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Trial record 3 of 74 for:    Recruiting, Not yet recruiting, Available Studies | "Hypercholesterolemia"

Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia

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ClinicalTrials.gov Identifier: NCT03175367
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Evinacumab Drug: Matching placebo Other: Background Lipid Modifying Therapy (LMT) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients With Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : April 6, 2020
Estimated Study Completion Date : September 14, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A: dosing regimen 1
SC Evinacumab QW for 16 weeks
Drug: Evinacumab
SC or IV administration
Other Name: REGN1500

Other: Background Lipid Modifying Therapy (LMT)
All participants should be on a stable, maximally tolerated statin throughout the duration of the study. The dose of statin and of PCSK9 inhibitor, such as alirocumab or evolocumab, as well as other LMT (if applicable), should remain stable throughout the study duration, from screening through the end of study (EOS) visit.

Experimental: Group A: dosing regimen 2
SC Evinacumab Q2W for 16 weeks (alternating with matching placebo on opposite weeks)
Drug: Evinacumab
SC or IV administration
Other Name: REGN1500

Other: Background Lipid Modifying Therapy (LMT)
All participants should be on a stable, maximally tolerated statin throughout the duration of the study. The dose of statin and of PCSK9 inhibitor, such as alirocumab or evolocumab, as well as other LMT (if applicable), should remain stable throughout the study duration, from screening through the end of study (EOS) visit.

Experimental: Group A: dosing regimen 3
SC Evinacumab QW for 16 weeks
Drug: Evinacumab
SC or IV administration
Other Name: REGN1500

Other: Background Lipid Modifying Therapy (LMT)
All participants should be on a stable, maximally tolerated statin throughout the duration of the study. The dose of statin and of PCSK9 inhibitor, such as alirocumab or evolocumab, as well as other LMT (if applicable), should remain stable throughout the study duration, from screening through the end of study (EOS) visit.

Experimental: Group A: matching placebo
Placebo SC QW for 16 weeks
Drug: Matching placebo
SC or IV administration

Other: Background Lipid Modifying Therapy (LMT)
All participants should be on a stable, maximally tolerated statin throughout the duration of the study. The dose of statin and of PCSK9 inhibitor, such as alirocumab or evolocumab, as well as other LMT (if applicable), should remain stable throughout the study duration, from screening through the end of study (EOS) visit.

Experimental: Group B: dosing regimen 1
Intravenous (IV) Evinacumab Q4W for 24 weeks
Drug: Evinacumab
SC or IV administration
Other Name: REGN1500

Other: Background Lipid Modifying Therapy (LMT)
All participants should be on a stable, maximally tolerated statin throughout the duration of the study. The dose of statin and of PCSK9 inhibitor, such as alirocumab or evolocumab, as well as other LMT (if applicable), should remain stable throughout the study duration, from screening through the end of study (EOS) visit.

Experimental: Group B: dosing regimen 2
IV Evinacumab Q4W for 24 weeks
Drug: Evinacumab
SC or IV administration
Other Name: REGN1500

Other: Background Lipid Modifying Therapy (LMT)
All participants should be on a stable, maximally tolerated statin throughout the duration of the study. The dose of statin and of PCSK9 inhibitor, such as alirocumab or evolocumab, as well as other LMT (if applicable), should remain stable throughout the study duration, from screening through the end of study (EOS) visit.

Experimental: Group B: matching placebo
Placebo IV Q4W for 24 weeks
Drug: Matching placebo
SC or IV administration

Other: Background Lipid Modifying Therapy (LMT)
All participants should be on a stable, maximally tolerated statin throughout the duration of the study. The dose of statin and of PCSK9 inhibitor, such as alirocumab or evolocumab, as well as other LMT (if applicable), should remain stable throughout the study duration, from screening through the end of study (EOS) visit.




Primary Outcome Measures :
  1. Percent change in calculated low-density lipoprotein cholesterol (LDL-C) from baseline to week 16 in the intent-to-treat (ITT) population. [ Time Frame: Baseline to Week 16 ]

Secondary Outcome Measures :
  1. Percent change in Apolipoprotein B (ApoB) from baseline to week 16 [ Time Frame: Baseline to Week 16 ]
  2. Percent change in non high-density lipoprotein cholesterol (HDL-C) from baseline to week 16 [ Time Frame: Baseline to Week 16 ]
  3. Percent change in total cholesterol (TC) from baseline to week 16 [ Time Frame: Baseline to Week 16 ]
  4. Proportion of patients with ≥ 30% reduction in calculated LDL-C at week 16 [ Time Frame: Baseline to Week 16 ]
  5. Proportion of patients with ≥ 50% reduction in calculated LDL-C at week 16 [ Time Frame: Baseline to Week 16 ]
  6. Percent change in triglycerides (TGs) from baseline to week 16 [ Time Frame: Baseline to Week 16 ]
  7. Percent change in Lipoprotein(a) [(Lp(a)] from baseline to week 16 [ Time Frame: Baseline to Week 16 ]
  8. Proportion of patients with calculated LDL-C < 100 mg/dL (2.59 mmol/L) at week 16 [ Time Frame: Baseline and at Week 16 ]
  9. Proportion of patients with calculated LDL-C < 70 mg/dL (1.81 mmol/L) at week 16 [ Time Frame: Baseline and at Week 16 ]
  10. Proportion of patients with calculated LDL-C < 50 mg/dL (1.81 mmol/L) at week 16 [ Time Frame: Baseline and at Week 16 ]
  11. Percent change in calculated LDL-C from baseline to week 24 [ Time Frame: Baseline to Week 24 ]
    (only applicable to those participants receiving IV route of study treatment administration)

  12. Percent change in calculated ApoB from baseline to week 24 [ Time Frame: Baseline to Week 24 ]
    (only applicable to those participants receiving IV route of study treatment administration)

  13. Percent change in calculated non-HDL-C from baseline to week 24 [ Time Frame: Baseline to Week 24 ]
    (only applicable to those participants receiving IV route of study treatment administration)

  14. Percent change in calculated TC from baseline to week 24 [ Time Frame: Baseline to Week 24 ]
    (only applicable to those participants receiving IV route of study treatment administration)

  15. Percent change in calculated TG from baseline to week 24 [ Time Frame: Baseline to Week 24 ]
    (only applicable to those participants receiving IV route of study treatment administration)

  16. Percent change in calculated Lp(a) from baseline to week 24 [ Time Frame: Baseline to Week 24 ]
    (only applicable to those participants receiving IV route of study treatment administration)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

The inclusion/ exclusion criteria below, include, but are not limited to, the following:

Key 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175367


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

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Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03175367     History of Changes
Other Study ID Numbers: R1500-CL-1643
2017-001508-31 ( EudraCT Number )
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs