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

Sponsor
UMC Utrecht
Study ID
NCT03811223
Phase
PHASE4
Status
Unknown

Conditions

  • Familial Dysbetalipoproteinemia
  • Hyperlipoproteinemia Type III

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 31, 2019
Status verified
Jan 2019
Primary completion
Jan 31, 2021
Completion
Mar 31, 2021

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Evolocumab
    Evolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks
  • Placebo Comparator: Placebo
    Placebo injection once every 2 weeks for 12 weeks

Primary Outcome Measure

AUC (area under the curve) non-HDL-cholesterol [ Time Frame: 12 weeks ]

Central Contacts