Peptide Graded

Tesamorelin

Does Tesamorelin work?

Partly: some human trials, with gaps. Trials of 806 people with HIV; one of 60 without.

BSome human evidenceFDA approvedas of 2026-10-26

Two phase 3 randomized trials in HIV-associated abdominal fat, pooled at 806 patients, support the approved indication, which would be A for that use. The use tesamorelin is best known for outside clinics, trimming visceral fat in people without HIV, rests on one 60-person randomized trial in obese adults with reduced growth hormone and one 61-person trial in HIV-related fatty liver, so the popular use grades B. 27810

The first phase 3 trial was published in the New England Journal of Medicine in 2007. It randomized 412 adults with HIV and abdominal fat buildup to tesamorelin or placebo for 26 weeks. Visceral fat on CT fell 15.2 percent on tesamorelin and rose 5 percent on placebo. Triglycerides and the total-to-HDL cholesterol ratio improved. Glucose measures did not change. 9

A second phase 3 trial had 404 patients. A pooled analysis of both trials (806 randomized, 543 on tesamorelin) confirmed a treatment effect of about 15 percent on visceral fat at 26 weeks. Subcutaneous fat did not change. Patients rated their belly appearance as better. Patients who continued to 52 weeks kept about an 18 percent reduction. Those switched to placebo lost the benefit within six months. 21011

Evidence checklist

  • Randomised controlled trial Two phase 3 RCTs; two small RCTs
  • Human study over 100 people Phase 3 trials pooled 806 patients
  • More than one research group Article does not say who ran the trials
  • Clinical outcomes, not surrogate markers Visceral fat and liver fat measured
  • Human safety data beyond case reports Phase 3 safety data; IGF-1 monitoring advised

Read the full Tesamorelin page

More on Tesamorelin

Citations

  1. DailyMed: Egrifta (tesamorelin) prescribing information dailymed.nlm.nih.gov
  2. Falutz 2010, JAIDS: Tesamorelin in HIV-infected patients with abdominal fat accumulation, randomized trial with safety extension doi.org
  3. DailyMed: Egrifta WR (tesamorelin) prescribing information dailymed.nlm.nih.gov
  4. Falutz 2008, AIDS: Long-term safety and effects of tesamorelin, 52-week extension doi.org
  5. Falutz 2010, JAIDS: Effects on visceral adipose tissue doi.org
  6. FDA 2025: Egrifta prescribing information (NDA 022505) accessdata.fda.gov
  7. Stanley 2012, J Clin Endocrinol Metab: Metabolic effects of a GHRH analog in obese subjects with reduced GH secretion, randomized controlled trial pubmed.ncbi.nlm.nih.gov
  8. Stanley 2019, Lancet HIV: Effects of tesamorelin on non-alcoholic fatty liver disease in HIV, randomized trial pubmed.ncbi.nlm.nih.gov
  9. Falutz 2007, NEJM: Metabolic effects of a growth hormone-releasing factor in patients with HIV pubmed.ncbi.nlm.nih.gov
  10. Falutz 2010, J Clin Endocrinol Metab: Pooled analysis of two phase 3 tesamorelin trials pubmed.ncbi.nlm.nih.gov
  11. Falutz 2010, JAIDS: Tesamorelin in HIV with abdominal fat, randomized trial with safety extension pubmed.ncbi.nlm.nih.gov
  12. Clemmons 2017, PLoS One: Safety and metabolic effects of tesamorelin in type 2 diabetes, randomized trial pubmed.ncbi.nlm.nih.gov
  13. DailyMed: Egrifta label, warnings on glucose dailymed.nlm.nih.gov
  14. Ferdinandi 2007, Basic Clin Pharmacol Toxicol: Non-clinical pharmacology and safety of TH9507 pubmed.ncbi.nlm.nih.gov

Reference information only, not medical advice. Drawn from the Tesamorelin article, fact-checked against the cited sources. No dosing anywhere on this site.