CJC-1295 — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Growth hormone deficiency and growth-hormone secretagogue pharmacology
Anchor outcome. Peak stimulated growth hormone.
Effect as recorded. Mean IGF-1 increased 1.5- to 3.0-fold above baseline and remained elevated for 6 to 11 days after a single dose in a phase 1 study of 11 participants; phase 1, n = 11; no confidence limits reported for the primary pharmacodynamic outcome.[1,2]
Certainty. Low certainty A genuine phase 1 pharmacodynamic result exists and the Institute reports it. It establishes that the compound raises IGF-1 in humans. It does not establish any clinical outcome.
Contributing trials. CJC-PH1-ASCENDING · CJC-PH1-MULTIDOSE. Full structured abstracts are published for each.
Full evidence extract for growth hormone deficiency and growth-hormone secretagogue pharmacology · Indication assessment
§3.2Biological ageing and healthspan endpoints
Anchor outcome. Epigenetic age acceleration.
Effect as recorded. No randomised human evidence identified; —.[2,3]
Certainty. Very low certainty No trial supports any ageing or healthspan claim.
Contributing trials. None identified. The rating reflects an absence of controlled evidence rather than conflicting evidence.
Full evidence extract for biological ageing and healthspan endpoints · Indication assessment
§3.3Sarcopenia and lean-mass preservation during weight reduction
Anchor outcome. Change in appendicular lean mass by DXA.
Effect as recorded. No randomised human evidence identified; —.[3,4]
Certainty. Very low certainty Body-composition claims rest on mechanistic reasoning, not on trial evidence.
Contributing trials. None identified. The rating reflects an absence of controlled evidence rather than conflicting evidence.
Full evidence extract for sarcopenia and lean-mass preservation during weight reduction · Indication assessment
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Teichman SL, Neale A, Lawrence B, Gagnon C, Castaigne JP, Frohman LA. 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. Journal of Clinical Endocrinology & Metabolism 2006;91(3):799–805. doi:10.1210/jc.2005-1536 · PMID 16352683
- Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs 1999;12(2):139–157. doi:10.2165/00063030-199912020-00007 · PMID 18031173
- Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S. Metabolic effects of a growth hormone-releasing factor in patients with HIV. New England Journal of Medicine 2007;357(23):2359–2370. doi:10.1056/NEJMoa072375 · PMID 18052660
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
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