Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia

Conditions Phase Intervention Type
2
Drug
Evinacumab
Matching placebo
Other
Background Lipid Modifying Therapy (LMT)

Eligibility

Ages Eligible for Study
18 years to 80 years
Genders Eligible for Study
Both

Keywords

Sponsors

Industry
Regeneron Pharmaceuticals

Inclusion Criteria

1. Men and women, ages 18 through 80 at the screening visit

2. Diagnosis of primary hypercholesterolemia, either HeFH or non-HeFH with clinical ASCVD

3. A history of clinical ASCVD, for those patients who are non-HeFH.

4. Receiving a stable maximally tolerated statin (± ezetimibe) for at least 4 weeks at
screening

5. For those patients with HeFH who are not receiving a statin at screening,
documentation of inability to tolerate at least 2 statins.

6. Receiving alirocumab 150 mg SC Q2W, OR evolocumab 140 mg SC Q2W or 420 mg SC Q4W for
at least 8 weeks prior to the screening visit

7. For those patients with a history of clinical ASCVD, serum LDL-C ≥ 70 mg/dL at
screening (1 repeat lab is allowed)

8. For those patients without a history of clinical ASCVD, serum LDL-C ≥ 100 mg/dL at
screening (1 repeat lab is allowed)

9. Provide signed informed consent

Key

Exclusion Criteria

1. Known history of homozygous FH (clinically, or by previous genotyping)

2. Presence of any clinically significant uncontrolled endocrine disease known to
influence serum lipids or lipoproteins

3. Newly diagnosed diabetes (within 3 months prior to screening)

4. Use of thyroid medications (except for replacement therapy which has been stable for
at least 12 weeks before screening)

5. Laboratory findings during screening period (not including randomization labs):

1. Triglycerides > 400 mg/dL (> 4.52 mmol/L) for patients without a known history of
diabetes mellitus; OR Triglycerides > 300 mg/dL (> 3.39 mmol/L) for patients with
a known history of diabetes mellitus

2. Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody
(associated with a positive HCV ribonucleic acid [RNA] polymerase chain reaction)

3. Positive serum beta-human chorionic gonadotropin or urine pregnancy test in women
of childbearing potential

4. Estimated glomerular filtration rate < 30 mL/min/1.73 m^2

5. TSH > 1.5 x ULN

6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x ULN

6. Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening
visit or time of randomization

7. History of heart failure (New York Heart Association [NYHA] Class III-IV) within 12
months before screening

8. History of MI, unstable angina leading to hospitalization, CABG surgery, PCI,
uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, TIA, carotid
revascularization, endovascular procedure or surgical intervention for peripheral
vascular disease within 3 months prior screening

9. History of cancer within the past 5 years (except for adequately treated basal cell
skin cancer, squamous cell skin cancer, or in situ cervical cancer)

10. Having received LDL apheresis within 2 months before screening

11. Pregnant or breast-feeding women

12. Women of childbearing potential who are unwilling to practice a highly effective birth
control method

13. Sexually active men unwilling to use acceptable birth control.

Detailed Description

The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite receiving maximally-tolerated LMT. Persistent hypercholesterolemia is defined as LDL-C ≥70 mg/dL (1.81 mmol/L) for those patients with clinical ASCVD and LDL-C ≥100 mg/dL (2.59 mmol/L) for those patients without clinical ASCVD.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03175367

Locations

  • Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
    Newcastle Upon Tyne, United Kingdom

    Status: Active, not recruiting

  • Royal Free Hospital-Royal Free London NHS Foundation Trust
    London, United Kingdom

    Status: Active, not recruiting

  • Karolinska University Hospital
    Malmö, Sweden

    Status: Active, not recruiting

  • Hospital Universitario A Coruna
    A Coruña, A Coruna Spain

    Status: Recruiting

  • Slaskie Centrum Chorob Serca, III Katedra i Oddzial Kliniczny Kardiologii SUM- Oddzial Chorob Serca i Naczyn
    Zabrze, Poland

    Status: Active, not recruiting

  • Wojewodzki Szpital Specjalistyczny
    Bytom, Poland

    Status: Recruiting

See 70 more locations

Overall Contact Backup

Clinical Trials Administrator
844-734-6643