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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: Clinical Trial Phase 2 study, sponsored by Regeneron Pharmaceuticals.
NCT04863014 is a Phase 2 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
All AP (Acute Pancreatitis) episodes occurred post-study drug treatment.
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 |
Why NCT04863014 stopped before completion
NCT04863014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04863014 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04863014's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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