Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Hypertriglyceridemia
In brief
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. 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)
Key facts
- Study ID
- NCT04863014
- Run by
- Regeneron Pharmaceuticals
- People needed
- 21
- Starts
- 2021-07-12
- Expected to finish
- 2023-02-15
- Last updated by the study team
- 2024-05-22
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Radin Cardivascular Medical Group, Inc — Newport Beach, California, United States
- Yale Cancer Center - Yale University — New Haven, Connecticut, United States
- Excel Medical Clinical Trials, LLC — Boca Raton, Florida, United States
- Harmony Medical Research Institute, Inc. — Hialeah, Florida, United States
- Northeast Georgia Medical Center — Gainesville, Georgia, United States
- NorthShore Medical Group — Evanston, Illinois, United States
- Advocate Medical Group Midwest Heart Specialists — Park Ridge, Illinois, United States
- Methodist Medical Center of Illiniois - UnityPoint Clinic — Peoria, Illinois, United States
- Quincy Medical Group — Quincy, Illinois, United States
- St. Vincent Medical Group, Inc. — Carmel, Indiana, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
- Minneapolis Heart Institute — Minneapolis, Minnesota, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Saint Louis University — St Louis, Missouri, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Northwell Health — Manhasset, New York, United States
- NYU Langone Hospital - Long Island — Mineola, New York, United States
- Weill Cornell Medical College — New York, New York, United States
- Mt Sinai - Ichan Medical Institute — New York, New York, United States
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
- University of Cincinnati Hospital — Cincinnati, Ohio, United States
- Penn Medicine: University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
- University Of Pittsburgh — Pittsburgh, Pennsylvania, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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