growth hormone deficiency in abdominal obesity (GHDAO)

The Syndrome

Growth hormone (GH) deficiency is a syndrome generally characterized by reduced muscle mass, increased abdominal fat, metabolic abnormalities. A majority of GH deficient subjects have excess visceral fat and are abdominally obese, a combination of factors which significantly increases their cardiovascular risk.

There is currently no approved treatment for patients with a moderate GH deficiency (5-8 ng/mL) and the only therapeutic solution for patients with severe GH deficiency (<5 ng/mL) is the administration of growth hormone, which is associated with undesirable side-effects in certain patient populations such as fluid retention, significant muscle and joint pain as well as glucose intolerance.  

The Product

Tesamorelin is a stabilized analogue of the growth hormone-releasing factor (GRF) that induces growth hormone production in a specific and physiological manner. This compound offers strong potential in a variety of indications, as demonstrated by clinical studies which have shown to increase muscle mass, to reduce visceral abdominal fat and to improve triglyceride levels without compromising glycemic control.

The Strategy

Theratechnologies took the strategic decision to support a Phase 2 clinical study led by the Massachusetts General Hospital and Dr. Steven Grinspoon. Dr. Grinspoon has obtained a grant from the National Institutes of Health to conduct this study evaluating tesamorelin for the treatment of growth hormone deficiency associated with abdominal obesity. This single-center, double blind clinical trial will evaluate tesamorelin in growth hormone deficient abdominally obese subjects. Theratechnologies will retain the benefits from the results generated from this study.