Tesamorelin. What is it? Why do people take it? What the studies show.

What is Tesamorelin?

Tesamorelin is a synthetic analog of human growth hormone releasing hormone (GHRH). It stimulates your pitutary gland to release your body’s growth hormone. It is FDA approved. Its approval was for HIV infected adults who had excess visceral (intra-abdominal) fat.

How does Tesamorelin work?

Tesamorelin binds to growth hormone receptors in the pituitary, which causes your body to release growth hormone in a pulsatile fashion- just like your body would do it naturally. Growth hormone then does the rest. Growth hormone has an anabolic effect, and helps break up fat in fat cells, the liver, muscle cells, and other areas which are affected by IGF-1.

It does NOT significantly change other pituitary hormones, like thyroid, prolactin, luteinizing hormone, and ACTH.

Who is a candidate?

This medication was studied primarily in HIV positive patients. The approved dose is 1.4 mg injected subcutaneously into the abdomen, once a day.

What are the medical benefits of tesamorelin?

The giant buzz about Tesamorelin is that it reduces intraabdominal, “visceral” fat, which is the fat associated with metabolic syndrome. Particularly for middle aged men and menopausal women, fat starts to accumulate internally as we age. Fatty liver is also an issue for many, which can lead to liver disease, and eventually cirrhosis. Fatty liver can be caused by alcohol use, but NAFLD (non-alcoholic fatty liver disease) and MASH (metabolic dysfunction associated Steatohepatitis) is common in patients who are overweight or pre/diabetic. Blogs on fatty liver

It is NOT indicated for general weight loss (but the GLPs are great for that!). Long term heart effects have not been established.

STUDIES:

• Visceral fat reduction: Two phase 3 studies (with 800 patients) showed tesamorelin reduced visceral fat by 14-18% over 26 weeks vs placebo. Note: it was maintained through 52 weeks but reversed when the medication was stopped.
• Fatty liver: A randomized trial of NAFLD showed 37% relative reduction vs placebo, with 35% of tesamorelin patients achieving resolution of steatosis (HFF <5%) versus 4% on placebo. Tesamorelin improved inflammatory liver markers.
• Metabolic improvements: Significant improvements in triglycerides, adiponectin, and glucose homeostasis over 52 weeks in “responders”.
• In low growth hormone secreters (non-HIV obese subjects) tesamorelin reduced visceral fat, triglycerides, C-reactive protein, and carotid intima-media thickness.
• Body image: Improvements in trunk fat, waist circumference, and patient-reported body image distress were observed.

What is the negative of Tesamorelin? Risk?

As with all medications, there are common small reactions: muscle aches, injection site reactions, pain, swelling. Serious issues were <4%. But there are contraindications.

• Blood sugar issues. Are you glucose intolerant? Have diabetes? 5% of patients on tesamorelin developed a HBA1c over 6.5.
• Elevated IGF-1 in 47% of patients
• CANCER RISK. Growth hormone is a growth factor. If you have a history of cancer, you should not take a medication which stimulates growth hormone.
• Fluid retention. This can lead to swelling, muscle aches, and carpal tunnel.
• Increase mortality in acute critical illness. If you are very sick with another illness, you should not take this medication.
• Pregnancy. Animal studies have shown hydrocephaly in the offspring of experimental animals.

What is the future of Tesamorelin?

Off label interest is growing for non-HIV populations. The benefits seen in visceral fat and fatty liver are solid, but will these apply to all patient categories?

There is age related decline in how much growth hormone you produce.  (Some call this “somatopause.”) This decline causes loss of lean muscle, increased visceral fat, and cognitive decline. As Tesamorelin stimulates the pituitary to make a normal, pulsatile release of growth hormone, preliminary studies suggest it may help improve all those issues. But clinical trials and endpoints are still not known.

What do we think at Biohackr Health?

You need to come into a Biohackr Health clinic to discuss. We do offer some peptides. The key to all of this is to tailor what you do to YOU. What are you treating? Do you have any other medical issues? What is the endpoint? What is your risk profile? Risk tolerance? Many new and regenerative treatments can stimulate growth in unintended ways (like cancer).

There is not a black and white answer.

We also know GLPs can help with weight loss and fatty liver. Blood sugar control may lower your risk for many issues. So when evaluating what approach to do, we want to look at the big picture.

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