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Effects of Evolocumab Versus Placebo Added to Standard Lipid-lowering Therapy on Fasting and Post Fat Load Lipids in Patients With Familial Dysbetalipoproteinemia

NCT03811223 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-01-22

No results posted yet for this study

Summary

Patients with familial dysbetalipoproteinemia (FD) have increased triglycerides, non-high-density lipoprotein cholesterol (non-HDL-C), beta VLDL, premature atherosclerosis and cardiovascular disease. They also have a delayed postprandial triglyceride and chylomicron (CM) remnant clearance. Postprandial hypertriglyceridemia is associated with increased vascular risk. Although combination therapy with statin and fibrate is recommended in the treatment of patients with FD, there is still a substantial amount of patient who do not reach their treatment target with this medication. Furthermore no information is available about the postprandial effects of adding evocolumab to standard lipid lowering therapy in FD patients.

Conditions

  • Familial Dysbetalipoproteinemia
  • Hyperlipoproteinemia Type III

Interventions

DRUG

Evolocumab Auto-Injector [Repatha]

Evolocumab 140 mg every 2 weeks for 12 weeks

DRUG

Placebos

Placebo subcutaneous injection every 2 weeks for 12 weeks

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • University Medical Center Nijmegen

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Frank LJ Visseren, prof · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-31
Primary Completion
2021-01-31
Completion
2021-03-31

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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 NCT03811223 on ClinicalTrials.gov