Participants wanted to test experimental weight-loss drug
Volunteers are needed to test the safety and effectiveness of an experimental weight-loss drug that has yielded promising results in about half of the people who tried it.
By the numbers
Overweight or obese adults:
DHEC 2010 study
The drug, Contrave, is designed to reduce appetite, increase metabolism and control cravings and overeating. It is taken in pill form.
How to enroll
Four local locations are participating in the study:
Coastal Carolina Research Center: Go to www.coastalcarolinaresearch.com, click on weight loss/cardiac risk link under current studies.
Medical University: Send email to Suzanne Kuker at email@example.com.
Medical Research South: Go to www.researchsouth.com, click on enroll in a trial link.
PMG Research: Go to www.pmg-research.com, click on weight loss/obesity link.
Candidates are men age 45 or older or women age 50 or older who need to lose weight and have a cardiovascular risk factor such as heart disease or type 2 diabetes. Those selected will receive a comprehensive weight management program called WeightMate.
Applications will be accepted for the next two weeks, said Patrick O’Neil, director of the Medical University of South Carolina’s Weight Management Center.
The study is part of clinical trials that are required by the U.S. Food and Drug Administration before it decides whether to approve the drug for general use.
Because of problems in the past with weight loss drugs, the FDA is cautious when it comes to applications for a new drug, O’Neil said.
“Obesity medicines don’t have a pretty history,” he said.
The effectiveness of Contrave has been studied in 4,500 people so far. During a 12-month clinical trial, 53 percent of those who took the drug lost five percent or more of their body weight. Many saw improved cholesterol numbers, blood sugar levels and smaller waistlines. The drug is being evaluated in 10,000 patients at 300 locations nationwide.
“No medication is going to work for everybody, and no medication is going to work by itself,” O’Neil said.
Contrave combines two drugs, naltrexone and buproprion. Naltrexone is approved for treatment of opiod addiction and alcohol dependence.
Approved uses for buproprion include depression, smoking cessation and seasonal affective disorder. Both have been used for more than 25 years, O’Neil said.
Coastal Carolina Research Center, MUSC, Medical Research South and PMG Research are conducting the study locally.
Those who qualify receive physical exams, study medication, laboratory tests and a weight management support program at no charge. Participants will take either Contrave or a placebo. The study is expected to take up to four years. There are eight study visits in the first year. Compensation may be provided for time and travel expenses, according to Coastal Carolina Research Center.
An average 25-pound weight loss was reported in people taking Contrave for six months when combined with a weight management program, Orexigen said.
Obesity-related conditions include heart disease, stroke, type 2 diabetes and certain types of cancer, which are some of the leading causes of preventable death, the Centers for Disease Control and Prevention says. In 2008, medical costs associated with obesity were estimated at $147 billion. The medical costs for people who are obese were $1,429 higher for the year than those of normal weight.