Overview

Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis

Status:
Recruiting
Trial end date:
2024-10-22
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to determine the proportion of patients with triglycerides (TG) >880 mg/dL, 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. The secondary objectives of the study are: - To determine the change in the standard lipid profile after therapy with evinacumab versus placebo - To determine the changes in specialty lipoprotein parameters (ApoC3, ApoB48, ApoB100, and nuclear magnetic resonance [NMR] lipid profile) after therapy with evinacumab versus placebo - To measure the number of AP episodes per patient - To assess the safety and tolerability of evinacumab - To assess the potential immunogenicity of evinacumab - To assess the concentrations of total evinacumab and total angiopoietin-like 3 (ANGPTL3)
Phase:
Phase 2
Details
Lead Sponsor:
Regeneron Pharmaceuticals