Soon available worldwide: sustained-release growth hormone LB03002

top

The Korean pharmaceutical company LG Life Sciences has been producing the growth hormone Declage since 2007. It’s available in Korea and some neighbouring countries, but not yet elsewhere in the world. Once Declage becomes more widely available then thousands of chemical athletes might be able to add another interesting concoction to their arsenal. Declage contains LB03002, a nanotechnological growth hormone preparation that users only need to inject once a week.

The Korean pharmaceutical company LG Life Sciences has been producing the growth hormone Declage since 2007. It’s available in Korea and some neighbouring countries, but not yet elsewhere in the world. [Asia Pacific Biotech 2008;12(3):22-8.] Once Declage becomes more widely available then thousands of chemical athletes might be able to add another interesting concoction to their arsenal. Declage contains LB03002, a nanotechnological growth hormone application that users only need to inject once a week.

LB03002 is an MCT oil-based injectable. The oil contains myriads of small globules of hyaluronic acid. The growth hormone molecules are confined within these globules and after injection they gradually ooze out. Think of LB03002 as a growth hormone depot, which you can inject subcutaneously into the abdomen, like insulin.

1

The trials required before LB03002 can be launched in the US, Canada or the EU are still underway. Publications with data from the trials have been appearing since 2006 and these are positive. [PubMed]

One of these was published in 2006 by researchers at the Ludwig-Maximilians Universitaet in Munich and presented the results of a small human study. [J Clin Endocrinol Metab. 2006 Aug;91(8):2926-30.] The figure below is taken from this. It shows the growth hormone levels of adult test subjects who either produced no or insufficient amounts of growth hormone.

2

After being injected with a regular growth hormone preparation the level drops quickly, but after being injected with LB03002 the subjects’ growth hormone level remained high for a number of days, even when they were given weekly injections of the substance for a period of 5 weeks [W5].

In 2011 doctors at Massachusetts General Hospital published the results of a larger human study. [J Clin Endocrinol Metab. 2011 Jun;96(6):1718-26.] In this study, fifty test subjects with adult growth hormone deficiency were given a weekly injection with a placebo [white blocks] for six months. One hundred subjects were given a weekly subcutaneous injection containing LB03002 [grey blocks]. During the period that the experiment lasted the LB03002 group lost one kilogram of fat and their lean body mass increased by two kilograms.

3

Many chemical athletes use growth hormone because it boosts the synthesis of the hormone IGF-1. IGF-1 is strongly anabolic. When doctors at the Massachusetts General Hospital gave adult subjects with growth hormone deficiency weekly injections of LB03002 for two consecutive periods of six months, they observed that the concentration of IGF-1 rose sharply during the first weeks after the injections as a result. [Pituitary. 2012 Aug 23. [Epub ahead of print].]

IGF-1 remains active in the blood if it can attach itself to the binding protein IGF-BP-3.

4

A trial has even been published in which children with retarded growth as a result of growth hormone deficiency were successfully given LB03002 for three years in a row. [J Clin Endocrinol Metab. 2012 Feb;97(2):400-7.]

LG Life Sciences has asked the FDA to approve LB03002. [ASD Reports 7 March 2012] Approval is still pending.

Analysts have great expectations for LB03002. If users only have to inject once a week, they reason, then the number of growth hormone users in pursuit of an anti-aging solution may well rise dramatically.

Three-year efficacy and safety of LB03002, a once-weekly sustained-release growth hormone (GH) preparation, in prepubertal children with GH deficiency (GHD).

Péter F, Bidlingmaier M, Savoy C, Ji HJ, Saenger PH.

Source

Buda Children’s Hospital, 1023 Budapest, Hungary.

Abstract

BACKGROUND:

GH treatment currently requires daily sc injections, resulting in suboptimal compliance. A GH regimen with fewer injections may offer patients and caregivers a less arduous option. LB03002 is a novel sustained-release GH formulation for once-weekly dosing.

PATIENTS AND METHODS:

GH-deficient, GH-naive prepubertal children were randomized to four groups who received 0.2 mg/kg/wk LB03002 for 12 months, followed by 0.5 mg/kg/wk for another 24 months (n=13); 0.5 mg/kg/wk LB03002 for 36 months (n=13); 0.7 mg/kg/wk LB03002 for 12 months, followed by 0.5 mg/kg/wk for another 24 months (n=13); or daily GH 0.03 mg/kg/d for 24 months, switched to 0.5 mg/kg/wk LB03002 for 12 months (n = 12).

RESULTS:

Height velocity increased in all groups; the increase was less for the 0.2 mg/kg/wk LB03002 group at 12 (P = 0.008) and 24 months (P = 0.030), with no statistically significant differences at any time for the 0.5 mg/kg/wk and 0.7 mg/kg/wk LB03002 groups, vs. daily GH. Height sd score gain at 12 months was significantly (P = 0.023) less for the 0.2 mg/kg/wk group (1.05 ± 0.38) than daily GH (1.47 ± 0.29), but with no statistically significant difference for the 0.5 mg/kg/wk (1.37 ± 0.39) and 0.7 mg/kg/wk (1.50 ± 0.44) LB03002 groups vs. daily GH. There were no significant differences in height sd score gain between any groups at 24 and 36 months. Bone maturation did not differ for any LB03002 dose compared with daily GH. Serum IGF-I concentrations increased as expected, with no long-term differences between groups. Mean fasting glucose and glycosylated hemoglobin concentrations did not exceed normal ranges for any treatment group at any time.

CONCLUSION:

LB03002 at doses of 0.5 mg/kg/wk and 0.7 mg/kg/wk was shown to be effective and safe with once-weekly dosing in GH-deficient children, and 0.5 mg/kg/wk LB03002 was chosen as the optimal dose for long-term assessment.

PMID: 22162481 [PubMed – indexed for MEDLINE]

Source: http://www.ncbi.nlm.nih.gov/pubmed/22162481