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Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis

NCT04863014 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-05-22

Study results available
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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)

Conditions

  • Hypertriglyceridemia

Interventions

DRUG

evinacumab

Intravenous infusion every 4 weeks (Q4W)

OTHER

Placebo

Intravenous infusion Q4W

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2023-02-15
Completion
2023-02-15
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04863014 on ClinicalTrials.gov