Novartis: Hypercholesterolemia trials

The registry lists 36 Hypercholesterolemia studies with Novartis as lead sponsor. 6 are open to participants now and 10 have results posted.

Phase 1 3Phase 2 2Phase 3 17Phase 4 4No phase 10(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.

• A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant HypercholesterolemiaRecruitingNCT07610278Phase 2
• Real World Adherence of PCSK9 Targeted TherapyNot yet recruitingNCT07468500
• Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)RecruitingNCT06770543
• Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial HypercholesterolemiaRecruitingNCT06597019Phase 3
• Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial HypercholesterolemiaRecruitingNCT06597006Phase 3
• LATAM LOWERS LDL-CRecruitingNCT06501443Phase 4
• Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.CompletedNCT05888103Phase 3Results posted
• Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.CompletedNCT05763875Phase 3Results posted
• Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With HypercholesterolemiaCompletedNCT05192941Phase 4Results posted
• A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)CompletedNCT04929249Phase 3Results posted
• Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary SyndromeCompletedNCT04873934Phase 3Results posted
• Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-CCompletedNCT04666298Phase 2Results posted
• Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-CCompletedNCT03814187Phase 3Results posted
• Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein CholesterolCompletedNCT03400800Phase 3Results posted
• Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein CholesterolCompletedNCT03399370Phase 3Results posted
• Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)CompletedNCT03397121Phase 3Results posted
• A Study to Assess the Real-World Effectiveness of Inclisiran and PCSK9 mAbs in Chinese Hypercholesterolemia Adult PatientsCompletedNCT07409636
• A Real-world Study to Assess the Characteristics and Long-term Effectiveness of Inclisiran in Chinese Adult PatientsCompletedNCT06595069
• A Real-world Study of Inclisiran Adherence, Treatment Patterns, Patient Characteristics, and Effectiveness in ASCVD Patients With Hypercholesterolemia, ASCVD-risk Equivalent Patients With Hypercholesterolemia and Familial HypercholesterolemiaCompletedNCT06507852
• A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.CompletedNCT06431763Phase 4
• A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed DyslipidemiaCompletedNCT06386419Phase 4
• Specified Drug-use Survey of Leqvio for s.c. Injection.Active, not recruitingNCT06275724
• In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular DiseaseCompletedNCT05974345
• A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.Active, not recruitingNCT05739383Phase 3
• Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVDActive, not recruitingNCT05399992
• A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world SettingCompletedNCT05362903
• Study to Assess the Real World Effectiveness of Inclisiran in Chinese Adult Patients With Primary Hypercholesterolemia or Mixed DyslipidemiaCompletedNCT05118230
• Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular DiseaseActive, not recruitingNCT05030428Phase 3
• Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C)Active, not recruitingNCT04765657Phase 3
• Safety, Tolerability, PK and PD of LGT209 in Healthy Volunteers and Patients With HypercholesterolemiaCompletedNCT01979601Phase 1
• Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With StatinsCompletedNCT01859455Phase 1
• Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic PatientsCompletedNCT01487460Phase 1
• Efficacy and Safety of Valsartan and the Combination of Valsartan and SimvastatinCompletedNCT00385931Phase 3
• A Study to Evaluate the Efficacy of Valsartan/Simvastatin Combinations in Patients With Both Essential Hypertension and HypercholesterolemiaCompletedNCT00254475Phase 3
• A 10-12 Week Study to Evaluate the Safety and Efficacy of 320 mg Valsartan and 80 mg Simvastatin in Combination and as Monotherapies in Treating Hypertension and HypercholesterolemiaCompletedNCT00171093Phase 3
• Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary HypercholesterolemiaCompletedNCT00136799Phase 3