MedPath

Evolocumab

Generic Name
Evolocumab
Brand Names
Repatha
Drug Type
Biotech
CAS Number
1256937-27-5
Unique Ingredient Identifier
LKC0U3A8NJ
Background

Evolocumab is a monoclonal antibody designed for the treatment of hyperlipidemia by Amgen. It is a subcutaneous injection approved by the FDA for individuals on maximum statin therapy who still require additional LDL-cholesterol lowering. It is approved for both homozygous and heterozygous familial cholesterolemia as an adjunct to other first-line therapies. Evolocumab is a human IgG2 monoclonal antibody that targets the proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that targets LDL receptors for degradation, therefore reducing the liver's ability to remove LDL-cholesterol (LDL-C), or "bad" cholesterol, from the blood. Evolocumab is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface, resulting in more LDL receptors on the surface of the liver to remove LDL-C from the blood. Evolocumab is the second PCSK9 inhibitor on the market, first being alirocumab.

Indication

Evolocumab is indicated in adult patients with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization. It is also indicated as an adjunct to diet, alone or in combination with other hypolipidemic treatments, in adults with primary hyperlipidemia (and in pediatric patients ≥10 years old with heterozygous familial hypercholesterolemia) to reduce LDL-C. In addition, it is indicated adjunctly to other hypolipidemic treatments in patients ≥10 years old with homozygous familiar hypercholesterolemia to reduce LDL-C.

Associated Conditions
Coronary Revascularization, Myocardial Infarction, Stroke, Increases in serum total low-density lipoprotein (LDL)

Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19

Phase 3
Completed
Conditions
Sars-CoV-2 Infection
Interventions
Drug: Saline solution
First Posted Date
2021-06-28
Last Posted Date
2023-04-21
Lead Sponsor
Collegium Medicum w Bydgoszczy
Target Recruit Count
60
Registration Number
NCT04941105
Locations
🇵🇱

Antoni Jurasz University Hospital No. 1, Bydgoszcz, Poland

The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation

Early Phase 1
Completed
Conditions
Glioblastoma
Malignant Glioma
Interventions
First Posted Date
2021-06-24
Last Posted Date
2024-06-25
Lead Sponsor
Duke University
Target Recruit Count
32
Registration Number
NCT04937413
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

CARotid plaqUe StabilizatiOn and Regression With Evolocumab.

Phase 4
Conditions
Carotid Artery Disease
Interventions
Other: lipid-lowering therapy (LLT)
First Posted Date
2021-01-29
Last Posted Date
2021-07-28
Lead Sponsor
Azienda Ospedaliera Ordine Mauriziano di Torino
Target Recruit Count
130
Registration Number
NCT04730973
Locations
🇮🇹

Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Piedmont, Italy

Impact of Evolocumab as an Additional Lipid-lowering Therapy to Changes in Lipid Core Burden Index of Non-culprit Vulnerable Plaque in Patients Who Underwent Percutaneous Coronary Intervention for the Acute Coronary Syndrome

Phase 4
Recruiting
Conditions
Clinical Trial
Acute Coronary Syndrome
Interventions
Device: NIRS IVUS
First Posted Date
2021-01-22
Last Posted Date
2023-10-05
Lead Sponsor
Korea University Anam Hospital
Target Recruit Count
60
Registration Number
NCT04719221
Locations
🇰🇷

Korea University Anam Hospital, Seoul, Korea, Republic of

Effect of Evolocumab on Coronary Plaque Characteristics

Phase 4
Completed
Conditions
Coronary Artery Disease
Interventions
First Posted Date
2021-01-14
Last Posted Date
2023-11-18
Lead Sponsor
Annapoorna Kini
Target Recruit Count
137
Registration Number
NCT04710368
Locations
🇺🇸

Mount Sinai Hospital, New York, New York, United States

PCSK 9 Inhibition as Secondary Prevention in Renal Transplant Patients

Phase 3
Completed
Conditions
Kideny Transplant Recipients With High Cardiovascular Risk Score
Interventions
First Posted Date
2020-12-14
Last Posted Date
2020-12-14
Lead Sponsor
Hamid Al-Essa Organ Transplant Center
Target Recruit Count
200
Registration Number
NCT04665830
Locations
🇰🇼

OTC, MOH , Kuwait, Kuwait, Kuwait

Evolocumab Plus Ezetimibe in Haemodialized Statin-intolerant Patients With Hypercholesterolemia

Phase 4
Conditions
Hypercholesterolemia
CKD Stage 5
Chronic Kidney Disease Requiring Chronic Dialysis
Interventions
First Posted Date
2020-12-09
Last Posted Date
2020-12-17
Lead Sponsor
Policlinico Casilino ASL RMB
Target Recruit Count
50
Registration Number
NCT04659525
Locations
🇮🇹

Policlinico Casilino, Rome, Italy

Markers of Cardiovascular Risk in Patients With Premature Coronary Artery Disease and Treatment

Not Applicable
Conditions
Acute Coronary Syndrome
Premature Coronary Heart Disease
Lipoproteinemia
Inflammation
Genetic Polymorphisms
Interventions
First Posted Date
2020-11-03
Last Posted Date
2020-11-03
Lead Sponsor
University Medical Centre Ljubljana
Target Recruit Count
70
Registration Number
NCT04613167
Locations
🇸🇮

University Medical Centre Ljubljana-Department of Vascular diseases and dept. of Cardiology, Ljubljana, Slovenia

Lipid Management in Renal Transplant Recipients Using Evolocumab.

Phase 4
Recruiting
Conditions
Hyperlipidemias
Interventions
Drug: Statins (Cardiovascular Agents)
First Posted Date
2020-10-29
Last Posted Date
2023-07-27
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
120
Registration Number
NCT04608474
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

Reducing Intracranial atheroSclErosis With Repatha

Phase 4
Terminated
Conditions
Ischemic Stroke
Interventions
First Posted Date
2020-10-05
Last Posted Date
2023-03-15
Lead Sponsor
University of California, Los Angeles
Target Recruit Count
10
Registration Number
NCT04573777
Locations
🇺🇸

UCLA, Los Angeles, California, United States

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