Type II Hyperlipidemia Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of DRL-17822 in Patients With Type II Hyperlipidemia
The purpose of this study is to determine if a new drug, DRL-17822, is safe and effective in elevating high density lipoprotein cholesterol (HDL-C) and reducing low density lipoprotein cholesterol (LDL-C) in people with abnormal cholesterol levels that may put them at risk for heart disease.
Cardiovascular disease is a leading cause of death worldwide. Among cardiovascular
disorders, coronary heart disease (CHD) caused by atherosclerosis is the most common cause
of morbidity and mortality. Prevention, stabilization and regression of atherosclerotic
plaques may have a major impact on reducing the risk of acute coronary events.
LDL-C lowering agents, primarily the statins, are the current mainstay in the pharmacologic
management of dyslipidemia. However even with stain use, residual CHD risk from dyslipidemia
remains. Epidemiologic and observational studies have shown that HDL-C is also a strong
independent predictor of CHD, suggesting that raising HDL-C levels might afford clinical
benefit in the reduction of cardiovascular risk.
Presently only niacin is approved by the FDA for HDL-C elevation and can raise HDL-C levels
by 20-30%. However its use can be limited by a high incidence of flushing and, less
commonly, by elevation of blood glucose and potential hepatic toxicity.
Cholesteryl ester transfer protein (CETP) inhibitors are being explored for their ability to
elevate HDL-C. A small molecule CETP inhibitor, torcetrapib, has been demonstrated to
elevate HDL-C by 60-100%. However, a large clinical trial (ILLUMINATE) where it increased
HDL-C by a mean of 72% compared to baseline was halted as it failed to show benefit.
Post-hoc analysis of this study implicated an off-target increase in blood pressure as
potentially counteracting any anti-atherosclerotic benefits. Post-hoc subgroup analysis
showed that patients in the highest HDL-C quartile had a 57% reduction in the risk of
cardiovascular events.
Increased blood pressure appears to be specifically related to torcetrapib as two other
small molecule CETP inhibitors, anacetrapib and dalcetrapib, have not shown this in clinical
trials and have been well tolerated. DRL-17822 has also not shown elevation of blood
pressure in either animals or in normal volunteers.
This study will investigate the efficacy and tolerability of DRL-17822 as dyslipidemia
monotherapy in patients with Type II hyperlipidemia.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00688896 -
Efficacy and Safety Study of JTT-705 in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia
|
Phase 2 |