Clinical trial NCT03615534: Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females
Official title: Efficacy and Safety of Extended Release Niacin-Fenofibrate Combination and Monotherapy for the Treatment of Atherogenic Dyslipidemia in Obese Females
Conditions: Atherogenic Dyslipidemia
Obesity Associated Disorder
Summary: Atherogenic Dyslipidemia (AD) is a risk-conferring lipid/lipoprotein profile that comprises a higher proportion of small LDL particles, reduced HDL-C, and increased triglycerides. It is characteristically seen in patients with obesity, metabolic syndrome, insulin resistance, and type 2 diabetes mellitus and has emerged as an important marker for the increased cardiovascular disease (CVD) risk observed in these populations.
Optimal cardiovascular risk reduction in patients exhibiting the lipid triad of AD requires integrated pharmacotherapy to normalize HDL-C, Triglyceride (TG) and LDL-C levels. Recent studies have focused on optimizing treatment for AD and compare the efficacy and tolerability of combined lipid-altering drug based therapies, however, an optimal pharmacologic approach has not yet been established.
The present study was intended to evaluate the restorative efficacy of Extended Release Niacin (ER Niacin) and Fenofibrate as mono and combination therapies , as well as their safety and tolerability in females with obesity-induced AD.
Interventions:
description: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
name: Therapeutic Lifestyle Changes
type: Other
name: Placebo
type: Other
name: Fenofibrate
other_name: Lipanthyl
type: Drug
name: Wax Matrix Extended Release Niacin (WMER Niacin)
other_name: ENDUR-ACIN®
type: Dietary Supplement
Study arms:
design_group_description: Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.
design_group_title: Fenofibrate Monotherapy
design_group_type: Active Comparator
design_group_description: Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
design_group_title: WMER Niacin Monotherapy
design_group_type: Active Comparator
design_group_description: Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.
design_group_title: Combination Therapy
design_group_type: Active Comparator
Sponsor: Al-Kindy College of Medicine
Collaborators: Al-Kindy College of Medicine
Drug name mappings:
name: 非诺贝特
lang: CN
name: Fenofibrate
lang: EN
name: フェノフィブラート
lang: JP