clinical trial · PMID 16352683

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 — VialBase Research

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Last updated · 2006 · Teichman, S.L., Neale, A., Lawrence, B., Gagnon, C., Castaigne, J.P., Bhatt, R.S. · Journal of Clinical Endocrinology and Metabolism
Key findings
  • Single dose of CJC-1295 DAC elevated GH and IGF-1 for 6-14 days
  • 2-10 fold increases in GH secretion
  • Dose-dependent IGF-1 elevation sustained for up to 28 days

Summary

This pivotal human pharmacokinetic study demonstrated that CJC-1295 with Drug Affinity Complex (DAC) produces prolonged stimulation of GH and IGF-1 secretion from a single subcutaneous injection. The DAC modification enables albumin binding, extending the half-life from minutes (native GHRH) to approximately 8 days.

Key Findings

  • Single injection of CJC-1295 DAC produced sustained GH elevation for 6+ days
  • 2-10 fold increases in mean GH concentration (dose-dependent)
  • IGF-1 levels elevated 1.5-3 fold, sustained for up to 28 days after single dose
  • Half-life of CJC-1295 DAC: approximately 5.8-8.1 days
  • Multiple-dose regimens showed sustained IGF-1 elevation without tachyphylaxis
  • Well-tolerated with injection site reactions as most common adverse event

Methodology

Phase 1/2, single- and multiple-dose escalation study in 33 healthy adults aged 21-61. Single ascending doses (30, 60, 125, 250 μg/kg) and multiple weekly doses tested. Frequent GH sampling (q20min over 24h) and serial IGF-1 measurements.

Limitations

  • Small sample size (n=33)
  • Healthy adults — may not represent GH-deficient or aging populations
  • DAC version differs from “no-DAC” CJC-1295 commonly used in practice
  • No long-term safety data beyond 4 weeks
  • Supraphysiological GH/IGF-1 elevation raises safety concerns (cancer risk, insulin resistance)
  • No assessment of body composition or functional outcomes

Relevance to Content

The most important clinical reference for CJC-1295. Establishes human evidence for sustained GH/IGF-1 stimulation. Critical distinction: this study used CJC-1295 with DAC — most peptide clinics use “CJC-1295 no DAC” (also called modified GRF 1-29), which has different pharmacokinetics. Content must be clear about this distinction.

See Also