CJC-1295 DAC in healthy adults: two early-phase human trials

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Case Study · Research Summary

CJC-1295 DAC in Healthy Adults: Findings From Two Early-Phase Human Trials

Research summary · Randomized human trials · Published 2006

An independent educational summary of two randomized, placebo-controlled early-phase trials of an investigational CJC-1295 DAC preparation in healthy adults. Reported here for what it did and did not measure — not as medical advice, dosing guidance, or an endorsement of human use.

Participants

66 healthy adults

Across two trials: 42 in a single-dose study and 24 in a multiple-dose study.

Design

Randomized, blinded

Double-blind, placebo-controlled, ascending-dose. Subcutaneous administration.

Follow-up

28 and 49 days

Short observation windows focused on drug and hormone concentrations.

Efficacy measured

None

No clinical outcomes assessed. Pharmacokinetics and hormone levels only.

Neutral, research-use-only reference articles on peptide classification, structure, and analytical documentation. These articles summarize independently published third-party literature. The studies and their authors are not affiliated with, sponsored by, or endorsed by Ovrform, and nothing here describes or implies any use of Ovrform products.

Key Takeaway

Prolonged pharmacological activity, no clinical outcomes

Two early-phase, randomized, placebo-controlled trials found that a long-acting form of CJC-1295 produced sustained increases in circulating growth hormone, or GH, and insulin-like growth factor 1, or IGF-1, in healthy adults. Following a single administration, mean GH concentrations remained elevated for at least six days, while mean IGF-1 concentrations remained elevated for approximately nine to eleven days. Repeated administration produced evidence of drug accumulation and maintained mean IGF-1 above baseline through the study’s 28-day measurement period.

No serious adverse reactions were reported in these two trials. However, non-serious adverse events were common — particularly injection-site reactions, headache, gastrointestinal symptoms, flushing and transient reductions in blood pressure. The trials were small, short and designed primarily to study pharmacokinetics and hormone responses, not clinical benefits or long-term safety.

The results therefore demonstrate a prolonged biological effect on the GH/IGF-1 axis. They do not establish that CJC-1295 improves body composition, muscle growth, fat loss, recovery, sleep, athletic performance, aging outcomes or any medical condition.

01 · Study Identification

Study identification

Original study

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. The Journal of Clinical Endocrinology & Metabolism. March 2006;91(3):799–805.

PMID

16352683

DOI

10.1210/jc.2005-1536

Study type

Two randomized, double-blind, placebo-controlled, ascending-dose trials

Population

Healthy adults between 21 and 61 years of age

Published

J Clin Endocrinol Metab, March 2006;91(3):799–805

Objectives

Pharmacokinetics, hormonal effects and short-term tolerability of CJC-1295

02 · Product Identity

Important product-identity note

The term CJC-1295 is used inconsistently in scientific and commercial sources. It may refer to chemically distinct substances, including:

The publication referred to the investigational substance as both CJC-1295 and DAC-GRF and provided a structure corresponding to the CJC-1295 DAC active moiety. FDA subsequently concluded that the study appears to have used CJC-1295 DAC, but that the publication did not identify the associated salt form.

The findings should therefore be described as evidence concerning an investigational CJC-1295 DAC preparation manufactured by ConjuChem, not as evidence for every substance sold or labeled simply as “CJC-1295.”

03 · At a Glance

Study at a glance

Study characteristic	Description
Number of trials	Two
Total enrollment	66 healthy adults
Study 1	42 participants in a single-dose trial
Study 1 allocation	35 received CJC-1295 DAC and 7 received placebo
Study 2	24 participants in a multiple-dose trial
Study 2 allocation	20 received CJC-1295 DAC and 4 received placebo
Design	Randomized, double-blind, placebo-controlled and dose escalating
Route studied	Subcutaneous administration
Single-dose range	30, 60, 125 or 250 micrograms per kilogram
Multiple-dose protocols	Two or three administrations given at weekly or two-week intervals
Trial durations	28 days and 49 days
Main measurements	CJC-1295 concentrations, GH, IGF-1, adverse events, laboratory testing and electrocardiographic findings
Clinical outcomes tested	None
Long-term treatment tested	No

Protocol information is presented solely to describe the published research design. It is not dosing or administration guidance.

04 · Methods

What the researchers studied

The investigators conducted two separate trials at two investigational sites.

Study 1: Single-dose trial

The single-dose trial included four initial dose-escalation groups. In each group, five participants received the investigational substance and one received placebo. The active-treatment groups received one of four ascending amounts. An additional group of 18 participants was evaluated at one of the intermediate amounts, with 15 receiving active treatment and three receiving placebo.

Participants were monitored for approximately 28 days. The investigators measured:

Study 2: Multiple-dose trial

The multiple-dose trial included 24 participants divided among four sequential groups. Each group contained five active-treatment participants and one placebo participant. Depending on the group, participants received either two administrations separated by two weeks or three administrations separated by one week. Participants were monitored for approximately 49 days.

This second trial was intended to determine whether repeated exposure produced accumulation of the investigational substance or progressively greater hormonal effects.

05 · Findings

What the study observed

Pharmacokinetics

After a single administration, maximum measured concentrations of the investigational substance generally occurred approximately one to one and a half hours later. The estimated mean elimination half-life was approximately 5.8 to 8.1 days in the single-dose trial.

FDA’s later analysis of both trials reported estimates ranging approximately from 5.4 to 9.2 days, depending on the group and available sampling. Measurable concentrations remained present for approximately 10 to 13 days following single or repeated exposure.

Growth hormone response

A single administration produced dose-dependent increases in mean GH concentrations. Mean GH increased approximately twofold to tenfold and remained elevated for six days or longer. Hormone exposure over the seven-day measurement period was significantly greater than placebo in the 60, 125 and 250 microgram-per-kilogram groups.

Peak GH concentrations usually occurred during the first several hours, although there was substantial variability among participants.

IGF-1 response

Mean IGF-1 concentrations increased approximately 1.5-fold to threefold after a single administration and remained elevated for approximately nine to eleven days. The time to maximum IGF-1 concentration was delayed relative to the GH response — peak IGF-1 generally occurred two to three days after the lower amounts and approximately four days after the highest amount.

At the highest single amount studied, mean IGF-1 exceeded the applicable age- and sex-adjusted reference range. Mean IGF-1 remained elevated for at least two weeks in participants who received the two highest single amounts.

Effects of repeated exposure

In the multiple-dose trial, mean IGF-1 began increasing within approximately eight hours and remained above baseline through day 28. Maximum concentrations and total exposure to the investigational substance were higher after subsequent administrations, and maximum IGF-1 responses became progressively greater, indicating a cumulative pharmacological effect.

Elevated GH and IGF-1 levels were still present before later administrations in many participants, reflecting the prolonged activity of the DAC-modified molecule.

06 · Adverse Events

Reported adverse events

The absence of serious adverse reactions should not be interpreted as an absence of adverse effects. Non-serious adverse events were frequently reported.

Single-dose trial · Active

94%

33 of 35 active-treatment participants reported at least one adverse event.

Single-dose trial · Placebo

29%

2 of 7 placebo participants reported at least one adverse event.

Single-dose trial

Injection-site irritation, redness, hardening, pain or itching in approximately 70% of active-treatment participants
Transient localized urticarial rashes in almost 30%
Headache in 63% of active-treatment participants and 14% of placebo participants
Diarrhea in 43% of active-treatment participants
Flushing, warmth or transient hypotension in approximately 30% of active-treatment participants
More frequent or prolonged reactions at the two highest amounts studied

Loose stools or diarrhea were particularly frequent in the two highest dose groups.

Multiple-dose trial

Injection-site reactions were reported in every active-treatment participant in the multiple-dose study. Mild injection-site reactions were also observed in several placebo participants. Additional reported events included:

Flushing, with a reported incidence ranging from 40% after lower exposures to 100% after higher exposures
Headache
Nausea or abdominal pain
Transient dizziness and hypotension in two participants
Transient involuntary leg-muscle contractions and some loss of coordination in one participant
Localized redness, itching, pain or hardening

The flushing generally began within approximately 30 minutes and resolved within one to two hours.

Laboratory and cardiac monitoring

The authors reported no consistent treatment-associated changes in blood or urine laboratory values, blood glucose, liver-function testing or electrocardiographic findings. No serious adverse reactions were reported in either published trial — but the studies were not large or long enough to reliably identify uncommon, delayed or cumulative adverse effects.

07 · Immunogenicity

Antibody testing

The investigators reported that no significant antibody formation was detected in participants who received active treatment.

This finding requires qualification. Most active-treatment participants received only one exposure, the publication did not provide detailed information about the assay’s sensitivity or validation, and short-term negative antibody testing cannot exclude immunogenicity after longer or repeated exposure.

FDA has also noted that injectable peptides may present immunogenicity risks associated with aggregation, impurities, manufacturing conditions and similarities to endogenous human peptides.

08 · Interpretation

How the findings should be interpreted

The most supportable interpretation is:

In two early-phase trials, an investigational CJC-1295 DAC preparation produced prolonged and dose-dependent increases in GH and IGF-1 in healthy adults. No serious adverse reactions were reported during the limited observation periods, but non-serious adverse events — particularly injection-site reactions, headache, gastrointestinal symptoms and systemic vasodilatory symptoms — were common.

The findings demonstrate pharmacological activity. They do not demonstrate a favorable benefit-risk balance for any medical or nonmedical purpose. This research did not establish that CJC-1295:

Increases muscle mass
Causes weight loss
Accelerates exercise or injury recovery
Increases energy
Treats growth-hormone deficiency
Is safe for long-term or repeated use
Has the same effects without the DAC modification

Reduces body fat
Improves athletic performance
Improves sleep
Reverses or slows aging
Treats HIV-associated lipodystrophy
Is safe in people with cardiovascular, metabolic, endocrine or oncologic conditions
Validates the identity, quality or safety of products from other sources

The study measured circulating drug and hormone concentrations. It did not measure changes in lean mass, fat mass, strength, physical performance, healing, height, quality of life or other patient-centered outcomes. FDA therefore concluded that the available healthy-adult studies do not establish effectiveness for growth-hormone deficiency.

09 · Strengths

Study strengths

The study had several methodological strengths for an early pharmacology investigation:

These design features support the conclusion that the investigational product caused the observed changes in GH and IGF-1.

10 · Limitations

Important limitations

Small treatment groups

Although 66 people participated across the two trials, individual dose groups were small. Most cohorts contained only five active-treatment participants.

Small cohorts cannot reliably estimate the incidence of uncommon adverse effects or meaningfully compare safety between amounts.

Short follow-up

The trials lasted 28 and 49 days, and most participants received only one administration.

The research could not evaluate long-term metabolic effects, cumulative fluid retention, persistent glucose changes, sustained cardiovascular effects, delayed immune reactions, reproductive or developmental effects, long-term pituitary effects or cancer-related outcomes.

Healthy participants only

The participants were healthy adults with functioning hypothalamic-pituitary systems. Results may differ in people with partial or complete growth-hormone deficiency, endocrine disease, cardiovascular disease, diabetes or other medical conditions.

A person with complete growth-hormone deficiency may not respond in the same way, because CJC-1295 depends on the pituitary gland’s remaining capacity to secrete endogenous GH.

Pharmacological — not clinical — endpoints

Increasing GH or IGF-1 is a laboratory outcome. It is not itself proof of improved health, physical performance, recovery or body composition.

The trial did not determine whether the measured hormone changes produced a net clinical benefit.

Frequent adverse events

Although the authors characterized the investigational substance as relatively well tolerated at lower amounts, 94% of active-treatment participants in the single-dose study reported at least one adverse event. Injection-site reactions, headaches and other symptoms were substantially more common than with placebo.

The phrase “no serious adverse reactions” should therefore not be paraphrased as “no side effects” or “proven safe.”

Limited statistical power for safety

The study was designed principally to characterize drug concentrations and hormone responses. It was not powered to establish general safety or to detect rare events.

Product-identity uncertainty

The publication appears to concern CJC-1295 DAC, but it does not clearly identify the salt form. The study cannot be extrapolated to CJC-1295 without DAC, modified GRF 1-29, CJC-1295 acetate without DAC, blends containing ipamorelin or other peptides, or products with different manufacturing, purity, aggregation, sterility or impurity profiles.

FDA has specifically warned that inconsistent CJC-1295 naming creates a risk that materially different substances may be confused with one another.

Limited antibody evaluation

The reported absence of significant antibody formation came primarily from participants with one or a few exposures. The antibody assay was not described sufficiently to exclude immunogenicity during longer-term treatment.

Sponsor and author context

The investigational substance was manufactured by ConjuChem, the company developing CJC-1295. Three of the six authors were affiliated with ConjuChem, two with WinPharm Associates and one with the University of Illinois.

These affiliations do not invalidate the results, but they are relevant when evaluating the study’s favorable interpretation and its statement concerning potential therapeutic utility. Independent replication and longer-term trials would be needed to confirm the findings.

11 · Broader Context

Broader safety context

The published trials reported no serious adverse reactions, but subsequent development did not produce sufficient evidence to establish long-term safety or clinical effectiveness.

In its 2024 review, FDA described anecdotal reports from a separate, unpublished Phase 2 trial involving 192 participants with HIV-associated lipodystrophy. One participant developed chest discomfort approximately two hours after an eleventh weekly administration, experienced an acute myocardial infarction and died. The attending physician reportedly considered previously asymptomatic coronary artery disease with plaque rupture and occlusion to be the most likely explanation.

The Phase 2 trial was terminated, and its complete results were not published. The available information does not establish that CJC-1295 caused the event, but it also does not allow a complete independent assessment of causality or the other participants’ safety outcomes.

Hormonal-axis considerations

Because CJC-1295 DAC stimulates endogenous GH and consequently increases IGF-1, potential risks associated with sustained activation of the GH/IGF-1 axis require consideration. FDA has noted that approved recombinant GH products carry warnings or precautions involving matters such as:

This does not prove that CJC-1295 has an identical risk profile. Rather, FDA concluded that the available evidence is insufficient to determine that substances stimulating the GH/IGF-1 axis would be free from similar concerns.

12 · Regulatory

Regulatory context

CJC-1295 is not the active ingredient in an FDA-approved drug product. FDA’s December 2024 evaluation recommended against including the evaluated CJC-1295 forms on the Section 503A bulk drug substances list. FDA cited concerns including:

FDA’s public safety-risk resource continues to state that available clinical data for CJC-1295 are limited and identifies increased heart rate and systemic vasodilatory reactions among the serious safety concerns associated with its use.

Regulatory information last reviewed: July 30, 2026. Regulatory classifications and agency policies can change and should be rechecked before publication. See the FDA Disclaimer.

Conclusion

Overall conclusion

The 2006 Teichman study provides evidence that an investigational CJC-1295 DAC preparation can substantially and persistently stimulate the GH/IGF-1 axis in healthy adults. Its strongest findings concern pharmacokinetics and hormone concentrations:

The study did not demonstrate clinical effectiveness for any condition or wellness objective. Non-serious adverse events were common, the treatment groups were small, follow-up was short and long-term risks were not evaluated.

Accordingly, this publication should be treated as early human pharmacology evidence — not as proof of therapeutic benefit, general safety or equivalence between the investigational preparation and commercially available research materials.

Editorial Disclaimer

This page is an independent educational summary of third-party scientific research. It is not medical advice, a treatment recommendation or an endorsement of CJC-1295 for human use.

Descriptions of amounts, timing and administration routes are included solely to report the published experimental methods. They should not be interpreted as instructions.

The investigational substance was manufactured for the original developer and was not supplied by Ovrform. The study does not establish the identity, purity, potency, sterility, safety, effectiveness or regulatory status of any material sold by Ovrform or another supplier. The terms CJC-1295, CJC-1295 DAC and CJC-1295 without DAC should not be treated as interchangeable. See the Research Use Only Policy.

References

1. Teichman SL, Neale A, Lawrence B, Gagnon C, Castaigne JP, Frohman LA. Prolonged stimulation of growth hormone and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of growth hormone-releasing hormone, in healthy adults. J Clin Endocrinol Metab. 2006;91(3):799–805. DOI: 10.1210/jc.2005-1536. PMID: 16352683.

2. U.S. Food and Drug Administration. Pharmacy Compounding Advisory Committee Briefing Document: CJC-1295-Related Bulk Drug Substances. December 4, 2024.

3. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks.

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