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

Phase 4

• Conditions: Familial Dysbetalipoproteinemia; Hyperlipoproteinemia Type III
• Interventions: Drug: Placebos; Drug: Evolocumab Auto-Injector [Repatha]

• Registration Number: NCT03811223
• Lead Sponsor: UMC Utrecht

Brief 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.

Detailed Description

See brief summary

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-17
• Last Update Submitted: 2019-01-17
• Study First Posted: 2019-01-22
• Last Update Posted: 2019-01-22
• Study Start: 2019-08
• Primary Completion: 2021-01
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Placebo injection once every 2 weeks for 12 weeks
Evolocumab	Evolocumab Auto-Injector [Repatha]	Evolocumab 140 mg subcutaneous injection once every 2 weeks for 12 weeks

Primary Outcome Measures

Name	Time	Method
AUC (area under the curve) non-HDL-cholesterol	12 weeks

Secondary Outcome Measures

Name	Time	Method
Fasting and post fat load lipoprotein (VLDL1, VLDL2, IDL, LDL, HDL) concentrations and composition (triglycerides, cholesterol, ApoB and apolipoproteins).	12 weeks
Post fat load ApoB 48-containing lipoprotein concentrations (chylomicrons and chylomicron remnants) and proteins involved in postprandial lipid metabolism.	12 weeks
Fasting levels, AUC and iAUC of total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides and ApoB, as well as fasting non-HDL-cholesterol.	12 weeks
Percentage change from baseline and absolute difference in fasting and post fat load non-HDL-cholesterol, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides and ApoB.	12 weeks