Prolonged Stimulation of Growth Hormone (GH) and Insulin-Like Growth Factor I Secretion by CJC-1295, a Long-Acting Analog of GH-Releasing Hormone, in Healthy Adults
Teichman, Sam L.;
Frohman, Lawrence A.
Context: Therapeutic use of GHRH to enhance GH secretion is limited
by its short duration of action.
Objective: The objective of this study was to examine the pharmacokinetic
profile, pharmacodynamic effects, and safety of CJC-1295,
a long-acting GHRH analog.
Design: The study design was two randomized, placebo-controlled,
double-blind, ascending dose trials with durations of 28 and 49 d.
Setting: The study was performed at two investigational sites.
Participants: Healthy subjects, ages 21– 61 yr, were studied.
Interventions: CJC-1295 or placebo was administered sc in one of
four ascending single doses in the first study and in two or three
weekly or biweekly doses in the second study.
Main Outcome Measures: The main outcome measures were peak
concentrations and area under the curve of GH and IGF-I; standard
pharmacokinetic parameters were used for CJC-1295.
Results: After a single injection of CJC-1295, there were dosedependent
increases in mean plasma GH concentrations by 2- to
10-fold for 6 d or more and in mean plasma IGF-I concentrations by
1.5- to 3-fold for 9 –11 d. The estimated half-life of CJC-1295 was
5.8 – 8.1 d. After multiple CJC-1295 doses, mean IGF-I levels remained
above baseline for up to 28 d. No serious adverse reactions
Conclusions: Subcutaneous administration of CJC-1295 resulted in
sustained, dose-dependent increases in GH and IGF-I levels in
healthy adults and was safe and relatively well tolerated, particularly
at doses of 30 or 60 g/kg. There was evidence of a cumulative effect
after multiple doses. These data support the potential utility of CJC-
1295 as a therapeutic agent. (J Clin Endocrinol Metab 91:
799 – 805, 2006)