This is a great option for those who are looking to promote a steady and improved release of GH to get the benefits of increases in growth hormone and subsequently Insulin Like Growth Factor -1 (IGF-1) with almost no side effects. This therapy is effectively used for anti-aging purposes as well as those with inflammatory conditions, disease or those who have low IGF-1 levels.
Between 2001 and 2006 six human clinical trials with the hexadecapeptide AOD9604 have been performed, 893 healthy, in all but one study, clinically obese adults participated in these studies and are the basis of this safety evaluation. The details of the individual studies are listed in supplementary data. The first 3 studies were dose-escalating studies investigating the acute effects of various dosages and two application routes (i.v. and oral) in healthy or obese male subjects. These single dose studies were followed by a 7-day multiple dose study (METAOD004) as well as two long-term clinical trials (METAOD005 and METAOD006) where the safety and tolerability of chronic oral treatment with AOD9604 was investigated.
In plasma, different isoforms and fragments of hGH were found [10]. Research on specific domains and fractions of the protein revealed that they can be assigned to different actions of the protein: In vitro and in vivo experiments have shown that several fragments of the amino terminal region of hGH, namely 1-15, 1-42, 6-13, and 32-46, exhibit an insulin-potentiating action [14-16]. The region hGH 108-129 was found to evoke high mitogenic responses [17], while the carboxy terminus hGH177-191 seemed to be a lipid mobilizing domain, inhibiting the acetyl-CoA carboxylase activity in adipocytes and hepatocytes [18].
Advanced Obesity Drug 9604 (AOD9604), targets fat metabolism directly by enhancing the breakdown of stored fats and inhibiting the synthesis of new fats. It is a peptide drug derived from the fat-reducing activity of human growth hormone (hGH). hGH has been shown to cause fat reduction, but is not suitable as an anti-obesity drug as it also causes an increase in muscle, organ and bone mass as well as causing diabetes to develop. The effectiveness of hGH declines in older people, correlating with the tendency to put on weight as one gets older. In support of this, the clinical trials so far have shown a greater effect of AOD9604 in the older population.
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of a substance; b) the purposes for which a substance is to be used and the extent of use of a substance; c) the toxicity of a substance; d) the dosage, formulation, labelling, packaging and presentation of a substance; e) the potential for abuse of a substance; f) any other matters that the Secretary considers necessary to protect the public health.
Ipamorelin is a man-made peptide that is part of the growth hormone family. Rated as one of the safest in the peptide industry, it has strong growth hormone releasing properties. From this, it is a huge winner with athletes and bodybuilders. This is because it builds muscle and keeps weight down quickly. It works by sending signals to the pituitary gland at the base of the brain and adjusts and controls various body functions through the endocrine system. It binds certain receptors inside cells. This allows cells to respond and change, encouraging growth and regulation of hormones. Ipamorelin can help with:
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