Clinical trials: PCSK9
Hypercholesterolemia, LDL Cholesterol
Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins
This study is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of LGT209 in hypercholesterolemic patients taking common statin medications and in healthy volunteers.
- Trial name
- NCT01859455
- Testing
- LGT209 50 mg, LGT209 300 mg, Statins (atorvastatin or simvastatin)
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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
Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection
Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia
The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM)…
- Trial name
- NCT02833844
- Testing
- Evolocumab
- Where
- 78 sites in United States, Australia and 13 more
- Volunteers
- 467 people
- Sponsor
- Amgen
Coronary Vessel, Coronary Circulation
Vascular Effects of Alirocumab in Acute MI-Patients
Coronary artery disease (CAD) is the most frequent cause of mortality in the industrialized world. Hypercholesterolemia is a major risk factor for the development and progression of CAD.
- Conditions
- Coronary Vessel, Coronary Circulation, Atheroma; Myocardial
- Trial name
- PACMAN-AMI (NCT03067844)
- Testing
- Alirocumab
- Where
- 9 sites in Austria, Denmark and 2 more
- Volunteers
- 294 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Peripheral Arterial Disease
A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease
Peripheral arterial disease (PAD) is characterized by lower limb arterial obstruction due to atherosclerosis. Magnetic resonance imaging (MRI) methods can accurately quantify atherosclerotic plaque in the superficial femoral…
- Trial name
- NCT02959047
- Testing
- Alirocumab
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of Virginia
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
Dyslipidemia
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).
- Trial name
- FOURIER OLE (NCT02867813)
- Testing
- Evolocumab
- Where
- 198 sites in United States, Czechia and 5 more
- Volunteers
- 5,035 people
- Sponsor
- Amgen
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
Acute Ischemic Stroke
PCSK9 Inhibitors in Acute Ischemic Stroke Patients Undergoing Endovascular Therapy
This is a prospective, multicenter, randomized controlled clinical study to evaluate the efficacy of PCSK9 inhibitor in addition to standard therapy in patients with acute ischemic stroke undergoing endovascular therapy.
- Trial name
- PCSK9-PROVE (NCT07174375)
- Testing
- PCSK9 inhibitor
- Where
- 12 sites in China
- Volunteers
- 478 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Sepsis
Alirocumab in Patients with Sepsis
The purpose of this study is to determine whether the drug alirocumab, which may lower cholesterol, can reduce the amount of inflammation caused by an infection that has caused either low blood pressure or difficulty breathing.
- Trial name
- PALMS (NCT05469347)
- Testing
- Alirocumab
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Jonathan Sevransky
Dyslipidemia, High Risk Coronary Artery Disease
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With High Risk Coronary Artery Disease (FORWARD)
The primary objective was to evaluate the effect of treatment with evolocumab on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever…
- Trial name
- FORWARD (NCT04087915)
- Testing
- Evolocumab
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Beijing Anzhen Hospital
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
Primary Aldosteronism
Comparing Inclisiran Versus Statin for Primary Aldosteronism
Primary aldosteronism represents one of the leading causes of resistant hypertension. Circulating cholesterol is established as the exclusive substrate for adrenal aldosterone synthesis, and statins, which suppress cholesterol…
- Trial name
- NCT07884955
- Testing
- inclisiran, Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin), Spironolactone (drug)
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Third Military Medical University
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
Lipoprotein Metabolism, PCSK9
Comparison of EPA and DHA-Rich Fish Oils on Lipoprotein Metabolism In Adults
Background: Metabolism is what the body does to turn food into energy. Omega-3 fatty acids are substances found in foods such as cold-water fish and shellfish that are essential for good health.
- Conditions
- Lipoprotein Metabolism, PCSK9, Proteomics
- Trial name
- NCT02514070
- Testing
- EPA-rich fish oil, DHA-rich fish oil
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
V-INTERVENTION will evaluate the effectiveness of inclisiran in preventing major cardiovascular and limb events in patients receiving percutaneous coronary or peripheral arterial revascularization.
- Trial name
- V-INTERVENTION (NCT06909565)
- Testing
- Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
- Where
- 147 sites in United States
- Volunteers
- 6,000 people
- Sponsor
- Duke University
Primary Prevention of Atherosclerotic Cardiovascular Disease
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at…
- Trial name
- NCT05739383
- Testing
- Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
- Where
- 983 sites in United States, Argentina and 40 more
- Volunteers
- 14,012 people
- Sponsor
- Novartis Pharmaceuticals