New Phase II, NIH-sponsored Study Demonstrates Metabolic Effects of Tesamorelin in Obese Subjects With Reduced Growth Hormone Secretion
- Category: Proteins and Peptides
- Published on Wednesday, 27 June 2012 20:32
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MONTREAL, Canada I June 27, 2012 I Theratechnologies Inc. (TH.TO)(THER) is pleased to announce that results of a study entitled Metabolic Effects of a Growth Hormone-Releasing Factor in Obese Subjects with Reduced Growth Hormone Secretion were presented yesterday at ENDO 2012. The study was conducted at the Harvard Clinical Translational Science Centre at the Massachusetts General Hospital by Dr. Steven K. Grinspoon and was sponsored with grants from the U.S. National Institutes of Health (NIH).
The placebo-controlled study demonstrated that, among obese subjects with relative reductions in growth hormone (GH), tesamorelin selectively reduces visceral adipose tissue (VAT) in the abdominal area, without significant effects on subcutaneous adipose tissue (SAT). Tesamorelin was also shown to improve triglycerides, C-reactive protein and carotid intima medial thickness (cIMT), without aggravating glucose. These data suggest a functional consequence of reduced GH secretion in obesity and demonstrate an improved cardiovascular disease (CVD) risk profile resulting from tesamorelin. In addition, this study suggests, more broadly, that strategies to selectively reduce VAT and spare SAT may improve CVD risk in obesity. The results occurred in the context of a dosing algorithm designed to keep insulin-like growth factor-1 (IGF-1) within the normal physiological range. Tesamorelin is not approved for the treatment of obese patients with reduced growth hormone secretion. The complete abstract is available at http://www.abstracts2view.com/endo/.
"It has long been demonstrated that obesity is associated with relative reductions in GH secretion. Results from this study show that increasing GH levels with tesamorelin can have positive impacts on abdominal fat in this patient population. Moreover, data from this model suggest that selectively reducing VAT without affecting SAT improves known cardiovascular risk factors associated with obesity," stated Dr. Grinspoon.
"These findings are very encouraging, particularly as we anticipate beginning human testing with our second generation growth hormone-releasing factor peptide, TH1173, early next year. The results of Dr. Grinspoon's study will help narrow down indications for future clinical trials," stated John-Michel T. Huss, President and Chief Executive Officer of Theratechnologies.
To assess the effects of augmenting GH secretion on body composition and cardiovascular risk factors, 60 obese patients with relative reductions in growth hormone (peak response to GH-releasing hormone (GHRH)-arginine testing less than or equal to9 ug/L) were randomly assigned to a GHRH1-44 analogue, tesamorelin 2 mg SC QD or placebo for 12 months. Treatment effect was determined by longitudinal linear mixed effects modeling. 83% of subjects completed 6 months and 62% 12 months, without differences in discontinuation rates between the groups. Abdominal VAT, cIMT, logCRP, and triglycerides improved significantly in the tesamorelin group versus placebo. Results show that the changes amounted to a 19% reduction in visceral fat, 6% reduction in cIMT and 20% reduction in triglycerides in the tesamorelin group, relative to changes in the placebo group. No significant effects on abdominal SAT were seen. Mean IGF-1 levels increased by 90% in the tesamorelin group. No changes in fasting, 2-hour glucose or HbA1c were seen. There were no serious adverse events in both groups. The most commonly reported adverse events were hypertension (tesamorelin, n=8; placebo, n=5; p=0.27), hyperglycemia (tesamorelin, n=3; placebo n=2; p=0.70), tingling/paresthesia (tesamorelin, n=3; placebo n=1; p=0.33) and peripheral edema (tesamorelin, n=3; placebo, n=1; p=0.33). However, none of these differences were statistically significant.
Theratechnologies (TH.TO)(THER) is a specialty pharmaceutical company that discovers and develops innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor peptides. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR at www.sedar.com and on the Securities and Exchange Commission's website at www.sec.gov.