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.

CJC-1295 administration resulted in sustained increases in GH and IGF-I levels in healthy adults without serious adverse reactions.

Summary and findings

This study measured the pharmacokinetic and pharmacodynamic effects of CJC-1295, a long-acting GHRH analog, in healthy adults. Participants received ascending doses of CJC-1295 or placebo over a duration of 28 to 49 days. The results indicated sustained increases in GH and IGF-I levels without serious adverse reactions.

Abstract

<h4>Context</h4>Therapeutic use of GHRH to enhance GH secretion is limited by its short duration of action.<h4>Objective</h4>The objective of this study was to examine the pharmacokinetic profile, pharmacodynamic effects, and safety of CJC-1295, a long-acting GHRH analog.<h4>Design</h4>The study design was two randomized, placebo-controlled, double-blind, ascending dose trials with durations of 28 and 49 d.<h4>Setting</h4>The study was performed at two investigational sites.<h4>Participants</h4>Healthy subjects, ages 21-61 yr, were studied.<h4>Interventions</h4>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.<h4>Main outcome measures</h4>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.<h4>Results</h4>After a single injection of CJC-1295, there were dose-dependent 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 were reported.<h4>Conclusions</h4>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 microg/kg. There was evidence of a cumulative effect after multiple doses. These data support the potential utility of CJC-1295 as a therapeutic agent.

Limitations

Not reported in abstract.

Elsewhere in the CJC-1295 without DAC (Modified GRF 1-29) corpus