Sanofi: Hypercholesterolemia trials

The registry lists 38 Hypercholesterolemia studies with Sanofi as lead sponsor. 0 are open to participants now and 22 have results posted.

Phase 1 9Phase 2 6Phase 3 22Phase 4 1(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial HypercholesterolemiaCompletedNCT03510884Phase 3Results posted
• An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial HypercholesterolemiaCompletedNCT03510715Phase 3Results posted
• Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying TherapyCompletedNCT03415178Phase 3Results posted
• Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With HypercholesterolemiaCompletedNCT02984982Phase 4Results posted
• An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial HypercholesterolemiaCompletedNCT02890992Phase 2Results posted
• Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With HypercholesterolemiaCompletedNCT02715726Phase 3Results posted
• 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)CompletedNCT02585778Phase 3Results posted
• Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of StatinCompletedNCT02584504Phase 3Results posted
• Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)CompletedNCT02476006Phase 3Results posted
• Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and TaiwanCompletedNCT02289963Phase 3Results posted
• 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)CompletedNCT02107898Phase 3Results posted
• Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)CompletedNCT02023879Phase 3Results posted
• Open Label Study of Long Term Safety Evaluation of AlirocumabCompletedNCT01954394Phase 3Results posted
• Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in JapanCompletedNCT01812707Phase 2Results posted
• Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With HypercholesterolemiaCompletedNCT01644474Phase 3Results posted
• Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)CompletedNCT01644188Phase 3Results posted
• 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)CompletedNCT01644175Phase 3Results posted
• 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 TherapyCompletedNCT01623115Phase 3Results posted
• Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)CompletedNCT01617655Phase 3Results posted
• 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)CompletedNCT01507831Phase 3Results posted
• Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary HypercholesterolemiaCompletedNCT01288469Phase 2Results posted
• Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin TherapyCompletedNCT01288443Phase 2Results posted
• A Study to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia Not Adequately Controlled on Statin TherapyCompletedNCT04669041Phase 3
• A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese SubjectsCompletedNCT02979015Phase 1
• Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-CholesterolCompletedNCT01959971Phase 1
• Pharmacokinetic of Alirocumab SAR236553 (REGN727) Administered Subcutaneously at 3 Different Injection Sites in Healthy SubjectsCompletedNCT01785329Phase 1
• Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy SubjectsCompletedNCT01723735Phase 1
• Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy SubjectsCompletedNCT01670734Phase 1
• Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy VolunteersCompletedNCT01448317Phase 1
• Study of the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Alirocumab SAR236553 (REGN727)CompletedNCT01448304Phase 1
• Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)CompletedNCT01448239Phase 1
• Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy SubjectsCompletedNCT01443650Phase 1
• Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe HypercholesterolemiaTerminatedNCT00766688Phase 3
• Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary HypercholesterolemiaTerminatedNCT00741715Phase 3
• Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing Statins in Patients With Primary HypercholesterolemiaTerminatedNCT00729027Phase 3
• Evaluation of Efficacy and Safety of AVE5530 in Patients With Primary HypercholesterolemiaTerminatedNCT00718965Phase 3
• A Multicenter, Active and Placebo-controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate HypercholesteremiaCompletedNCT00690937Phase 2
• A Study Evaluating the Safety and Efficacy of AVE5530 (4 Weeks) in Patients With Mild to Moderate HypercholesterolemiaCompletedNCT00440154Phase 2