Metabolic Effects of a Growth Hormone–Releasing Factor in Patients with HIV
Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S. N Engl J Med. 2007;357(23):2359–2370. View source ↗
This 26-week multicenter, double-blind, placebo-controlled Phase 3 study randomized 412 adults with HIV-associated abdominal fat accumulation to a daily 2 mg subcutaneous dose of tesamorelin or placebo. The primary endpoint was percent change in visceral adipose tissue (VAT) measured by computed tomography. Tesamorelin produced a mean VAT reduction of approximately 15.2% from baseline, compared with a 5% increase in the placebo arm (between-group difference p<0.001). Triglycerides and the cholesterol-to-HDL ratio improved in the tesamorelin arm, and IGF-1 rose into the upper-normal physiologic range consistent with pulsatile pituitary GH release rather than exogenous GH administration. Glucose parameters and adverse event rates were broadly similar between arms over the 26-week window. The authors concluded that tesamorelin selectively reduced visceral adiposity through stimulation of endogenous GH secretion.
This was the large landmark trial that established what tesamorelin does in humans. Roughly 400 people received either tesamorelin or a placebo injection daily for six months, and researchers measured belly fat with CT scans. The tesamorelin group lost about 15% of their visceral (deep abdominal) fat, while the placebo group gained a little. Importantly, tesamorelin worked by telling the body's own pituitary gland to release growth hormone in its natural rhythm, rather than by adding outside growth hormone.
