Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis
NCT ID: NCT04863014
Last Updated: 2024-05-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
21 participants
INTERVENTIONAL
2021-07-12
2023-02-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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)
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis Pain
NCT01001923
Gemcitabine With or Without CI-994 in Treating Patients With Advanced Pancreatic Cancer
NCT00004861
Everolimus in Patients With Pancreatic Neuroendocrine Tumors Metastatic to the Liver Previously Treated With Surgery
NCT02031536
A Study With LY293111, Gemcitabine and Placebo in Patients With Pancreatic Cancer
NCT00055250
A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain
NCT01159119
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
evinacumab
Randomized 1:1
evinacumab
Intravenous infusion every 4 weeks (Q4W)
Placebo
Randomized 1:1
Placebo
Intravenous infusion Q4W
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
evinacumab
Intravenous infusion every 4 weeks (Q4W)
Placebo
Intravenous infusion Q4W
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Documented history of 1 HTG-associated AP episode within 24 months of screening
3. 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
4. Stable dose of lipid-lowering therapy (≥8 weeks) and willingness to maintain a stable regimen throughout the study
5. Body mass index ≥18.0 and ≤45.0 kg/m2
6. Compliance with a stable diet and exercise regimen at screening and willingness to continue the diet through the end of the study
Exclusion Criteria
2. Known genetic FCS defined as homozygous or compound heterozygous LoF mutations in LPL as defined in the protocol
3. Symptomatic gallstone disease within 6 months prior to screening as defined in the protocol
4. Use of any medication or nutraceutical known to alter serum lipids which has not been part of a stable therapeutic regimen for at least 8 weeks, and there are no plans to change the regimen during the study
5. Presence of any clinically significant, uncontrolled endocrine disease known to influence serum lipids as defined in the protocol
6. Has received a COVID-19 vaccination within 1-week of planned start medication or for which the planned COVID-19 vaccination would not be completed 1-week prior to start of the study
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, United States
Methodist Dallas Medical Center
Dallas, Texas, United States
Sante Clinical Research
Kerrville, Texas, United States
University of Washington
Seattle, Washington, United States
MultiCare Institute for Research
Spokane, Washington, United States
West Virginia University Heart & Vascular Institute
Morgantown, West Virginia, United States
Wisconsin Center for Advanced Research - a division of GI Associates, LLC
Milwaukee, Wisconsin, United States
Robarts Research Institute
London, Ontario, Canada
Centre Etudes Cliniques Ecogene-21
Chicoutimi, Quebec, Canada
Clinique des maladies lipidiques de Quebec
Québec, , Canada
University Hospital Carl Gustav Carus
Dresden, , Germany
University Hospital of Leipzig
Leipzig, , Germany
Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)
Amsterdam, , Netherlands
Ziekenhuis Rijnstate
Arnhem, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-000437-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R1500-HTG-20118
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.