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: -

Clinical Trials

Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

Phase 3

Active, not recruiting

Conditions: Coronary Heart Disease (CHD)

Interventions: Drug: Placebo
Drug: Evolocumab

First Posted Date: 2019-03-13

Last Posted Date: 2024-11-18

Lead Sponsor: Amgen

Target Recruit Count: 12301

Registration Number: NCT03872401

Locations: 🇺🇸
Nature Coast Clinical Research LLC, Crystal River, Florida, United States
🇺🇸
Multicare Institute for Research and Innovation, Puyallup, Washington, United States
🇦🇺
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

and more 839 locations

Evolocumab for PCSK9 Lowering in Early Acute Sepsis (The PLEASe Study)

Phase 2

Conditions: Sepsis

Interventions: Drug: Evolocumab
Drug: Placebo

First Posted Date: 2019-03-11

Last Posted Date: 2020-03-03

Lead Sponsor: University of British Columbia

Target Recruit Count: 36

Registration Number: NCT03869073

Locations: 🇨🇦
Surrey Memorial Hospital, Surrey, British Columbia, Canada
🇨🇦
Vancouver General Hospital, Vancouver, British Columbia, Canada
🇨🇦
St. Paul's Hospital, Vancouver, British Columbia, Canada

The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular Disease

Phase 4

Completed

Conditions: Atherosclerotic Vascular Disease
Type2 Diabetes
Microvascular Dysfunction

Interventions: Drug: Placebo
Drug: Evolocumab

First Posted Date: 2019-02-04

Last Posted Date: 2023-03-08

Lead Sponsor: Robert Rosenson

Target Recruit Count: 41

Registration Number: NCT03829046

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
🇨🇦
St. Michael's - University of Toronto, Toronto, Ontario, Canada

EVOlocumab in Stable Heart Failure With Reduced Ejection Fraction of Ischemic Etiology: EVO-HF Pilot

Phase 2

Completed

Conditions: Heart Failure With Reduced Ejection Fraction

Interventions: Drug: Evolocumab

First Posted Date: 2019-01-02

Last Posted Date: 2023-02-15

Lead Sponsor: Fundació Institut Germans Trias i Pujol

Target Recruit Count: 46

Registration Number: NCT03791593

Locations: 🇪🇸
Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
🇪🇸
Hospital Universitario Virgen del Rocío, Sevilla, Spain
🇪🇸
Hospital Clínico de Valencia, Valencia, Spain

Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients

Phase 3

Completed

Conditions: Cardiac Allograft Vasculopathy

Interventions: Drug: Placebo
Drug: Evolocumab

First Posted Date: 2018-11-07

Last Posted Date: 2023-11-01

Lead Sponsor: Lars Gullestad

Target Recruit Count: 130

Registration Number: NCT03734211

Locations: 🇩🇰
Department of Cardiology, Aarhus University Hospital, Skejby, Denmark
🇫🇮
Helsinki University Hospital Heart and Lung Center, Helsinki, Finland
🇩🇰
Department of Cardiology, Rigshospitalet, Copenhagen, Denmark

and more 2 locations

Effect of Evolocumab on Coronary Atherosclerosis

Phase 3

Completed

Conditions: Cardiovascular Disease
Hyperlipidemia

Interventions: Drug: Evolocumab
Diagnostic Test: 18F-NaF PET
Diagnostic Test: CCTA
Drug: Omnipaque
Drug: Metoprolol
Drug: Nitroglycerin

First Posted Date: 2018-10-01

Last Posted Date: 2024-07-17

Lead Sponsor: Cedars-Sinai Medical Center

Target Recruit Count: 55

Registration Number: NCT03689946

Locations: 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States

Imaging of Coronary Plaques in Participants Treated With Evolocumab

Phase 3

Completed

Conditions: Coronary Artery Disease (CAD)

Interventions: Drug: Placebo
Drug: Evolocumab
Drug: Statin therapy

First Posted Date: 2018-06-27

Last Posted Date: 2022-05-03

Lead Sponsor: Amgen

Target Recruit Count: 164

Registration Number: NCT03570697

Locations: 🇺🇸
University of California at Los Angeles, Los Angeles, California, United States
🇦🇺
Royal Adelaide Hospital, Adelaide, South Australia, Australia
🇭🇺
Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, Hungary

and more 30 locations

Evolocumab in Acute Coronary Syndrome

Phase 2

Completed

Conditions: Acute Coronary Syndrome

Interventions: Drug: Placebo
Drug: Evolocumab

First Posted Date: 2018-05-03

Last Posted Date: 2024-11-15

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 60

Registration Number: NCT03515304

Locations: 🇺🇸
Steven Paul Schulman, Baltimore, Maryland, United States

Effect of Evolocumab on Coronary Endothelial Function

Phase 2

Completed

Conditions: Human Immunodeficiency Virus
Coronary Artery Disease

Interventions: Drug: Evolocumab

First Posted Date: 2018-04-18

Last Posted Date: 2020-07-24

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 19

Registration Number: NCT03500302

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia

Phase 3

Terminated

Conditions: Primary Hypercholesterolemia
Mixed Dyslipidemia

Interventions: Drug: placebo
Drug: evolocumab

First Posted Date: 2018-02-15

Last Posted Date: 2023-03-27

Lead Sponsor: Amgen

Target Recruit Count: 259

Registration Number: NCT03433755

Locations: 🇨🇳
Sun Yat-sen Memorial Hospital Sun Yat-sen University, Guangzhou, Guangdong, China
🇨🇳
The Third Xiangya Hospital of Central South University, Changsha, Hunan, China
🇨🇳
Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, China

and more 28 locations

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