A new phase III clinical trial designed to explore whether the weight-loss drug Acomplia (rimonabant) can slow atherosclerosis, the fatty build-up in arteries that creates heart attack risk, was announced February 1 by researchers at the University of Rochester Medical Center.

Results of previous studies have shown that Acomplia reduces triglycerides and increases HDL “good” cholesterol, independent of weight loss.

The new study, titled STRADIVARIUS (Strategy to Reduce Atherosclerosis Development Involving Administration of Rimonabant-The Intravascular Ultrasound Study), will explore whether these effects may also impact the progression of atherosclerosis.

Dr. Frederick S. Ling, associate professor of Medicine at the University of Rochester Medical Center and lead investigator for STRADIVARIUS, said the trial will involve 800 patients worldwide, including 500 at a variety of medical centers around the United States, and has almost completed enrollment.

Patients qualify if there is a 20 percent, but less than 50 percent, stenosis in one of their coronary arteries (mild coronary artery disease). Stenosis is an abnormal narrowing in a blood vessel, an effect of damaging deposits within arterial walls.

Only patients with mild coronary artery disease are being included in STRADIVARIUS because those with an artery more than 50 percent closed may need treatment for the blockage, such as angioplasty (balloon or stent) or heart bypass surgery.

Participants in the trial will be randomized to receive either placebo or a 20 mg tablet of Acomplia daily for an 18-month period. The primary measure of success will be whether coronary artery disease progressed less in those on Acomplia during the trial period.

“Obesity, diabetes, high cholesterol and coronary artery disease have all reached epidemic proportions to become leading causes of death despite being largely preventable,” said Ling.

“These risk factors, called metabolic syndrome when combined in one person, feed off each other and are made much worse by smoking. New approaches are urgently needed, and our lab has the tools to measure accurately whether new treatments actually slow the progression of coronary artery disease," Ling added.