Tesamorelin

Why scientists study it

• The FDA approved it for one use, HIV-related lipodystrophy, and its large human safety record covers more than 800 Phase 3 subjects plus groups followed for years.
• Beyond that use, scientists test it for deep belly fat, fatty liver (NAFLD) markers, liver scarring, and age-related decline in thinking skills in adults with HIV.
• It switches on the GHRH receptor in the pituitary, so the body releases its own growth hormone in pulses and the brain’s feedback control stays in place.

Three studies to know

2007 · New England Journal of Medicine

Falutz and colleagues ran the main Phase 3 trial in 412 HIV-infected patients with fat buildup around the middle. Over 26 weeks, deep belly fat on CT scans fell 15.2% with tesamorelin and rose 5.0% with placebo. Triglycerides and adiponectin also moved in a good direction. Read the paper

2014 · JAMA

Stanley and colleagues gave tesamorelin or placebo to 50 HIV-infected adults with fat buildup around the middle for 6 months. Liver fat on proton MR spectroscopy dropped 2.9% in absolute terms compared with placebo. Deep belly fat fell too, as expected. Read the paper

2011 · Drugs

Dhillon reviewed the Phase 3 data behind the FDA approval for HIV-related lipodystrophy. The review covers how the drug acts, its effect on deep belly fat, how well people tolerated it, and the need for IGF-1 checks. Read the paper

Safety and legal status

• It has a large human safety record. Common effects are injection-site reactions, a rise in IGF-1 that needs regular checks, and a modest rise in blood sugar in people prone to it.
• The FDA approved it in 2010 as Egrifta, and Health Canada in 2014, for HIV-related lipodystrophy only. The MHRA and the EMA have not approved it. The World Anti-Doping Agency bans it in and out of competition (class S2).
• Research supply is for laboratory and in vitro use only. It is not meant for human use.