We are still in the “Substance” world of peptides and this week CJC-1295 and Ipamorelin are in the spotlight.

When I first started going to functional medicine courses over 20 years ago, growth hormone was all the rage.  You could spot the people, mainly men, taking them not only because of their increased muscle mass at an older age but eventually they got an unusual what I thought of a waxy, chiseled feature (not in a good way) to their face the longer they were on them.  The FDA raided several clinics promoting these and created specific guidelines and testing on who should get growth hormone.  To understand the FDA actions and to understand the drugs in this newsletter you need to have a basic understanding about growth hormone.

Growth hormone (GH) is literally what it says – it is a hormone that promotes growth.  We produce it in the pituitary gland and release it in a controlled manor.  GH has these actions:

  • Growth – Stimulates bone growth and remodeling of bone
  • Bone density – in adults, physiologic doses help maintain bone density
  • Metabolism – promotes fat breakdown, increases protein synthesis and can raise blood sugar levels
  • Muscle – supports muscle mass and growth, helps with tissue repair

Too much growth hormone can cause gigantism in children and acromegaly in adults.  Acromegaly consists of enlargement of hands, feet, face and internal organs and can cause some serious health issues.  Thickened skin, joint pain, sleep apnea, fatigue, cardiovascular changes including high blood pressure and heart failure, diabetes, higher cancer risks as well as deepening voice are all effects of too much GH.  Naturally occurring overproduction of GH is typically due to a pituitary tumor which requires treatment to lower the levels.

When repleting GH in individuals who are deficient based on testing, long-term use is generally considered safe provided they follow the proper dosing schedules and guidelines.

As we age GH, naturally declines, so the million-dollar question is how much GH is an optimal level for anti-aging when testing is in normal ranges.  I can tell you right now, I am not going to be able to answer that question because there are not any studies looking at what an optimal level should be for anti-aging benefits.  However, these peptides are available and you need to know what they are doing.  READ ON to learn more about these substances…

Growth hormone and growth hormone analogs has been around since the 1950’s and the safer synthetic version introduced in the 1980’s.  There are several FDA approved medications:

  • Somatropin (human growth hormone)– approved for children and adults with proven growth hormone deficiencies, HIV induced wasting and short-bowel syndrome
  • Sermorelin (growth hormone-releasing hormone analog) FDA approved for children with growth hormone deficiencies.
  • Tesamorelin (growth hormone-releasing hormone analog) approved for reducing visceral fat in HIV patients.

Since you now have all the backstory on growth hormone let’s look at our featured substances:

CJC-1295 – is a Growth Hormone-Releasing Hormone analog which means CJC-1295 mimics growth hormone-releasing hormone stimulating the pituitary gland to release GH.   It differs from actual GH in that it provides a more sustained signal than the current GH analogs available.  The peptide world touts it for improved physical performance, increased muscle mass, fat burning, improved bone density and cognition. It is banned in sports.

Ipamorelin acts like Ghrelin.  Ghrelin is a hormone that is sometimes referred to as the “hunger hormone” and is produced in the stomach signaling the brain to increase the appetite so you will eat.  It plays a role in fat storage, energy and GH release.  Ipamorelin triggers the release of GH but is shorter acting.  However, unlike Ghrelin, it does so without increasing cortisol or triggering the hunger response.  As a peptide, it is being promoted for improved sleep, faster recovery and fat loss.  Also banned in sports.

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CJC-1295 and Ipamorelin are paired together in some instances with the idea of achieving a rapid surge with the ipamorelin and a more sustained response with the CJC-1295.  The peptide world touts it for improved weight loss and maintenance of muscle mass, deeper sleep and higher GH release.

CJC with DAC – DAC is a drug affinity complex that increases the half-life of the CJC so it can be used once a week.

Now, after all of that.  Let’s look at the research.

CJC-1295 was actually part of a Phase 2 trial that was discontinued because of a death that occurred within a few hours of an injection later in the trial.  The trial was targeting HIV associated visceral obesity and was only a 12 week trial.   Investigators felt like the person that died may have had prior coronary artery disease that caused the death not related to the drug but the trial was ended anyway.  The Phase 1 trial leading to the second trial looked at dosing and the resulting levels of GH increase and was done in two segments.  One trial was 28 days and the other was 49 days.  Even in these shorter trials there was evidence there was a cumulative effect with continued dosing meaning the longer they were taking the drug the more GH was being made.

There are several human studies that are small and mainly looking at the degree of GH release with these drugs with different dosing intervals as discussed before.  Animal studies show promise of helping with GH deficiency stimulating bone growth and increased muscle mass.  There are no long-term studies (people or in animals) for anti-aging use in a population that is not growth hormone deficient.

Side-effects reported in the Phase 1 CJC 1295 trial included:

  • Injection side redness
  • Flu-like symptoms
  • Irritability
  • Anxiety
  • Nausea
  • Hives

Once again, long-term safety data in the aging population with normal growth hormone levels is missing.  Animal studies are short term and any human experience is in a short-term trial or uncontrolled clinical use.

Since the short-term trial demonstrated cumulative effects in only 11 weeks, there are concerns over longer term use and end points.  Combinations of these peptides are also missing long-term safety and efficacy trials in health and side-effects.  How these drugs affect cardiovascular health, cancer etc is unknown in someone with normal levels of GH and we do know the results of too much GH which makes this concerning.  How much is too much?

My take:  there is absolutely a role for growth hormone and the analogs in growth hormone deficient people.  Before starting any type of peptide that stimulates GH do some testing first to see if you are deficient because if you are there are FDA approved drugs available. There is significant concern over increasing cancer risk so if you have already had cancer then you need to discuss this with your physician before starting any of the GH stimulators.  Personally, I think the long-term use of these drugs should be considered only in special circumstances with eyes wide open.

To your health,

 

Laura