ITCES Releases Results of Year-Long AVT-12 Controlled Trial

March 5, 2010 - PRLog -- A. Nielsen, P. Anderson, S. Das

Effective weight loss interventions ideally result not only in the promotion of weight loss, but also contribute to favorable changes in metabolic risk factors for chronic disease in overweight and obese subjects.

The weight loss combination drug product, AVT-12 is thought to improve GPR39 affinity of the hormone, obestatin.  Use of combination drug products including agents targeted at distinct regulatory pathways may produce significant additive or synergistic effects on weight loss.

The purpose of this study is to test the efficacy of AVT-12 in overweight and obese individuals as compared to a placebo control group at 12 months. In addition to bodyweight, measures include biochemical factors (total cholesterol, high density lipoprotein, low density lipoprotein, triglycerides, glucose, insulin, leptin and C-reactive protein.

At point of randomization, participants (n=451) were 47(11) (mean [SD]) years of age, with BMI 36.0(3.7) kg/m2, weight 98.1(10.4) kg.

One-year data are available for 94% of study participants (n=424) and weight loss is -27.7(6.7), -3.2(2.8) kg for the treatment group and control group, respectively, a weight loss of -39.3% and -3.4%, respectively.

CRP decreased significantly in the treatment group, from 9.3% in the lowest risk category (CRP less than 1 ng/mL) at baseline, to 44.7% at 12 months, but was essentially unchanged in the control group.

Findings from this study suggest that AVT-12 is an effective weight loss combination drug product and may produce significant favorable changes in risk factors for chronic disease.

The results of the latest AVT-12 trial are promising in that, not only did participants lose substantial excess weight, but also demonstrated a marked improvement in risk-factor related blood profile parameters. In addition, AVT-12 did not produce the problematic rise in blood pressure often elicited by weight loss medications.

The sole side-effect noted was a mild, transient insomnia that persisted 24-48 hours and self-resolved with continued use. This was mentioned by 1.4% of participants and was not sufficient to require participant withdrawal. The exemplary safety record of AVT-12 makes it potentially suitable for Over-the-Counter (OTC) distribution.

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ITCES Corporation partners with innovators to evaluate and develop applied biotherapeutics from concept to market. ITCES delivers timely value to clients by facilitating and analyzing critical research, while protecting intellectual property.