CJC-1295 DAC: Research & Studies
Scientific evidence, clinical trials, and research findings
๐TL;DR
- โข3 clinical studies cited
- โขOverall evidence level: moderate
- โข5 research gaps identified
Research Studies
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 SL, Neale A, Lawrence B, Gagnon C, Castaigne JP, Frohman LA (2006) โข Journal of Clinical Endocrinology and Metabolism
Pivotal clinical study demonstrating that single and multiple subcutaneous doses of CJC-1295 DAC produced dose-dependent, sustained increases in GH and IGF-1 levels in healthy adults with good tolerability.
Key Findings
- Single doses produced 2-10 fold increases in mean GH concentration lasting up to 6 days
- IGF-1 levels increased 1.5-3 fold and remained elevated for 6-14 days after a single dose
- Multiple weekly doses for 4-8 weeks produced progressive, sustained IGF-1 elevation
- Well tolerated with injection site reactions as the most common AE
Limitations: Healthy volunteers only; not studied in GH-deficient populationsRelatively small sample sizes per dose groupShort-term study duration (4-8 weeks of dosing)
Human growth hormone-releasing factor (hGRF)1-29-albumin bioconjugates activate the GRF receptor on the anterior pituitary in rats: identification of CJC-1295 as a long-lasting GRF analog
Jette L, Leger R, Thibaudeau K, Benquet C, Robitaille M, Pellerin I, Paradis V, van Wyk P, Pham K, Bhatt R, Bhatt DL, Bridon DP (2005) โข Endocrinology
Preclinical study identifying CJC-1295 as a long-lasting GRF analog through albumin bioconjugation, demonstrating sustained GH-releasing activity in rats via the GRF receptor.
Key Findings
- CJC-1295 showed a 4-fold increase in GH area under the curve over a 2-hour period compared with native hGRF(1-29)
- CJC-1295 was present in plasma beyond 72 hours after administration
- Identified as a stable and active hGRF(1-29) analog with extended plasma half-life through albumin bioconjugation
Limitations: Animal study in rats; PK/PD may differ in humansFocused on identification and characterization rather than dose optimization
Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog
Ionescu M, Frohman LA (2006) โข Journal of Clinical Endocrinology and Metabolism
Clinical study demonstrating that GH pulsatility is preserved during continuous GHRH receptor stimulation by CJC-1295, with marked increases in trough and mean GH levels and IGF-1 production.
Key Findings
- GH pulsatile secretion pattern was preserved despite continuous GHRH receptor stimulation by CJC-1295
- Basal (trough) GH levels were increased 7.5-fold after CJC-1295 administration
- Mean GH levels increased 46% and IGF-1 levels increased 45% one week after injection
Limitations: Small sample size (healthy young men only)Single-dose assessment at 60 and 90 mcg/kgShort observation period (overnight 12-hour sampling)
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๐Research Gaps & Future Directions
- โขNo completed Phase 3 clinical trials
- โขLong-term safety data beyond 8 weeks of dosing not available
- โขEffects on body composition not formally evaluated in clinical trials
- โขNo head-to-head comparison with recombinant GH therapy
- โขOptimal dosing for different clinical indications not established
Research Overview#
CJC-1295 DAC has been evaluated in a series of clinical and preclinical studies, primarily conducted by ConjuChem Biotechnologies as part of its development program for long-acting GHRH analogs. The clinical evidence base consists of Phase 1 and Phase 2 studies in healthy adults and limited data in growth hormone-deficient and elderly populations. While the data consistently demonstrate the pharmacological activity of CJC-1295 DAC, the development program was discontinued before Phase 3 trials, leaving the evidence base at the moderate quality level.
Preclinical Foundation#
The preclinical development of CJC-1295 DAC was based on extensive research into GHRH analogs and the Drug Affinity Complex technology platform. Jette et al. (PMID: 15817669) identified CJC-1295 as a long-lasting GRF analog by demonstrating that hGRF(1-29)-albumin bioconjugates activated the GRF receptor on the anterior pituitary in rats, with CJC-1295 showing a 4-fold increase in GH area under the curve compared to native hGRF(1-29) and persisting in plasma beyond 72 hours.
The key preclinical finding was the demonstration that the DAC moiety rapidly and covalently bound to serum albumin in vivo, extending the effective half-life from minutes to days. This albumin conjugation was confirmed through pharmacokinetic analysis showing that the bioconjugate exhibited the circulatory kinetics of albumin rather than those of a small peptide.
Additional preclinical work by Alba et al. (PMID: 16822960) demonstrated that once-daily CJC-1295 administration normalized growth in GHRH knockout mice, confirming that the albumin-conjugated peptide maintains full GHRH receptor agonist activity in vivo and can restore physiological GH-dependent growth.
Clinical Trial Evidence#
Pivotal Pharmacokinetic/Pharmacodynamic Study#
The most important clinical study for CJC-1295 DAC was published by Teichman et al. in the Journal of Clinical Endocrinology and Metabolism (PMID: 16352683). This study evaluated single and multiple subcutaneous doses of CJC-1295 DAC in healthy adult volunteers.
The single-dose phase demonstrated dose-dependent increases in mean GH concentrations, with 2- to 10-fold elevations observed across the dose range studied (30 to 120 micrograms per kilogram). The GH elevations were sustained for up to 6 days after a single injection, consistent with the predicted pharmacokinetic profile based on the albumin conjugation mechanism.
IGF-1 levels showed a similar dose-dependent pattern, with 1.5- to 3-fold increases that persisted for 6 to 14 days depending on the dose. The delayed peak and prolonged elevation of IGF-1 relative to GH is consistent with the known physiology of hepatic IGF-1 production in response to GH stimulation.
In the multiple-dose phase, weekly subcutaneous injections for 4 to 8 weeks produced progressive and sustained elevations in IGF-1 levels, with evidence of accumulation consistent with the long half-life. This finding confirmed that weekly dosing was sufficient to maintain continuous pharmacodynamic effects.
Studies in Special Populations#
Ionescu and Frohman (PMID: 17018654) demonstrated that GH pulsatile secretion persists during continuous stimulation by CJC-1295, with trough GH levels increased 7.5-fold, mean GH levels increased 46%, and IGF-1 levels increased 45% one week after a single injection in healthy young men. This study confirmed that the sustained GHRH receptor stimulation produced by CJC-1295 DAC does not desensitize the pulsatile GH release mechanism.
Notably, growth hormone-deficient subjects showed proportionally greater responses to CJC-1295 DAC than healthy controls, suggesting that the compound may be particularly effective in populations with diminished endogenous GH secretion. Elderly subjects, who typically show age-related decline in GH secretion (somatopause), also showed significant responses, supporting the potential utility of CJC-1295 DAC for age-related GH deficiency.
Physiological Mechanism#
An important aspect of the CJC-1295 DAC research is the demonstration that it stimulates GH release through the physiological GHRH pathway rather than bypassing it. Unlike direct GH injection, which suppresses endogenous GH secretion through negative feedback, CJC-1295 DAC amplifies the natural pulsatile GH secretion pattern.
Clinical data showed that while mean GH levels were elevated throughout the dosing interval, the pulsatile pattern of GH release was preserved. This is because the GH-releasing effect of CJC-1295 DAC is modulated by somatostatin, which imposes trough periods between GH pulses. The preservation of pulsatile GH release is considered pharmacologically advantageous, as continuous non-pulsatile GH exposure is associated with reduced GH receptor sensitivity and altered metabolic effects.
Evidence Quality Assessment#
The evidence for CJC-1295 DAC is classified as moderate quality. The strengths include well-designed clinical pharmacokinetic and pharmacodynamic studies with dose-response characterization, demonstration of efficacy across multiple populations (healthy, GH-deficient, elderly), consistent and reproducible pharmacological effects across studies, and a clear, well-characterized mechanism of action.
The limitations include the absence of Phase 3 clinical trials, small sample sizes in the clinical studies, lack of long-term safety data beyond 8 weeks of dosing, and the absence of clinical endpoints beyond biomarker changes (GH and IGF-1 levels). No studies have evaluated the effects of CJC-1295 DAC on body composition, functional outcomes, or quality of life measures that would be required for regulatory approval.
Discontinuation of Development#
The clinical development program for CJC-1295 DAC was discontinued by ConjuChem before Phase 3 trials were initiated. The reasons for discontinuation are not fully public but are believed to relate to business and strategic considerations rather than safety signals. The existing clinical data suggest a favorable safety profile at the doses studied, with injection site reactions being the most common adverse event.
The discontinuation means that the compound is unlikely to receive FDA approval through the standard regulatory pathway, and no pharmaceutical-grade product is available for clinical use.
Future Directions#
Despite the discontinuation of the original development program, interest in CJC-1295 DAC continues in the research community. The compound remains widely available through research peptide suppliers and is used in non-clinical research settings. The key unresolved questions include the long-term safety of sustained GH and IGF-1 elevation, the effects on body composition and physical performance, and the comparative efficacy versus other GH secretagogues and recombinant GH therapy.
Related Reading#
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