Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis
Public ClinicalTrials.gov record NCT04863014. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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)
Study identification
- NCT ID
- NCT04863014
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 21 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 12, 2021 (Actual)
- Primary completion
- Feb 15, 2023 (Actual)
- Completion
- Feb 15, 2023 (Actual)
- Last update posted
- May 22, 2024
2021 – 2023
United States locations
- U.S. sites
- 32
- U.S. states
- 20
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Radin Cardivascular Medical Group, Inc | Newport Beach | California | 92663 | — |
| Yale Cancer Center - Yale University | New Haven | Connecticut | 06510 | — |
| Excel Medical Clinical Trials, LLC | Boca Raton | Florida | 33434 | — |
| Harmony Medical Research Institute, Inc. | Hialeah | Florida | 33015 | — |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | — |
| NorthShore Medical Group | Evanston | Illinois | 60201 | — |
| Advocate Medical Group Midwest Heart Specialists | Park Ridge | Illinois | 60068 | — |
| Methodist Medical Center of Illiniois - UnityPoint Clinic | Peoria | Illinois | 61636 | — |
| Quincy Medical Group | Quincy | Illinois | 62301 | — |
| St. Vincent Medical Group, Inc. | Carmel | Indiana | 46290 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | — |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | — |
| University of Minnesota | Minneapolis | Minnesota | 55422 | — |
| Saint Louis University | St Louis | Missouri | 63110 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Northwell Health | Manhasset | New York | 11030 | — |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Mt Sinai - Ichan Medical Institute | New York | New York | 10029 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati Hospital | Cincinnati | Ohio | 45267 | — |
| Penn Medicine: University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| University Of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| University Diabetes & Endocrine Consultants | Chattanooga | Tennessee | 37411 | — |
| Methodist Dallas Medical Center | Dallas | Texas | 75208 | — |
| Sante Clinical Research | Kerrville | Texas | 78028 | — |
| University of Washington | Seattle | Washington | 98109 | — |
| MultiCare Institute for Research | Spokane | Washington | 99202 | — |
| West Virginia University Heart & Vascular Institute | Morgantown | West Virginia | 26506 | — |
| Wisconsin Center for Advanced Research - a division of GI Associates, LLC | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04863014, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 22, 2024 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04863014 live on ClinicalTrials.gov.