As per the FDA’s special protocol assessment process, the study was powered to detect an 8% reduction in visceral adipose tissue (VAT) versus placebo. The study met its primary endpoint as well as important secondary endpoints confirming the positive results obtained in the company’s initial Phase III study.
The primary endpoint for the study was VAT reduction while the four secondary endpoints were positive changes in body image (belly appearance distress), triglyceride levels, the total cholesterol to high-density lipoprotein (HDL) ratio and IGF-1 levels.
Patients treated with tesamorelin for 26 weeks achieved an average of 11% decrease in VAT versus baseline and 10% versus placebo. In absolute terms, the average VAT reduction was -20.6 square centimeters. Body fat was preferentially lost in the visceral cavity, with no significant changes in subcutaneous adipose tissue.
This study also demonstrated that treated patients significantly improved their belly appearance distress compared to the placebo group. This is considered to be an important endpoint because of its implications for patient adherence to HIV regimens.
With respect to lipid profiles, a trend for improvement in triglyceride levels was recorded for the treated group versus placebo (p equals 0.08) and was significantly different versus baseline (p equals 0.006). There was no significant impact on the total cholesterol to HDL cholesterol ratio. IGF-1 mean levels were within physiological range and increased by 73% compared to placebo (p less than 0.001).