Clinical trials: PCSK9 Inhibitor
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
Colon Cancer, PCSK9 Inhibitor
Tafolecimab Combined With Chemoimmunotherapy as Neoadjuvant Treatment for pMMR/MSS Locally Advanced Colon Cancer
This multicenter, randomized, open-label, blinded-endpoint Phase II trial assesses the efficacy and safety of tolecizumab (PCSK9 inhibitor) plus sintilimab/CapeOX chemoimmunotherapy as neoadjuvant treatment for pMMR/MSS locally…
- Conditions
- Colon Cancer, PCSK9 Inhibitor, Neoadjuvant Immunochemotherapy
- Trial name
- TRIUNITE-08 (NCT07840677)
- Testing
- Tafolecimab, Sintilimab
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Hypercholesterolemia
Multiple Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Chinese Patients With Hypercholesterolemia
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R…
- Trial name
- NCT03815812
- Testing
- IBI306
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Hypercholesterolemia, Familial Hypercholesterolemia
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with hypercholesterolemia.
- Trial name
- NCT05952856
- Testing
- Enlicitide Decanoate
- Where
- 168 sites in United States, Argentina and 12 more
- Volunteers
- 2,912 people
- Sponsor
- Merck Sharp & Dohme LLC
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)
The research team is conducting a randomized, double-blind, placebo-controlled, multicenter clinical study aimed at evaluating the impact of adding Tolecilimab (a PCSK9 inhibitor) to standard lipid-lowering therapy (statins ±…
- Trial name
- NCT07341958
- Testing
- Tafolecimab
- Where
- China
- Volunteers
- 242 people
- Sponsor
- Beijing Tiantan Hospital
Cardiovascular Risk Factor, Cardiovascular Diseases
Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction
This study is to assess LDL-C reductions at Week 52 with monthly (Q4W [≤31 days]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with CVD, or at high risk for CVD, on a…
- Conditions
- Cardiovascular Risk Factor, Cardiovascular Diseases, Cardiovascular Stroke, Hypercholesterolemia
- Trial name
- LIBerate-HR (NCT04806893)
- Testing
- lerodalcibep
- Where
- 6 sites in United States, India and 1 more
- Volunteers
- 900 people
- Sponsor
- LIB Therapeutics LLC
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
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy
The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9 inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL cholesterol.
- Trial name
- NCT03193047
- Testing
- bempedoic acid 180mg, evolocumab
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Esperion Therapeutics, Inc.
Efficacy and Safety, Heterozygous Familial Hypercholesterolemia
Application of PCSK9 Inhibitors in Patients With Heterozygous Familial Hypercholesterolemia
This study plans to enroll several patients with heterozygous familial hypercholesterolemia, randomly assigned to different dose groups, and randomly receiving subcutaneous injection of IBI306150 mg or placebo every two weeks: or…
- Conditions
- Efficacy and Safety, Heterozygous Familial Hypercholesterolemia, PCSK9
- Trial name
- NCT04759534
- Testing
- protein convertase subtilisin/kexin type 9 inhibitor
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Shenzhen People's Hospital
Arteriosclerosis, Hypercholesterolaemia
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes
This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of enlicitide decanoate, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk.
- Trial name
- NCT06008756
- Testing
- Enlicitide Decanoate
- Where
- 669 sites in United States, Argentina and 27 more
- Volunteers
- 14,550 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia, Familial Hypercholesterolemia
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial hypercholesterolemia.
- Trial name
- NCT05952869
- Testing
- Enlicitide Decanoate
- Where
- 59 sites in United States, Australia and 15 more
- Volunteers
- 303 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia
A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.
This study is a phase IV, open-label, randomized study designed to evaluate the efficacy of Inclisiran vs. bempedoic acid (BPA) in 400 adult subjects (≥ 18 years) at very high and high risk for cardiovascular events as defined by…
- Trial name
- NCT06431763
- Testing
- Inclisiran sodium, BPA
- Where
- 55 sites in Germany
- Volunteers
- 402 people
- Sponsor
- Novartis Pharmaceuticals
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
Heterozygous Familial Hypercholesterolemia (HeFH)
Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial Hypercholesterolemia
The goal is to assess the long term efficacy (LDL cholesterol reduction) and safety over 3 years of lerodalcibep (Lerochol) SC 300 mg QM administered by auto-injector (AI)/pre-filled pen (PFP) in male and female pediatric…
- Trial name
- NCT07775339
- Testing
- Lerodalcibep
- Where
- 5 sites in India, Israel and 3 more
- Volunteers
- 150 people
- Sponsor
- LIB Therapeutics LLC
Hypercholesterolemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in…
- Trial name
- GAUSS-4 (NCT02634580)
- Testing
- Evolocumab, Ezetimibe
- Where
- 35 sites in Japan
- Volunteers
- 61 people
- Sponsor
- Amgen
Myocardial Ischaemic Syndrome, Coronary Heart Disease
Protective Effect of PCSK9 Inhibitor Against Negative Inflammatory Response and Organ Dysfunction After Coronary Artery Bypass Grafting (PANDA VIII)
This is a multi-center, randomized controlled study to investigate whether early offering PCSK9 inhibitor can protect against negative inflammatory response and organ dysfunction after coronary artery bypass grafting (CABG).
- Trial name
- PANDA (NCT06730802)
- Testing
- PCSK9 inhibitor, Statin
- Where
- 2 sites in China
- Volunteers
- 400 people
- Sponsor
- Nanjing Medical University
Hypercholesterolaemia
A Study of PCSK9 Inhibitor AK102 in Healthy Subjects
This is a first-in-human,randomized, double-blind, placebo-controlled, single dose escalation, phase 1 study to evaluate the safety, tolerability, PK/PD and immunogenicity of AK102 administered subcutaneously in healthy subjects.
- Trial name
- NCT04169386
- Testing
- AK102
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Akeso
Early PCSK9 Inhibitor on Ventricular Remodling
Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction
This is a prospect, multi-center, random study to investigate whether early offering PCSK9 inhibitor to acute myocardium infarction(AMI) can alleviate ventricular remodeling after primary percutaneous intervention(PPCI).
- Trial name
- PERFECT-AMI (NCT04731155)
- Testing
- PCSK9 inhibitor （Alirocumab）plus standard medications, standard medications
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- Shanghai Tong Ren Hospital
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with…
- Trial name
- GAUSS (NCT01375764)
- Testing
- Evolocumab, Ezetimibe
- Where
- 42 sites in United States, Australia and 6 more
- Volunteers
- 160 people
- Sponsor
- Amgen
Primary Hypercholesterolemia
DNV001 Injection in Patients With Hypercholesterolemia
This is a Phase II clinical study to evaluate the effectiveness and safety of different doses of DNV001 injection in patients with primary hypercholesterolemia or mixed dyslipidemia who have not achieved adequate control of…
- Trial name
- DNV001 (NCT07391722)
- Testing
- DNV001 Injection
- Volunteers
- 120 people
- Sponsor
- Hangzhou Dinovate Biotech Co., Ltd