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)

The Safety and Long-Term Clinical Benefit of PCSK9i in STEMI Patients

Phase 4
Not yet recruiting
Conditions
Dyslipidemias
STEMI
Interventions
First Posted Date
2022-10-13
Last Posted Date
2022-10-13
Lead Sponsor
Hamad Medical Corporation
Target Recruit Count
350
Registration Number
NCT05579418

Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy

Recruiting
Conditions
Hypercholesterolemia
Interventions
First Posted Date
2022-06-24
Last Posted Date
2023-09-28
Lead Sponsor
Federico II University
Target Recruit Count
2000
Registration Number
NCT05430828
Locations
🇮🇹

Ospedali dell'Ovest Vicentino, Arzignano, Italy

🇮🇹

University of Bari Aldo Moro, Bari, Italy

🇮🇹

Università degli Studi di Genova, Genova, Italy

and more 24 locations

Impact of Evolocumab on the Antiplatelet Effects of Ticagrelor and Aspirin in Patients With Acute Coronary Syndrome

Conditions
Acute Coronary Syndrome
Interventions
First Posted Date
2022-06-14
Last Posted Date
2022-06-14
Lead Sponsor
First Affiliated Hospital of Harbin Medical University
Target Recruit Count
30
Registration Number
NCT05418166
Locations
🇨🇳

the first affiliated hospital of Harbin Medical University, Harbin, Heilongjiang, China

EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

Phase 4
Active, not recruiting
Conditions
Coronary Revascularization
Cardiovascular Disease
Myocardial Infarction
Stroke
Interventions
Drug: Routine Lipid Management
First Posted Date
2022-03-17
Last Posted Date
2024-11-15
Lead Sponsor
Amgen
Target Recruit Count
6019
Registration Number
NCT05284747
Locations
🇺🇸

John Muir Health and Cardiovascular Institute, Concord, California, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Northern Arizona Healthcare Corporation Cardiovascular Institute, Flagstaff, Arizona, United States

and more 116 locations

In-hospital Initiation of PCSK9 Inhibitor in Patients With Acute Myocardial Infarction

Completed
Conditions
Coronary Disease
Interventions
First Posted Date
2022-01-11
Last Posted Date
2022-01-11
Lead Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Target Recruit Count
7556
Registration Number
NCT05184530

The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk

Phase 4
Recruiting
Conditions
Stable Coronary Disease
Interventions
First Posted Date
2021-12-10
Last Posted Date
2024-08-09
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
50
Registration Number
NCT05152888
Locations
🇺🇸

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

A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC

Phase 2
Active, not recruiting
Conditions
Lung Cancer Metastatic
Interventions
First Posted Date
2021-12-03
Last Posted Date
2025-04-17
Lead Sponsor
Scott Antonia
Target Recruit Count
38
Registration Number
NCT05144529
Locations
🇺🇸

Duke Univ. Medical Center, Durham, North Carolina, United States

PCSK9 Inhibitor on ACS Patients With Multivessel Disease and Relatively Low LDL-C Level in Chinese Population

Not Applicable
Conditions
Acute Coronary Syndrome
Interventions
First Posted Date
2021-09-14
Last Posted Date
2021-09-14
Lead Sponsor
Second Xiangya Hospital of Central South University
Target Recruit Count
1360
Registration Number
NCT05043740

A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease

Phase 2
Completed
Conditions
Atherosclerotic Cardiovascular Disease
Interventions
Drug: NNC0385-0434 A 15 mg
Other: Placebo I A (for NNC0385-0434 A 40 mg)
Other: Placebo I A (for NNC0385-0434 A 15 mg)
Drug: NNC0385-0434 A 40 mg
Drug: NNC0385-0434 A 100 mg
Other: Placebo II A (for NNC0385-0434 A 100 mg)
First Posted Date
2021-08-05
Last Posted Date
2024-02-16
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
255
Registration Number
NCT04992065
Locations
🇺🇸

Northwest Heart Clinical Research, LLC, Arlington Heights, Illinois, United States

🇳🇱

Deventer Ziekenhuis, Deventer, Netherlands

🇩🇪

MVZ CCB Frankfurt Und Main-Taunus GbR, Frankfurt, Germany

and more 41 locations

Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI

Phase 4
Recruiting
Conditions
STEMI - ST Elevation Myocardial Infarction
NSTEMI - Non-ST Segment Elevation MI
Interventions
Drug: Standard of care (SOC)
First Posted Date
2021-07-07
Last Posted Date
2025-01-28
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
2166
Registration Number
NCT04951856
Locations
🇫🇷

ACTION Group, Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC, Paris, France

© Copyright 2025. All Rights Reserved by MedPath