Research Study: R1500
Study Sponsor: Regeneron Pharmaceuticals
Study Investigator: Thomas Knickelbine, MD
Study Contact: Christine Majeski
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

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.
Eligibility Criteria:

  • Men and women, ages 18 through 80 at the screening visit
  • Diagnosis of primary hypercholesterolemia, either HeFH or non-HeFH with clinical ASCVD
  • A history of clinical ASCVD, for those patients who are non-HeFH.
  • Receiving a stable maximally tolerated statin (± ezetimibe) for at least 4 weeks at screening
  • For those patients with HeFH who are not receiving a statin at screening, documentation of inability to tolerate at least 2 statins.
  • 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
  • For those patients with a history of clinical ASCVD, serum LDL-C ≥ 70 mg/dL at screening (1 repeat lab is allowed)
  • For those patients without a history of clinical ASCVD, serum LDL-C ≥ 100 mg/dL at screening (1 repeat lab is allowed)
  • Provide signed informed consent

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!