CJC-1295 Liver Function Impact: What the Clinical Data Actually Show

What CJC-1295 does, and where the liver sits

CJC-1295 DAC acts like GHRH on the pituitary to release growth hormone, which in turn raises IGF-I [2][3]. After a single subcutaneous injection the estimated half-life was 5.8 to 8.1 days, mean plasma GH rose 2- to 10-fold for six days or more, and mean IGF-I rose 1.5- to 3-fold for 9 to 11 days [2]. In healthy men given 60 or 90 micrograms/kg, GH pulse frequency and size were unchanged, while between-pulse GH rose about 7.5-fold and IGF-I rose 45% [3].

What the human trials measured

Teichman and colleagues ran two randomized, placebo-controlled, double-blind, ascending-dose trials of 28 and 49 days in healthy adults aged 21 to 61: single doses in the first, two or three weekly or biweekly doses in the second [2]. Across the human work, doses ran about 30 to 250 micrograms/kg; these are study doses, not recommended doses [1][2]. The stated outcomes were peak concentration and area under the curve for GH and IGF-I, plus standard pharmacokinetic parameters [2]. No serious adverse reactions were reported [2].

FDA's summary describes injection-site reactions in about 70% of treated subjects in the first trial and in all treated subjects in the second, headache in 63% versus 14% on placebo in the first trial, flushing and transient low blood pressure in about 30% of treated subjects in the first trial, and transient diarrhea [1][2]. In its summary of the Ionescu and Frohman study, no serious adverse events were seen, and dose-dependent increases in heart rate plus temporary injection-site redness and tenderness were reported [1].

Is there any liver signal?

The events the human studies describe are injection-site, vascular, headache and gastrointestinal; none is a liver finding [1][2][3]. That does not establish liver safety: the studies were short, small and mostly single-dose, and healthy volunteers are not people with fatty liver, hepatitis or cirrhosis [1].

What FDA flagged for growth-hormone-raising peptides is the risk of GH and IGF-I elevation itself, meaning the risks listed on approved growth hormone labels, including glucose intolerance and diabetes, fluid retention and tumor growth concerns [1]. FDA's compounding page adds possible immunogenicity for certain routes, impurity and characterisation problems, and serious adverse events including increased heart rate and a systemic vasodilatory reaction, and calls the available clinical data limited [4].