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NCT04863014 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis
A Phase 2 study, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT04863014 is a Phase 2 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 21 participants.
The verdict
NCT04863014, a Phase 2 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
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)
Interventions
- OTHER Placebo
- DRUG evinacumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-07-12 |
| Est. Completion | 2023-02-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04863014
The ClinicalTrials.gov registry entry for NCT04863014 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04863014 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04863014 about?
NCT04863014 is a clinical study titled "Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis". 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 pancreatit...
What is the current status of trial NCT04863014?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2021-07-12. Estimated completion is 2023-02-15.
What interventions are being tested in trial NCT04863014?
The interventions under investigation include: Placebo (OTHER), evinacumab (DRUG).
Who is sponsoring clinical trial NCT04863014?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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