Clinical trials: PCSK9 Inhibitor
Acute Coronary Syndromes
Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients(ELITE-ACS)
The purpose of this clinical trial is to evaluate the impact of early initiation of PCSK9 inhibitor therapy for intensive lipid-lowering in Chinese patients with acute coronary syndrome (ACS) during hospitalization on the rate of…
- Trial name
- ELITE-ACS (NCT06738758)
- Testing
- PCSK9 inhibitor, Statin+Ezetimibe/Hybutimibe compound, Statin
- Where
- China
- Volunteers
- 6,000 people
- Sponsor
- Yun Dai Chen
Moderate Renal Impairment
A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007)
This study evaluated the safety, tolerability and pharmacokinetic (PK) effects of enlicitide chloride in participants with moderate renal impairment (RI) to those of healthy matched control participants.
- Trial name
- NCT05070390
- Testing
- Enlicitide Chloride
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
ASCVD, Atherosclerotic Cardiovascular Disease
Study on the Composite Endpoint Event of PCSK9 Inhibitor in Patients With Very High Risk of ASCVD and Cancer
This study is a prospective, randomized, open-label, and single center trial. To evaluate the effect of treatment with PCSK9 inhibitor on the risk for cardiovascular death, recurrent unstable angina, myocardial infarction…
- Conditions
- ASCVD, Atherosclerotic Cardiovascular Disease, Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor, Cancer
- Trial name
- NCT05976893
- Testing
- Evolocumab, Statin
- Volunteers
- 620 people
- Sponsor
- Xiang Xie
Intracranial Atherosclerosis, Acute Ischemic Stroke
Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with alirocumab results in greater change from baseline in intracranial atherosclerotic plaque at week 26 than control in adults with acute ischemic stroke…
- Conditions
- Intracranial Atherosclerosis, Acute Ischemic Stroke, ICAS - Intracranial Atherosclerosis
- Trial name
- TOPICAL-MRI (NCT05001984)
- Testing
- Alirocumab
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- Chang Gung Memorial Hospital
Atherosclerosis, Cardiovascular Diseases
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
The INTENSITY-LOW study aims to answer if there are any limits to LDL reduction in relation to benefitting vascular health from a mechanistic viewpoint, and therefore potentially limitations to primary prevention in healthy…
- Trial name
- NCT03273972
- Testing
- Written Informed Consent, Inclusion/Exclusion check, Full Clinical Chemistry and Haematology Bloods
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol…
- Trial name
- GAUSS-2 (NCT01763905)
- Testing
- Evolocumab, Ezetimibe
- Where
- 58 sites in United States, Australia and 12 more
- Volunteers
- 307 people
- Sponsor
- Amgen
NSCLC (Advanced Non-small Cell Lung Cancer), Resistance to Immunotherapy
PD-1 Combined With Bevacizumab and PCSK-9 Inhibitor in Patients With Advanced NSCLC Who Have Progressed After Anti- PD- 1/L1 Therapy
This study evaluated the sintilimab combination of bevacizumab and tafolecimab in NSCLC patients who have previously been treated with anti- PD- 1/ligand (L)1 and acquired resistance.
- Trial name
- NCT07014215
- Testing
- Sintilimab combined with Bevacizumab and tafolecimab
- Volunteers
- 52 people
- Sponsor
- Anhui Provincial Cancer Hospital
Coronary Disease
In-hospital Initiation of PCSK9 Inhibitor in Patients With Acute Myocardial Infarction
Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been shown to improve cardiovascular outcomes when added to conventional statin therapy.
- Trial name
- NCT05184530
- Testing
- Evolocumab 140 MG/ML
- Volunteers
- 7,556 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Hypercholesterolemia
A Study of PCSK9 Inhibitor AK102 in Patients With Hypercholesterolemia
This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with Hypercholesterolemia Patients at Very High or High Risk of Cardiovascular Disease .
- Trial name
- NCT04358432
- Testing
- AK102, Statins and/or Ezetimibe
- Where
- 2 sites in China
- Volunteers
- 262 people
- Sponsor
- Akeso
Non-small Cell Lung Cancer (NSCLC)
PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung
PCSK9 mediates immune checkpoint blockade resistance by downregulating tumor cell surface MHC class 1 molecules. This study will evaluate if combining the anti-PCSK9 antibody alirocumab with the anti-PD-1 antibody cemiplimab can…
- Trial name
- NCT05553834
- Testing
- Alirocumab and Cemiplimab
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Duke University
Hypercholesterolemia, Atherosclerotic Ischemic Disease
Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients
Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy
- Trial name
- LIBerate-VI (NCT05004675)
- Testing
- lerodalcibep, Inclisiran
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 166 people
- Sponsor
- LIB Therapeutics LLC
Hypercholesterolemia and Mixed Dyslipidemia
A Phase II Study to Evaluate the Safety and Efficacy of SAL003 Combined With Atorvastatin in Hypercholesterolemia and Mixed Dyslipidemia
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of SAL003, a recombinant fully human anti-PCSK9 monoclonal antibody, in combination with a stable…
- Trial name
- NCT07278830
- Testing
- SAL003 140mg+Atorvastatin, SAL003 420mg+Atorvastatin
- Where
- China
- Volunteers
- 214 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Acute Coronary Syndrome
Low-dose PCSK9 Inhibitor Combined With Stains on Serum Lipids in Chinese Population With Acute Coronary Syndrome
A total of 100 patients aged 18-85 years old with a definite diagnosis of ACS were admitted to the Department of Cardiovascular, The First Affiliated Hospital of Nanjing Medical University.
- Trial name
- NCT05298475
- Testing
- Statin, PCSK9 inhibitor
- Where
- China
- Volunteers
- 100 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Hypercholesterolemia, Familial Hypercholesterolemia
A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)
The purpose of this study is to evaluate the efficacy and safety of enclitide chloride, an oral PCSK9 inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia.
- Trial name
- NCT05261126
- Testing
- Enclitide Chloride
- Where
- 63 sites in United States, Germany and 6 more
- Volunteers
- 381 people
- Sponsor
- Merck Sharp & Dohme LLC
Homozygous Familial Hypercholesterolemia
A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH
AK102 is being developed for the treatment of HoFH. The study will be conducted in 2 parts, part 1 is open label, single arm study to evaluate the safety, tolerability and efficacy of PCSK9 inhibitor AK102, and part 2 is double…
- Trial name
- NCT03933293
- Testing
- AK102, Statins, Ezetimibe
- Where
- 2 sites in China
- Volunteers
- 10 people
- Sponsor
- Akeso
Carotid Artery Stenosis
A Cohort Study Comparing PCSK9 Inhibitor Plus Statin With Statin Monotherapy for Carotid Artery Stenosis
A multicenter cohort study
- Trial name
- TRIP-CAS (NCT07036991)
- Testing
- PCSK9 inhibitor (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe, Rosuvastatin/Atorvastatin ± Ezetimibe
- Where
- China
- Volunteers
- 406 people
- Sponsor
- Changhai Hospital
Acute Ischemic Stroke
Efficacy and Safety of PCSK9 Inhibitors in Patients With Large-Artery Atherosclerosis (LAA) Ischemic Stroke
This prospective multicenter cohort study aims to evaluate the effectiveness and safety of early PCSK9 inhibitor therapy in patients with large-artery atherosclerotic ischemic stroke.
- Trial name
- NCT07540741
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- First Affiliated Hospital of Harbin Medical University
Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With ACS Undergoing PCI
Investigators aimed to evaluate efficacy and safety of early Initiation of evolocumab and combination lipid-lowering agent (statin + Ezetimibe) on lipid profiles changes in patients with ACS undergoing PCI
- Trial name
- C-STAR (NCT05661552)
- Testing
- Evolocumab 140 MG/ML, Rosuvastatin 5mg, Ezetimibe 10mg
- Where
- South Korea
- Volunteers
- 108 people
- Sponsor
- Yonsei University
Atherosclerosis Cerebral, Carotid Plaque
RESCUE: PCSK9 Inhibitors for Carotid Vulnerable Plaque Remodeling
Carotid artery stenosis is a major cause of ischemic stroke. However, many strokes occur in patients with only mild-to-moderate stenosis.
- Conditions
- Atherosclerosis Cerebral, Carotid Plaque, Vulnerable Plaque, Carotid Stenosis
- Trial name
- RESCUE (NCT07819643)
- Testing
- Intervention 1, Intervention 3, Intervention 2
- Volunteers
- 120 people
- Sponsor
- Keqiang Zhao
Sepsis, Septic Shock
Treatment of Severe Infection With Antihyperlipidemia Drug
Proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors increase LDL receptors by decreasing its degradation. In sepsis the pathogenic substances, endotoxin, lipoteichoic acid, phospholipomannan are the main cause of the…
- Trial name
- NCT03634293
- Testing
- Alirocumab Injectable Product, Saline Solution
- Where
- Israel
- Volunteers
- 712 people
- Sponsor
- Wolfson Medical Center