Research Study: R1500 HTG 20118

Condition:
Other
Study Sponsor:
Regeneron Pharmaceuticals
Study Investigator:
Thomas Knickelbine, MD
Study Contact:

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 determine the proportion of patients with elevated triglycerides (TG), without familial chylomicronemia syndrome (FCS) due to loss of function (LoF) mutations in lipoprotein lipase (LPL), and a history of hypertriglyceridemia (HTG)-associated acute pancreatitis (AP) who experience a recurrent episode of AP after treatment with evinacumab versus placebo.

Eligibility Criteria:

  • Adults age 18-80 without FCS due to LPL loss of function mutations
  • Documented history of 1 HTG-associated AP episode within 24 months of screening
  • Fasting serum TG value >880 mg/dL (10 mmol/L) or >500 mg/dL (5.6mmol/L) determined during the screening period as described in the protocol
  • Stable dose of lipid-lowering therapy (≥8 weeks) and willingness to maintain a stable regimen throughout the study
  • Body mass index ≥18.0 and ≤45.0 kg/m2
  • Compliance with a stable diet and exercise regimen at screening and willingness to continue the diet through the end of the study
     

Get More Information At ClinicalTrials.gov