A study to evaluate the effect of a new weight loss drug on body weight and appetite of subjects with Prader-Willi Syndrome

Cannabinoid system has been known to modulate feeding behavior and appetite. Cannabinoid receptor CB1 is involved in the regulation of appetite, body weight, and metabolism, and is found in the central nervous system (CNS), autonomic gastric nerve endings of the peripheral nervous system (PNS), and other key cells involved in the body energy metabolism, including fat cells. A new CB1 receptor blocking drug, rimonabant has shown promising results in the treatment of obesity and its cardiovascular complications in adults with obesity. Studies have shown that in addition to the inhibitory effect on food intake, rimonabant directly increases energy expenditure. Additionally, CB1 receptor has been identified in normal cells of the anterior pituitary in brain. Activation of CB1 receptor can decrease growth hormone secretion from pituitary, while blocking the CB1 by rimonabant can block this effect on the growth hormone secretion.

Dr. Angulo and Dr. Motaghedi are conducting a randomized double blind controlled study, evaluating the effect of this investigational drug on the body weight and fat content of adult patients with Prader-Willi syndrome. In addition, effect of this investigational drug on blood sugar, lipids, Ghrelin, Leptin and GH regulated IGF1 and IGFBP-3 will be tested. Patients will be followed for the duration of 6 month. Currently, this trial is open for recruitment for adults with PWS who are not taking growth hormone or psychotropic medications. Study participants are now being recruited.

Please contact Dr. Roja Motaghedi at 212-746-3462 at New York-Presbyterian Hospital/Weill Cornell Medical Center for further information.

edited: 02/21/2008