K4 Elite
K4 Elite
CJC-1295 (DAC:GRF) is a tetrasubstituted analogue of human GHRH(1-29) carrying a C-terminal maleimidopropionamide 'Drug Affinity Complex' that covalently binds serum albumin after injection, extending its half-life to roughly 6-8 days. It was developed by ConjuChem (Canada). Published human data consist of two small randomised placebo-controlled ascending-dose studies in healthy adults (Teichman et al., JCEM 2006) and a single-dose GH-pulsatility study in healthy young men (Ionescu & Frohman, JCEM 2006). A Phase 2 trial in HIV-associated visceral obesity (NCT00267527) was halted in July 2006 after the death of a participant in Argentina; the trial data were never published and development ceased. Note: products sold as 'CJC-1295 without DAC' or 'Mod GRF (1-29)' lack the albumin-binding group and are not the compound studied in these trials; their closest published analogue data are those for sermorelin (GHRH 1-29).
Each row records what a published study did: who it enrolled, the regimen it administered to those subjects, and what it reported. These are historical study descriptions, not protocols to follow.
| Study | Population | Regimen as reported | Primary findings |
|---|---|---|---|
| Teichman et al., J Clin Endocrinol Metab 2006 (two randomised, placebo-controlled, double-blind ascending-dose studies) | Healthy adults aged 21-61 years at two investigational sites | In the first 28-day study participants received a single subcutaneous injection of CJC-1295 at one of four ascending doses or placebo; in the second 49-day study participants received two or three weekly or biweekly subcutaneous doses or placebo. | A single injection produced dose-dependent 2- to 10-fold increases in mean plasma GH for 6 or more days and 1.5- to 3-fold increases in IGF-I for 9-11 days; the estimated half-life was 5.8-8.1 days; after multiple doses IGF-I remained above baseline for up to 28 days; no serious adverse reactions were reported, and the authors described tolerability as acceptable particularly at 30 or 60 µg/kg. |
| Ionescu & Frohman, J Clin Endocrinol Metab 2006 (single-dose GH-pulsatility study) | Healthy men aged 20-40 years | Participants received a single subcutaneous injection of CJC-1295 at 60 or 90 µg/kg, with overnight 12-hour blood sampling every 20 minutes before and one week after injection. | GH pulsatility was preserved; basal (trough) GH rose 7.5-fold, mean GH by 46% and IGF-I by 45%, with no significant difference between the two doses. |
| Sackmann-Sala et al., Growth Horm IGF Res 2009 (serum proteomics substudy) | Healthy young adult men (n=11) | Sera were analysed before and one week after a CJC-1295 injection by two-dimensional gel electrophoresis. | Apolipoprotein A1 and transthyretin isoforms decreased and beta-haemoglobin and albumin/immunoglobulin fragments increased after treatment, proposed as candidate biomarkers of GH/IGF-1 action. |
| ConjuChem GH100-013 Phase 2, HIV-associated visceral obesity (terminated; unpublished) Registry: NCT00267527
|
HIV-infected adults aged 18-65 on stable antiretroviral therapy with HIV-associated visceral obesity and BMI >24 and <30 kg/m2 (registry planned enrolment 120; contemporaneous press reporting cited 192 enrolled) | Per contemporaneous reporting, participants were randomised to once-weekly subcutaneous CJC-1295 with a three-week escalation to a low dose (60, 90, 120 µg/kg) or high dose (60, 120, 240 µg/kg) or placebo, continued for a further nine weeks (12 weeks total). | The study was stopped by the sponsor on 17 July 2006 after a participant at an Argentine site died shortly after a study injection; ClinicalTrials.gov lists the study as terminated and no results were published. |
| Jetté et al., Endocrinology 2005 (rat pharmacology) | Normal male Sprague-Dawley rats; cultured rat anterior pituitary cells | Maleimido derivatives of hGRF(1-29) including CJC-1295 were administered subcutaneously to rats. | CJC-1295 produced a 4-fold increase in GH area under the curve over 2 hours compared with hGRF(1-29) and remained detectable in plasma bound to albumin beyond 72 hours. |
Effects recorded in the cited reports. Frequencies are those the source reported, in the population that source studied.
| Effect | Frequency / context | Source |
|---|---|---|
| Death during Phase 2 trial (acute myocardial infarction reported) | One participant at an Argentine site died shortly after receiving a study injection in the 12-week HIV visceral-obesity Phase 2 trial (July 2006); the sponsor halted the study and the cause and relationship to drug were under investigation at the time of reporting. Trial data were not published. Contemporaneous news reporting (aidsmap) is the only public account; causality was never established in the peer-reviewed literature. | Lipodystrophy study halted after patient death (aidsmap, 31 July 2006) ↗ |
| Sustained elevation of GH and IGF-I | Dose-dependent 2- to 10-fold GH increases for 6+ days and 1.5- to 3-fold IGF-I increases for 9-11 days after a single dose; IGF-I remained above baseline for up to 28 days after multiple doses (Teichman et al., 2006). | 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 ↗ |
| Tolerability at higher doses | The authors described CJC-1295 as 'relatively well tolerated, particularly at doses of 30 or 60 µg/kg', implying poorer tolerability at higher doses; no serious adverse reactions were reported (Teichman et al., 2006). Event-level frequencies are not given in the abstract. | 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 ↗ |
| Dose-dependent increase in heart rate; transient injection-site redness and tenderness | Described in the Ionescu & Frohman 2006 study of single 60 or 90 µg/kg doses in healthy men as the most commonly observed effects, of short duration (statement from the paper's full text as quoted in public materials submitted to the FDA Pharmacy Compounding Advisory Committee, December 2024). | Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog ↗ |
| Post-marketing / spontaneous reports | In its December 2024 Pharmacy Compounding Advisory Committee briefing, FDA proposed that CJC-1295 (free base and acetate) and CJC-1295 DAC (free base, acetate and trifluoroacetate) NOT be included on the 503A bulk drug substances list. Public docket materials quoting FDA's evaluation state that a FAERS search through June 2024 retrieved two reports (both excluded for insufficient information or no adverse event) and that CAERS 2004-2024 retrieved none. | FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, December 4, 2024 (Points to Consider); docket FDA-2024-N-4777 public submission ↗ |
No interactions with a verifiable citation have been indexed for this compound.
Exclusions and label contraindications recorded in the cited sources.