NCT03811223

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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Trial to Evaluate the Effects of Evolocumab Added to Standard Lipid-lowering Therapy on Fasting and Post Fat Load Lipids in Patients With Familial Dysbetalipoproteinemia

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Familial Dysbetalipoproteinemia
• Hyperlipoproteinemia Type III

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-01-01
• Completion: 2021-03-01
• First posted: 2019-01-22
• Last updated: 2019-01-22