This study is designed to provide an assessment of the change in baseline lipid parameters with RVX000222 after 12 weeks and 24 weeks of treatment when given in addition to optimized statin background therapy in subjects with low baseline HDL-C.
One-third of the US population, almost 80 million adults, have cardiovascular disease and mortality associated with heart disease still remains as a leading cause of death around the world. The major risk factors for cardiovascular disease associated with atherosclerosis is dyslipidemia, characterized by high levels of low density lipoprotein (LDL) and/or low levels of high density lipoprotein (HDL). The widespread use of statins in patients at risk for cardiovascular disease has led to lower LDL levels but has had little effect on HDL levels. HDL has a well established role in atherosclerosis and cardiovascular disease protection. HDL mediates the removal of cholesterol from the atherosclerotic plaques for elimination from the body. The major component of HDL consists of apolipoprotein A-I (ApoA I). Recent intervention studies with synthetic HDL particles and recombinant ApoA-I have shown that HDL has the capacity to reverse coronary atherosclerosis. Increasing ApoA-I is likely to have a favorable effect on atherosclerotic plaque stability and size and on cardiovascular diseases. RVX000222 is a member of a novel class of small molecules that are candidates for the treatment of dyslipidemia by increasing plasma levels of HDL through increased ApoA-I transcription.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
176
capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 24 weeks
capsule, administer with food, twice daily 10-12 hrs apart, 24 weeks
Unnamed facility
East Burger Street, Bloemfontein, South Africa
Unnamed facility
Westdene, Bloemfontein, South Africa
The percent change in HDL-C from baseline to 24 weeks for RVX000222 200 mg daily compared to placebo
To determine whether treatment with RVX000222 produces an increase in HDL-C at 24 weeks compared to placebo.
Time frame: 24 weeks
Within treatment group percent change in HDL-C from baseline to 24 weeks for RVX000222 and placebo groups.
To evaluate changes in other lipids such as HDL-C, LDL-C, non-HDL-C, apoB, TG and HDL subclasses over time within and between treatment groups.
Time frame: 24 weeks
The percent change in plasma apoA-I from baseline to 4 weeks, 12 weeks and 24 weeks for RVX000222 compared to placebo (within and between treatment groups).
To evaluate changes in plasma levels of apoA-I over time within and between treatment groups.
Time frame: 4, 12 and 24 weeks
The percent change in LDL-C, non-HDL-C, apoB, TG and HDL subclasses from baseline to 4 weeks, 12 weeks and 24 weeks for RVX000222 compared to placebo (within and between treatment groups)
To evaluate changes in other lipids such as HDL-C, LDL-C, non-HDL-C, apoB, TG and HDL subclasses over time within and between treatment groups.
Time frame: 4, 12 and 24 weeks
Incidence of adverse events by treatment group
To evaluate the safety and tolerability of RVX000222.
Time frame: Participants will be followed for the duration of the study: 30 weeks (2 weeks screening, 24 weeks active treatment, 4 week follow-up)
The percent change in HDL-C from baseline to 4 weeks and 12 weeks for RVX000222 compared to placebo (within and between treatment groups)
To evaluate changes in other lipids such as HDL-C, LDL-C, non-HDL-C, apoB, TG and HDL subclasses over time within and between treatment groups.
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Unnamed facility
Goodwood, Cape Town, South Africa
Unnamed facility
Kraaifontein, Cape Town, South Africa
Unnamed facility
Pinelands, Cape Town, South Africa
Unnamed facility
Chatsworth, Durban, South Africa
Unnamed facility
KwaKhangela, Durban, South Africa
Unnamed facility
Merebank, Durban, South Africa
Unnamed facility
Sydenham, Durban, South Africa
Unnamed facility
Tongaat, Durban, South Africa
...and 15 more locations
Time frame: 4, 12 weeks
The percent change in hsCRP from baseline to 12 weeks and 24 weeks for RVX000222 compared to placebo (within and between treatment groups).
To evaluate changes in hs-CRP over time within and between treatment groups.
Time frame: 12, 24 weeks