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Two studies testing new weight-loss drug

by Mary Helen Yarborough
Public Relations
Two studies under way in MUSC’s Weight Management Center are testing a new drug aimed at reducing appetite as a way to prevent and treat diseases related to obesity.
Both studies are recruiting participants for the year-long trial of lorcaserin, developed by San Diego-based Arena Pharmaceuticals, which also is sponsoring the studies.
“These studies combine the use of an investigational medication, developed for use as a possible weight-loss therapy, with a behaviorally-based lifestyle change program to help participants make long-term diet and activity changes,” said Patrick O’Neil, Ph.D., Weight Management Center director. “The medication is being studied to learn whether it will help participants reduce their calorie intake.”
The drug activates a subtype of serotonin receptor in the brain that is involved with the regulation of appetite and food intake. “These trials are designed to learn whether this will result in improved weight loss,” O’Neil said.
The drug does not alter a person’s taste of food or energy expenditure, O’Neil explained. MUSC is one of about 100 centers studying the safety and efficacy of the drug for weight loss.
The drug has shown promise in animal trials and in very early human trials, O’Neil said, which warrants further investigation. It currently is not approved by the Food and Drug Administration, and is one of a number of drugs being tested for this purpose.
One of the two trials focuses on people with type 2 diabetes and will involve monitoring not only changes in weight but also blood sugar control. The other weight loss trial is for people who do not have type 2 diabetes and who are generally healthy. Other health factors related to obesity will be measured in both studies.
Previous studies have shown that even modest weight loss, such as 10 percent of initial weight (e.g., a 20-pound loss for a 200-pound person) can help many overweight diabetics improve their blood sugar control. It may also help to prevent diabetes. In one landmark study, overweight people at risk for diabetes who lost about 7 percent of their start weight had a 58 percent lower rate of developing diabetes during the next four years.
In the study for individuals with type 2 diabetes, the center is hoping to recruit between 10 and 20 participants. In the second study, researchers are seeking up to 40 participants.
In general, these studies will last about a year. Participants will have a health screening, attend at least 17 clinic visits at the center, and have three visits for an echocardiogram at a facility in the Charleston area.
Participants will either receive the drug or placebo twice a day throughout the duration of the study.
Once accepted into the study, participants will receive weight management counseling (diet, physical activity, behavior modification) at every visit. At various visits throughout the study, participants can expect the following procedures: a physical exam, blood draws, urine collections, electrocardiograms, echo-cardiograms, oral interview, measurement of vital signs, weight, height, and waist, and the completion of questionnaires.
To receive more information, call the Weight Management Center at 792-5577.  State whether you are inquiring about the study for diabetics or the one for non-diabetics. For faster receipt of information, send an e-mail to with “Study D” in the subject line for the diabetic study or “Blue Study” in the subject line for the non-diabetic study.


Friday, April 25, 2008
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