Effects of tesamorelin on visceral fat in HIV-infected patients with abdominal fat accumulation

This phase 3 clinical trial, published in the New England Journal of Medicine, evaluated the efficacy and safety of tesamorelin — a growth hormone-releasing hormone (GHRH) analog — in reducing visceral fat in HIV-infected patients with abdominal lipodystrophy, a common metabolic complication of antiretroviral therapy.

The randomized, double-blind, placebo-controlled study enrolled patients with significant abdominal fat accumulation, who received daily subcutaneous injections of tesamorelin 2 mg or placebo. The results demonstrated that tesamorelin produced a 15-18% reduction in visceral adipose tissue measured by computed tomography, a highly significant difference compared to placebo (p<0.001).

• The reduction in visceral fat was maintained throughout the treatment period
• There was improvement in triglyceride levels and total cholesterol/HDL ratio
• IGF-1 levels increased significantly, confirming activation of the GH axis
• The safety profile was acceptable, with predominantly mild adverse events

This pivotal study was determinant for the FDA approval of tesamorelin (Egrifta) in 2010 as the first drug approved specifically for the treatment of HIV-associated abdominal lipodystrophy, filling an important therapeutic gap for this patient population.