A new clinical trial of Acomplia (rimonabant) is expected to begin enrolling participants in the next few weeks at 125 research centers in the United States, Canada, Europe and Australia.

This trial will explore the value of Acomplia in helping prevent the development of coronary artery disease in obese and overweight people at high risk, according to Dr. Magdi Ghali, an interventional cardiologist at Iowa Heart Center in Des Moines.

The trial appears designed to further explore one of the most encouraging aspects of earlier Acomplia trials, which showed that it not only can help overweight individuals shed pounds but can also help improve a number of heart-disease risk factors collectively known as metabolic syndrome.

The major clinical trials of Acomplia held to date have focused on its role in weight-reduction and helping smokers break the habit.

Sanofi-Aventis, developer of the drug, also has indicated that data from a separate trial being conducted to determine the extent to which Acomplia may be able to help diabetics will be presented at the American Diabetes Association annual scientific meeting in San Diego in June.

The new trial of the value of Acomplia in preventing development of cornorary artery disease will run 18 to 24 months, according to Ghali, with participants being put on a mild hypocaloric diet and smokers receiving counseling.

Participants will have two ultrasound pictures taken of the coronary artery to see the amount of plaque buildup prior to and following treatment.

Half of the patients will receive 20 milligrams of rimonabant, and half will receive a placebo.

This is an interesting development, in that previous trials have also tested a 5 milligram dose of rimonabant. This loiwer dose was considerably less effective than the higher dose, and Sanofi now appears to be planning to drop the lower dose from its new trial.

A total of 800 patients are expected to be enrolled in the new study worldwide, according to Ghali.

The report in the Des Moines Register that the Iowa Heart Center would be one of the centers taking part in the study was the first word of this new clinical trial.

Ghali said participants in the trial would be selected from patients who have been told they need a coronary angiography, an X-ray of the blood vessels or heart, using a catheter.

He said researchers also were looking for participants who had a waist circumference greater than 35 inches for women and 40 inches for men.

Other criteria include at least one of three conditions.

• Currently smoking but willing to stop.
• A C-reactive protein level greater than or equal to 3.0 mg/dl. This is a measure of inflammation, which is believed to play an important role in atherosclerosis, or the buildup of fatty deposits in the arteries.
• Metabolic syndrome.

Ghali said patients who have been told to undergo a coronary angiography who believe they may qualify to participate in the study should ask their doctor for more information