Tesamorelin: evidence, FDA status and research

It is a shot that cuts belly fat in people with HIV. It cut deep belly fat about 15% in six months, but the fat returned after stopping, and outside HIV there is one trial of 60 people.

Sold for

Tesamorelin is marketed by longevity and body-composition clinics as a growth-hormone-releasing injection that melts belly fat without the risks of growth hormone itself.

Studies say

In people with HIV it reliably cuts visceral fat by about 15 percent over six months, but the fat returns when the drug stops and the evidence in people without HIV is a single small trial, which is the logic of the B grade.

Why grade B. 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

FDA. Tesamorelin is approved by the FDA as Egrifta (2010), Egrifta SV, and Egrifta WR (2025) to reduce excess abdominal fat in adults with HIV and lipodystrophy. It is not approved for weight loss, fat loss in people without HIV, or anti-aging. ¹³⁶

Written from 14 cited sources. Last refreshed 2026-10-27. Not physician reviewed.

What this means for you

What people take it for: Belly fat in people with HIV; online, fat loss and anti-aging
Can a US doctor prescribe it?: Yes, FDA approved for belly fat in adults with HIV.
Properly tested in people?: Partly: some human trials, with gaps. Trials of 806 people with HIV; one of 60 without.

Evidence checklist

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

Drawn from the cited studies below. A dash means the sources give no information.

What it is

Tesamorelin is a synthetic version of growth hormone-releasing hormone (GHRH), the 44-amino-acid signal the hypothalamus sends to the pituitary to release growth hormone. A small chemical group (trans-3-hexenoyl) is attached to the first amino acid, which protects the peptide from the enzyme DPP-4 and lets it last long enough in the blood to work as an injection. ¹⁴

Theratechnologies developed it under the code TH9507 for HIV-associated lipodystrophy, a pattern of fat redistribution seen with older antiretroviral drugs where fat builds up deep in the abdomen. The FDA approved it as Egrifta in 2010; a more concentrated Egrifta SV followed, and Egrifta WR, a weekly-reconstitution formulation, was approved in 2025. ¹³⁶

How it works

Tesamorelin binds GHRH receptors on the pituitary and triggers pulses of the body's own growth hormone, which in turn raises IGF-1 (insulin-like growth factor 1) in the liver. Growth hormone is lipolytic, meaning it breaks down stored fat, and visceral fat is more sensitive to it than fat under the skin. Because the pituitary's own feedback loop stays intact, growth hormone pulses stay closer to a physiological pattern than with injected growth hormone. ¹¹⁴

What human research shows

The first phase 3 trial, published in the New England Journal of Medicine in 2007, randomized 412 adults with HIV and abdominal fat accumulation 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 of 404 patients and a pooled analysis of both (806 randomized, 543 on tesamorelin) confirmed a treatment effect of about 15 percent on visceral fat at 26 weeks, with no change in subcutaneous fat and improved patient-rated belly appearance. Patients who continued to 52 weeks held about an 18 percent reduction; those switched to placebo lost the benefit within six months. ²¹⁰¹¹

Outside HIV, one 12-month randomized trial in 60 abdominally obese adults with reduced growth hormone secretion found visceral fat fell on tesamorelin while rising on placebo, with improvements in triglycerides, C-reactive protein and carotid artery wall thickness, and no change in glucose. A 61-patient trial in people with HIV and fatty liver found liver fat dropped 37 percent relative to baseline. A 53-patient trial in type 2 diabetes found no worsening of glycemic control over 12 weeks. ⁷⁸¹²

Study	Model	Finding
Falutz 2007 phase 3 (NEJM)	Humans with HIV, n=412, randomized placebo-controlled, 26 weeks	Visceral fat fell 15.2 percent on tesamorelin and rose 5 percent on placebo; lipids improved and glucose did not change. ⁹
Pooled phase 3 analysis (Falutz 2010)	Humans with HIV, n=806, two randomized placebo-controlled trials with 52-week extension	Treatment effect of about 15 percent on visceral fat at 26 weeks, maintained at 52 weeks in those who continued, with no change in subcutaneous fat. ¹⁰
Stanley 2012 (JCEM)	Humans without HIV, n=60 obese adults with reduced GH secretion, randomized placebo-controlled, 12 months	Visceral fat, triglycerides, C-reactive protein and carotid intima-media thickness improved versus placebo without a change in glucose. ⁷
Stanley 2019 (Lancet HIV)	Humans with HIV and fatty liver, n=61, randomized placebo-controlled, 12 months	Liver fat fell 37 percent relative to baseline versus placebo, with 35 percent of treated patients reaching normal liver fat. ⁸
Clemmons 2017 (PLoS One)	Humans with type 2 diabetes, n=53, randomized placebo-controlled, 12 weeks	No difference in insulin response, fasting glucose or HbA1c between tesamorelin and placebo. ¹²

Safety

Injection-site reactions (redness, itching, pain), joint pain, swelling in the limbs, muscle aches and tingling were the most common side effects in the phase 3 trials, and more tesamorelin than placebo patients withdrew for adverse events. IGF-1 rises substantially, and the label advises monitoring it because sustained high IGF-1 is linked to cancer risk in other settings. ¹⁹¹⁰

The label lists contraindications for pregnancy, active cancer, and disruption of the pituitary-hypothalamic axis from surgery, tumor or radiation. Glucose was unchanged in the trials, but the label flags that tesamorelin can raise blood sugar and advises checking it, and the trial that included diabetics excluded those with poorly controlled disease. Long-term cardiovascular outcomes have not been studied, and no trial has tested tesamorelin in healthy people seeking cosmetic fat loss. ¹¹²¹³

Questions for your clinician

Is there a controlled trial for people without HIV beyond one 60-person study?
What happens to the fat when I stop?
How will IGF-1 be monitored?

Questions people ask

What is tesamorelin approved for?

Reducing excess abdominal fat in adults with HIV who have lipodystrophy. That is the only FDA-approved indication across all three Egrifta formulations. Use for weight loss or body composition in people without HIV is off-label. ¹⁶

How long does tesamorelin take to reduce visceral fat?

In the phase 3 trials, the roughly 15 percent reduction in visceral fat was measured at 26 weeks, and continuing to 52 weeks brought it to about 18 percent. The effect reversed within six months in patients switched to placebo. ¹⁰¹¹

Does tesamorelin raise blood sugar?

Growth hormone can cause insulin resistance, so this was watched closely. In the HIV phase 3 trials and a 12-week trial in people with type 2 diabetes, fasting glucose and HbA1c did not differ from placebo. The label still advises monitoring glucose. ⁹¹²¹³

How is tesamorelin different from sermorelin?

Both are GHRH analogs. Sermorelin copies the first 29 amino acids of GHRH; tesamorelin is the full 44-amino-acid sequence with a chemical modification that resists breakdown by DPP-4, giving it a longer action. Tesamorelin has FDA approval and phase 3 trials; sermorelin's approval was withdrawn and it is now compounded. ¹⁴

Does the fat come back after stopping?

Yes. In the extension phase of the phase 3 program, patients re-randomized from tesamorelin to placebo lost their visceral fat reduction over the following 26 weeks. The drug has to be continued for the effect to persist. ¹⁰¹¹

Citations

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