CJC-1295 and Clopidogrel Interaction: What Clinicians and Patients Need to Know

Does CJC-1295 interact with clopidogrel?

FDA identified only three published human studies of CJC-1295, all of the DAC form and all in healthy volunteers, and found no study of any form in people with a disease [1]. These studies gave CJC-1295 or placebo to healthy adults and measured growth hormone and IGF-I; none tested it alongside clopidogrel or in people with coronary disease. That is a gap in the data, not a clean bill of health. FDA's concerns about CJC-1295 include increased heart rate and a systemic vasodilatory reaction [2].

What CJC-1295 is and does

CJC-1295 is an investigational 29-amino-acid analogue of growth hormone-releasing hormone, first described in 2005 and developed by ConjuChem Biotechnologies of Montreal [1][4]. It acts on the pituitary to raise the body's own growth hormone and, through it, IGF-I. After one subcutaneous injection of the DAC form, the estimated half-life was 5.8 to 8.1 days, mean growth hormone rose 2- to 10-fold for 6 days or more, and mean IGF-I rose 1.5- to 3-fold for 9 to 11 days [5].

What the human studies measured

Teichman 2006 was two randomized, placebo-controlled, double-blind, ascending-dose trials of 28 and 49 days in healthy adults; no serious adverse reactions were reported [5]. In Ionescu and Frohman 2006, healthy men aged 20 to 40 received one injection of 60 or 90 micrograms/kg; growth hormone pulsatility was preserved, trough growth hormone rose about 7.5-fold, mean growth hormone 46% and IGF-I 45% [6]. FDA's briefing says a phase 2 trial in HIV-associated lipodystrophy, with 192 enrolled, was ended in 2006 after a participant died, citing news reports; the data were never published, so a causal link is neither shown nor excluded [1].

Where the concerns actually sit

FDA's stated concerns about CJC-1295 include possible immunogenicity for certain routes, impurity and characterization problems, serious adverse events including increased heart rate and systemic vasodilatory reaction, and limited clinical data [2]. Clopidogrel is a platelet inhibitor studied with aspirin in acute coronary syndrome [7] and compared with aspirin in people with a recent ischemic stroke, recent heart attack or symptomatic peripheral arterial disease [8]. Its activation depends mainly on CYP2C19 [3].

Regulatory status

CJC-1295 is not FDA-approved. FDA found no approved product containing any form of it in Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Japan, Norway, Spain or the United Kingdom, and none authorized by the European Medicines Agency [1]. It sits in the 'nominated but withdrawn' table on FDA's page about bulk substances that may raise significant safety risks, with the agency's concerns still posted [2].