Safety and tolerability of long-acting release recombinant human growth hormone-releasing hormone in adults with growth hormone deficiency

This clinical study conducted by Ionescu and Lawrence Frohman (a recognized authority in neuroendocrinology) evaluated the safety and tolerability of CJC-1295 with DAC (Drug Affinity Complex) in adults with documented growth hormone (GH) deficiency. CJC-1295-DAC is a modified GHRH (growth hormone-releasing hormone) analog that binds to serum albumin through DAC technology, dramatically extending its half-life.

The protocol involved subcutaneous administration of CJC-1295-DAC in single-dose and multiple-dose regimens, with extensive pharmacological and safety monitoring. Results confirmed that the peptide produced sustained elevation of GH levels for several days after a single injection, maintaining physiological pulsatile concentrations rather than constant levels — an important advantage over direct exogenous GH administration.

The safety profile was deemed favorable, with predominantly mild adverse events including injection site reactions and transient headache. No clinically significant changes were observed in cardiovascular, metabolic, or hematologic safety parameters. IGF-1 markers also rose proportionally and sustainably.

The clinical significance of this study lies in validating the concept that endogenous pulsatile stimulation of GH through long-acting GHRH analogs may be a more physiological alternative to direct recombinant GH replacement, which requires daily injections and produces supraphysiological peaks. The data supported the continued clinical development of CJC-1295 as a therapy for GH deficiency in adults.