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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)

Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia

First Posted Date
2025-03-05
Last Posted Date
2025-03-05
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
2382
Registration Number
NCT06858332

Evolocumab in Patients with Multivessel Coronary Disease After Acute Myocardial Infarction: a Target Trial Emulation

Active, not recruiting
Conditions
Multivessel Coronary Artery Disease
Acute Myocardial Infarction (AMI)
Interventions
Drug: Lipid Lowering Medication
First Posted Date
2024-12-18
Last Posted Date
2024-12-20
Lead Sponsor
Shanghai Zhongshan Hospital
Target Recruit Count
912
Registration Number
NCT06740552
Locations
🇨🇳

Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China

YN001-004 in Patients With Coronary Atherosclerosis in Australia

Phase 2
Recruiting
Conditions
Coronary Artery Disease
Coronary Atherosclerotic Disease
Interventions
Drug: Dose 1 YN001
Drug: Dose 2 YN001
First Posted Date
2024-11-22
Last Posted Date
2025-04-30
Lead Sponsor
Beijing Inno Medicine Co., Ltd.
Target Recruit Count
12
Registration Number
NCT06700720
Locations
🇦🇺

Canberra Hospital, Canberra, Australian Capital Territory, Australia

🇦🇺

Albury Wodonga Private Hospital, Albury, New South Wales, Australia

🇦🇺

Core Research Group Pty Ltd, Milton, Queesland, Australia

and more 2 locations

Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction

Not Applicable
Recruiting
Conditions
STEMI
Interventions
Procedure: standard post-treatment for STEMI
First Posted Date
2024-04-15
Last Posted Date
2024-05-22
Lead Sponsor
Beijing Luhe Hospital
Target Recruit Count
84
Registration Number
NCT06364124
Locations
🇨🇳

Beijing luhe hospital, Beijing, China

A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)

Phase 2
Active, not recruiting
Conditions
Metastatic Renal Cell Carcinoma
Interventions
First Posted Date
2024-02-29
Last Posted Date
2025-03-07
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
10
Registration Number
NCT06284564
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

Expression of Pro- and Anti-inflammatory Cytokines During Anti-PCSK9 in Familial Hypercholesterolemia

Phase 4
Completed
Conditions
Hypercholesterolemia, Familial
Interventions
First Posted Date
2024-01-30
Last Posted Date
2024-01-30
Lead Sponsor
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Target Recruit Count
20
Registration Number
NCT06231459
Locations
🇲🇽

National Medical Center "20 de Noviembre", ISSSTE, Mexico City, Mexico

Short-term Effect of PCSK9 Inhibitor in Patients With Acute Ischemic Stroke

Not yet recruiting
Conditions
Acute Ischemic Stroke
Interventions
Drug: Statins
First Posted Date
2023-11-18
Last Posted Date
2023-11-18
Lead Sponsor
Xuanwu Hospital, Beijing
Target Recruit Count
80
Registration Number
NCT06134635

Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism

Early Phase 1
Not yet recruiting
Conditions
Acute Metabolic Effects of Evolocumab and Atorvastatin
Interventions
First Posted Date
2023-11-18
Last Posted Date
2023-11-18
Lead Sponsor
Region Stockholm
Target Recruit Count
8
Registration Number
NCT06140095

Mechanistic Clinical Trial of PCSK9 Inhibition for AAA

Early Phase 1
Not yet recruiting
Conditions
Abdominal Aortic Aneurysm
Interventions
Drug: Placebo
First Posted Date
2023-10-13
Last Posted Date
2024-12-11
Lead Sponsor
University of Pennsylvania
Target Recruit Count
44
Registration Number
NCT06081153

Evolocumab in STEMI

Phase 3
Recruiting
Conditions
ST Elevation Myocardial Infarction
Interventions
First Posted Date
2023-10-13
Last Posted Date
2023-10-13
Lead Sponsor
Sejong General Hospital
Target Recruit Count
166
Registration Number
NCT06081803
Locations
🇰🇷

Sejong General Hospital, Bucheon, Korea, Republic of

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