FDAnews
www.fdanews.com/articles/71331-insmed-initiates-hiv-associated-lipodystrophy-trial-with-somatokine

Insmed Initiates HIV-Associated Lipodystrophy Trial With Somatokine

April 20, 2005

Insmed has initiated a Phase II clinical trial examining the therapeutic benefit of treating HIV-Associated Lipodystrophy with SomatoKine, the company's proprietary once daily IGF-I therapy.

The Phase II clinical trial is an open-label study designed to evaluate the safety and efficacy of SomatoKine for 12 weeks in 12 subjects with HIV-associated lipodystrophy.

To qualify for inclusion in the study, patients must be between 18 and 65 years of age, have confirmed HIV-1 infection, fat accumulation (visceral adiposity) and evidence of insulin resistance. The primary goal of the study is to determine the effects of SomatoKine on visceral fat and insulin sensitivity.