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 lab-made version of growth hormone-releasing hormone (GHRH). GHRH has 44 amino acids. The hypothalamus sends it to the pituitary as a signal to release growth hormone. Tesamorelin has a small chemical group (trans-3-hexenoyl) on its first amino acid. This protects the peptide from the enzyme DPP-4. It lets the peptide last long enough in the blood to work as an injection. ¹⁴

Theratechnologies developed it under the code TH9507. It treats HIV-associated lipodystrophy. This is a pattern of fat shifting that older antiretroviral drugs caused. Fat builds up deep in the abdomen. The FDA approved it as Egrifta in 2010. A more concentrated Egrifta SV followed. In 2025, the FDA approved Egrifta WR, a weekly-reconstitution form. ¹³⁶

How it works

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

What human research shows

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

Outside HIV, one 12-month randomized trial studied 60 adults with belly obesity and low growth hormone secretion. Visceral fat fell on tesamorelin and rose on placebo. Triglycerides, C-reactive protein and carotid artery wall thickness improved. Glucose did not change. A trial in 61 people with HIV and fatty liver found liver fat dropped 37 percent relative to baseline. A trial in 53 patients with type 2 diabetes found no worse blood sugar 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

The most common side effects in the phase 3 trials were injection-site reactions (redness, itching, pain), joint pain, swollen limbs, muscle aches and tingling. More patients on tesamorelin than on placebo quit because of adverse events. IGF-1 rises substantially. The label advises monitoring it, because long-lasting high IGF-1 is linked to cancer risk in other settings. ¹⁹¹⁰

The label lists contraindications for pregnancy, active cancer, and damage to the pituitary-hypothalamic axis from surgery, tumor or radiation. Glucose was unchanged in the trials. Still, the label flags that tesamorelin can raise blood sugar and advises checking it. The trial that included people with diabetes excluded those with poorly controlled disease. No one has studied long-term heart outcomes. No trial has tested tesamorelin in healthy people who want 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 extra belly fat in adults with HIV who have lipodystrophy. That is the only FDA-approved use across all three Egrifta forms. Using it 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 reduction in visceral fat was about 15 percent at 26 weeks. 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 researchers watched this closely. The HIV phase 3 trials and a 12-week trial in people with type 2 diabetes found no difference from placebo in fasting glucose and HbA1c. 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 has the full 44 amino acids, plus a chemical change that resists breakdown by DPP-4. This gives 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 next 26 weeks. Patients must keep taking the drug for the effect to last. 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