Treatment with the synthetic human growth hormone-releasing factor, tesamorelin, resulted in a significant loss of visceral adipose tissue—deep belly fat—compared with a placebo in people with lipodystrophy, according to a new article published in the December 6 issue of the New England Journal of Medicine (NEJM).
The tesamorelin study is a 52-week trial involving 412 patients with lipodystrophy. During the first 26 weeks, 273 patients received tesamorelin and 137 received a placebo. During the second 26 weeks of the study, those who’d originally received placebo switched to tesamorelin, while those who originally received tesamorelin either stayed on the drug or were switched to placebo.
In the NEJM article, Julian Falutz, MD, of the Montreal General Hospital at the McGill University Health Centre, and his colleagues report the results from the first 26 weeks of the study. At week 26, those who’d received tesamorelin had a 15.2 percent decrease in visceral adipose tissue, compared with a 5 percent increase in those who received a placebo. Moreover, people in the tesamorelin group had greater improvements in cholesterol and insulin function than those who received a placebo.
There was no difference in the incidence of serious side effects between those receiving tesamorelin or placebo. However, those taking tesamorelin were more likely to discontinue the drug due to side effects than those in the placebo group.
Preliminary data from the second half of the study were reported at the 2007 European AIDS Conference in Madrid. Final results from the 52-week study have not yet been published in a peer-reviewed medical journal.