Meta-analysis
PCSK9 inhibitors significantly reduce LDL-C levels in patients with atherosclerotic cardiovascular disease PCSK9 inhibitors lower LDL but not stroke risk
This meta-analysis of 63,328 patients evaluated the efficacy and cost-effectiveness of alirocumab, evolocumab, and inclisiran compared to st…
A large meta-analysis finds PCSK9 inhibitors cut LDL and heart attacks, but stroke risk was unchanged. Evolocumab may offer the best value.
Frontiers Aug 9, 2026
PCSK9 inhibitors reduce LDL-C by 35.44% in children with heterozygous familial hypercholesterolaemia
Cardiology Sys. Review
PCSK9 inhibitors reduce LDL-C by 35.44% in children with heterozygous familial hypercholesterolaemia PCSK9 inhibitors lower LDL cholesterol in children with high risk
This systematic review and meta-analysis of randomized controlled trials found that PCSK9 inhibitors as add-on therapy significantly reduced…
New data shows PCSK9 inhibitors significantly lower bad cholesterol in children who do not reach health goals on standard medications.
medRxiv Aug 9, 2026
PCSK9 monoclonal antibodies show promise for renal benefit in diabetic kidney disease
Diabetes & Endocrinology Sys. Review
PCSK9 monoclonal antibodies show promise for renal benefit in diabetic kidney disease Newer antibody treatments show mixed results for diabetic kidney disease
This narrative review evaluates various monoclonal antibodies, including TGF-beta1, VEGF-B, CTGF, and PCSK9 inhibitors, for the treatment of…
While some antibody therapies failed to help kidneys in diabetes, others like PCSK9 inhibitors show promise by targeting lipids and local ti…
Frontiers Jul 9, 2026
Corrective re-analysis suggests Lp(a) reduction accounts for 57-70% of PCSK9 inhibitor benefit in ASCVD
Cardiology Phase III
Corrective re-analysis suggests Lp(a) reduction accounts for 57-70% of PCSK9 inhibitor benefit in ASCVD Re-analysis suggests most PCSK9 inhibitor benefit comes from lowering Lp(a)
This Phase 3 corrective re-analysis of cardiovascular outcomes trial data in secondary prevention populations with ASCVD evaluated the role …
Researchers re-analyzed data from Phase 3 trials of alirocumab and evolocumab in patients with atherosclerotic cardiovascular disease.
medRxiv Apr 16, 2026