Clinical trials: PCSK9
Hypertension, Dyslipidemias
Exploring the Effects of Antihypertensive and Lipid-Lowering Drugs on Inflammatory Cytokine Levels
This study investigates the causal relationships between antihypertensive and lipid-lowering drugs and inflammatory cytokines using a drug-targeted Mendelian randomization approach.
- Conditions
- Hypertension, Dyslipidemias, Inflammatory Response, Chronic Inflammation
- Trial name
- MRDLT (NCT06622304)
- Where
- China
- Volunteers
- 250,736 people
- Sponsor
- Guangzhou Institute of Respiratory Disease
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
Hypercholesterolemia, Mixed Dyslipidemia
A Study to Assess the Real-World Effectiveness of Inclisiran and PCSK9 mAbs in Chinese Hypercholesterolemia Adult Patients
The purpose of this study was to describe the effectiveness of inclisiran and proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in the real-world setting in China.
- Trial name
- NCT07409636
- Where
- United States
- Volunteers
- 11,991 people
- Sponsor
- Novartis Pharmaceuticals
Abdominal Aortic Aneurysm
Mechanistic Clinical Trial of PCSK9 Inhibition for AAA
The goal of this mechanistic clinical trial is to assess whether lowering the low-density lipoprotein cholesterol (LDL-C) levels in the blood with the injections of the medication evolocumab will have any effect on the tissue or…
- Trial name
- NCT06081153
- Testing
- Evolocumab
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- University of Pennsylvania
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
Safety, Tolerability, PK and PD of LGT209 in Healthy Volunteers and Patients With Hypercholesterolemia
This study is designed to measure the effects of LGT209 when given intravenously to patients with high cholesterol who are on stable doses of statin medications, and to healthy subjects with elevated cholesterol
- Trial name
- NCT01979601
- Testing
- LGT209
- Where
- 2 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Dyslipidemias
Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With ACS
The study is prospective, open-label, randomized, single-center study involving patients admitted on an emergency basis with an acute coronary syndrome (ACS) clinic who underwent PCI of an infarct-related artery (IRA) and had…
- Trial name
- Combi-LLT ACS (NCT05624658)
- Testing
- Combined Lipid-lowering Therapy
- Where
- Russia
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Samara Regional Cardiology Dispensary
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
Acute Metabolic Effects of Evolocumab and Atorvastatin
Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism
Eight healthy male volunteers will be studied in consecutive sessions regarding the acute effect of evolocumab and atorvastatin on cholesterol and bile metabolism.
- Trial name
- NCT06140095
- Testing
- Evolocumab
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Region Stockholm
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
Hypercholesterolemia
Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment
To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.
- Trial name
- NCT02585895
- Testing
- Evolocumab, Low-density Lipoprotein Cholesterol (LDL-C) Apheresis
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 39 people
- Sponsor
- Amgen
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
Hyperlipidemias
A Study of SAL003 in Participants With Hypercholesterolemia and Mixed Dyslipidemia
This is a Phase 3 study to evaluate the efficacy and safety of SAL003, a fully human monoclonal antibody against PCSK9, as monotherapy in Chinese participants with hypercholesterolemia and mixed dyslipidemia.
- Trial name
- NCT07295418
- Testing
- SAL003 140 mg
- Where
- China
- Volunteers
- 618 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
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
Sepsis
Evolocumab for PCSK9 Lowering in Early Acute Sepsis (The PLEASe Study)
This study evaluates using evolocumab, a currently approved and marketed biologic drug, in a novel way. Patients who present to the emergency room or intensive care unit (ICU) with severe infection are eligible.
- Trial name
- PLEASe (NCT03869073)
- Testing
- Evolocumab
- Where
- 3 sites in Canada
- Volunteers
- 36 people
- Sponsor
- University of British Columbia
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
Hyperlipidemias, Hypercholesterolemia, Mixed Dyslipidemia
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of SAL003 in Combination With Statin Therapy in Patients With Hypercholesterolemia and Mixed Dyslipidemia
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Recombinant Fully Human Anti-PCSK9 Monoclonal Antibody Injection (SAL003) in Combination with Statin…
- Trial name
- NCT07253584
- Testing
- SAL003 140 mg
- Where
- China
- Volunteers
- 720 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.