drugset / Trial / NCT03811223
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
Unknown
30 enrolled
UMC Utrecht
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · collabErasmus Medical Center · collabUniversity Medical Center Nijmegen · collab
RandomizedCrossoverQuadruple-blindTreatment
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.
Timeline
- Start
- 2019-08
- Primary completion
- 2021-01
- Completion
- 2021-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Evolocumab | Monoclonal antibody | 140 mg | Subcutaneous |