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Evolocumab

Generic Name
Evolocumab
Brand Names
Repatha
Drug Type
Biotech
Chemical Formula
-
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)
Associated Therapies
-

Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia

Phase 3
Completed
Conditions
Hypercholesterolemia
Interventions
First Posted Date
2018-02-12
Last Posted Date
2018-02-12
Lead Sponsor
Hospital General Universitario Gregorio Marañon
Target Recruit Count
9
Registration Number
NCT03429998
Locations
🇪🇸

Hospital General Universitario Gregorio Marañon, Madrid, Spain

Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia

Phase 4
Completed
Conditions
Homozygous Familial Hypercholesterolemia HoFH
Interventions
First Posted Date
2018-01-18
Last Posted Date
2024-05-29
Lead Sponsor
Amgen
Target Recruit Count
30
Registration Number
NCT03403374
Locations
🇮🇳

Research Site, Lucknow, Uttar Pradesh, India

A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

First Posted Date
2017-11-09
Last Posted Date
2024-12-24
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
314
Registration Number
NCT03337698
Locations
🇨🇳

Taipei Veterans General Hospital, Taipei City, Taiwan

🇪🇸

Hospital Clinico Universitario de Valencia, Valencia, Spain

🇨🇳

National Cheng Kung University Hospital; Gasterointestinal, Tainan City, Taiwan

and more 33 locations

Impact of LDL-cholesterol Lowering on Platelet Activation

Phase 4
Terminated
Conditions
Familial Hypercholesterolemia
Interventions
First Posted Date
2017-11-06
Last Posted Date
2021-04-01
Lead Sponsor
Columbia University
Target Recruit Count
4
Registration Number
NCT03331666
Locations
🇺🇸

Columbia University Medical Center, New York, New York, United States

Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus

Phase 4
Terminated
Conditions
Diabetes Mellitus, Type 2
Percutaneous Coronary Intervention
Dyslipidemia Associated With Type II Diabetes Mellitus
Interventions
Drug: Evolocumab
Drug: Placebo
First Posted Date
2017-08-23
Last Posted Date
2023-01-19
Lead Sponsor
Inova Health Care Services
Target Recruit Count
4
Registration Number
NCT03258281
Locations
🇺🇸

Inova Fairfax Hospital, Falls Church, Virginia, United States

Antiplatelet Effects of Evolocumab in Patients With Peripheral Arterial Disease

Terminated
Conditions
Peripheral Arterial Disease
Interventions
First Posted Date
2017-08-14
Last Posted Date
2024-02-16
Lead Sponsor
Inova Health Care Services
Target Recruit Count
30
Registration Number
NCT03247972
Locations
🇺🇸

Inova Fairfax Hospital, Falls Church, Virginia, United States

Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy

Phase 2
Completed
Conditions
Hypercholesterolemia
Interventions
Drug: bempedoic acid 180mg
Other: placebo
Drug: evolocumab
First Posted Date
2017-06-20
Last Posted Date
2020-04-03
Lead Sponsor
Esperion Therapeutics, Inc.
Target Recruit Count
59
Registration Number
NCT03193047
Locations
🇺🇸

L-MARC Research Center, Louisville, Kentucky, United States

Impact of Evolocumab on the Effects of Clopidogrel in Patients With High On-Treatment Platelet Reactivity

Phase 4
Completed
Conditions
Atherosclerotic Cardiovascular Disease
Interventions
Other: Placebo
Drug: Evolocumab
First Posted Date
2017-03-30
Last Posted Date
2022-02-17
Lead Sponsor
University of Florida
Target Recruit Count
259
Registration Number
NCT03096288
Locations
🇺🇸

University of Florida, Jacksonville, Florida, United States

Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries

Phase 3
Terminated
Conditions
Dyslipidemia
Interventions
First Posted Date
2017-03-15
Last Posted Date
2024-05-29
Lead Sponsor
Amgen
Target Recruit Count
1600
Registration Number
NCT03080935
Locations
🇧🇪

Centre Hospitalier Universitaire Brugmann, Brussels, Belgium

🇧🇪

Algemeen Ziekenhuis Sint Lucas, Gent, Belgium

🇧🇪

Imelda Ziekenhuis vzw, Bonheiden, Belgium

and more 82 locations

An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol

Phase 2
Completed
Conditions
Atherosclerotic Cardiovascular Disease
Symptomatic Atherosclerosis
Type2 Diabetes
Familial Hypercholesterolemia
Interventions
First Posted Date
2017-02-23
Last Posted Date
2023-03-24
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
382
Registration Number
NCT03060577
Locations
🇬🇧

Novartis Investigative Site, Worcester, United Kingdom

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