Peptide Graded

All peptides / Hormones

Tesamorelin (compounded)

GHRH analog

Also Compounded tesamorelin, Egrifta, Egrifta SV, Egrifta WR, TH9507, Tesamorelin acetate

Evidence
BSome human evidence
FDA status
Not approvedas of 2026-10-26
Route
Injection
Studies cited
7 human1 animal or cell

It is a shot sold by clinics to burn belly fat. It is approved only for people with HIV who have extra belly fat, and for others it rests on one trial of 60 people.

Sold for

Compounded tesamorelin is sold by longevity and body-composition clinics as the approved, cleaner alternative to CJC-1295 for burning visceral fat and raising growth hormone.

Studies say

It reliably cuts visceral fat by about 15% in HIV lipodystrophy, one 60-person trial suggests a similar selective effect in obese adults without HIV, and the fat returns within months of stopping, so the off-label use rests on a single small trial.

Why grade B. For the approved HIV indication the evidence would be A: two phase 3 placebo-controlled trials (412 and 404 patients, pooled 806) showed visceral fat fell about 15% over 26 weeks. For the use compounded tesamorelin is actually sold for, belly fat in people without HIV, there is one randomized trial of 60 abdominally obese adults with low GH secretion, and a 61-person trial in HIV-related fatty liver. That is B. 82967

FDA. Tesamorelin is FDA-approved as Egrifta (Egrifta SV, and since March 2025 Egrifta WR) only for reducing excess abdominal fat in adults with HIV who have lipodystrophy. Compounded tesamorelin sold for fat loss, muscle or anti-ageing in people without HIV is not an FDA-approved product and that use has no approved indication. 531

Written from 11 cited sources. Fact-checked 2026-10-27: 26 claims checked, 2 corrected. Last refreshed 2026-10-27. Not physician reviewed.

What this means for you

What people take it for
Burning belly fat and raising growth hormone
Can a US doctor prescribe it?
Yes, FDA approved for belly fat in adults with HIV; other uses are not approved.
Properly tested in people?
Partly: some human trials, with gaps. For people without HIV, one trial of 60 adults.

Evidence checklist

  • Randomised controlled trial Two phase 3 RCTs; 60-person trial without HIVyes
  • 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 measured, not health outcomesno
  • 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). It has the full 44-amino-acid sequence. A small chemical group at one end protects it from the enzyme DPP-IV. This stretches its action from minutes to long enough for a daily injection. Theratechnologies developed it as TH9507 and sells it as Egrifta. 111

The compounded version has the same active ingredient. A compounding pharmacy prepares it, not the maker. The FDA does not review compounded drugs for safety, effectiveness or quality. Federal law also limits compounding copies of approved drugs that are sold commercially. So a compounded tesamorelin prescription differs from the branded product in law and in quality, even when the molecule is identical. 15

How it works

Tesamorelin tells the pituitary to release growth hormone in its natural pulses. This raises IGF-1. Growth hormone is lipolytic, which means it drives fat cells to release stored fat. The deep belly (visceral) fat is unusually sensitive to it. In the trials, visceral fat fell while fat under the skin did not change. That selective effect is what the drug is prescribed for. 1119

What human research shows

The 2007 NEJM trial (412 patients) studied abdominal fat buildup linked to HIV. Over 26 weeks, visceral fat fell 15.2% on tesamorelin and rose 5.0% on placebo. Triglycerides and the cholesterol-to-HDL ratio also improved. A second trial of 404 patients and a pooled analysis of both (806 patients) gave a treatment effect of about -15.4% at 26 weeks. It held to 52 weeks in those who kept going. 829

The effect reverses. Patients who switched from tesamorelin to placebo at six months lost their visceral-fat improvement within the next six months. 24

Outside HIV, Makimura and colleagues randomized 60 adults with belly obesity and low GH secretion. They got tesamorelin or placebo for 12 months. Visceral fat fell (treatment effect -35 cm2 on CT). Carotid artery wall thickness, C-reactive protein and triglycerides improved. Subcutaneous fat and glucose measures did not change. This is the only controlled trial in people without HIV. 6

A trial in people with HIV and non-alcoholic fatty liver disease (61 patients) ran 12 months. Tesamorelin cut liver fat by a relative 37%. A normal liver-fat fraction was reached by 35% of patients, versus 4% on placebo. 7

In 53 patients with type 2 diabetes, 12 weeks of tesamorelin did not worsen insulin response, fasting glucose or HbA1c. 10

StudyModelFinding
Falutz 2007, NEJMHumans, n=412 with HIV and abdominal fat accumulation, randomized placebo-controlled, 26 weeksVisceral fat fell 15.2% versus a 5.0% increase on placebo; lipids improved. 8
Pooled phase 3 analysisHumans, n=806 pooled from two trials, with 26-week safety extensionTreatment effect on visceral fat about -15.4% at 26 weeks, maintained at 52 weeks on continued treatment. 9
Makimura 2012, obese adults without HIVHumans, n=60 abdominally obese adults with reduced GH secretion, randomized placebo-controlled, 12 monthsVisceral fat, carotid wall thickness, CRP and triglycerides improved; subcutaneous fat and glucose unchanged. 6
Stanley 2019, Lancet HIVHumans, n=61 with HIV and NAFLD, randomized placebo-controlled, 12 monthsLiver fat fell by a relative 37%; 35% versus 4% reached a normal liver-fat fraction. 7
Clemmons 2017, type 2 diabetesHumans, n=53 with type 2 diabetes, randomized placebo-controlled, 12 weeksNo change in insulin response or glycemic control at the trial doses. 10

Safety

In the HIV trials, the common effects were injection-site reactions, joint pain, swollen limbs, muscle aches and tingling. These fit with raised growth hormone. In the NEJM trial, more patients on tesamorelin than placebo quit because of adverse events. Overall event rates did not differ. The label warns about fluid retention, glucose intolerance and raised IGF-1. It advises considering stopping the drug if IGF-1 stays well above the normal range. It is contraindicated with active malignancy and in pregnancy. 81

The label says long-term heart safety has not been established. For off-label use the gap is wider. The whole controlled record is 60 people studied for one year. Compounded product adds doubt about potency and sterility, which the trials did not test. 56

Questions for your clinician

  • Is there controlled evidence for my situation, given the approved use is HIV lipodystrophy?
  • What happens to the fat after I stop the drug?
  • Is a compounded version equivalent to the approved product?

Questions people ask

Is compounded tesamorelin FDA-approved?

The molecule is approved as Egrifta, but only for HIV-associated lipodystrophy. A compounded preparation is not an FDA-approved product. Prescribing it for belly fat in someone without HIV is off-label use of an unreviewed preparation. 51

Does tesamorelin work for visceral fat in people without HIV?

One randomized trial of 60 obese adults with low GH secretion found that visceral fat and several heart markers improved over 12 months. Subcutaneous fat and blood sugar did not change. That is all the controlled evidence in this group. 6

What happens when you stop?

In the HIV trials, people who switched from tesamorelin to placebo after six months lost the visceral-fat reduction within the next six months. The benefit needs continued injections. 24

Does it raise blood sugar?

Growth hormone can oppose insulin, so researchers tracked this closely. The HIV trials and a 12-week trial in type 2 diabetes found no meaningful change in glucose or HbA1c. Still, the label lists glucose intolerance as a risk to monitor. 1091

Citations

  1. DailyMed: Egrifta SV (tesamorelin) prescribing information dailymed.nlm.nih.gov
  2. Falutz 2010, J Acquir Immune Defic Syndr: tesamorelin in HIV abdominal fat accumulation, RCT with extension pubmed.ncbi.nlm.nih.gov
  3. DailyMed: Egrifta WR (tesamorelin) prescribing information dailymed.nlm.nih.gov
  4. Falutz 2008, AIDS: long-term safety and effects of tesamorelin, extension study doi.org
  5. FDA label, 2025: Egrifta WR accessdata.fda.gov
  6. Makimura 2012, J Clin Endocrinol Metab: tesamorelin in obese subjects with reduced GH secretion, RCT pubmed.ncbi.nlm.nih.gov
  7. Stanley 2019, Lancet HIV: tesamorelin for NAFLD in HIV, RCT pubmed.ncbi.nlm.nih.gov
  8. Falutz 2007, NEJM: metabolic effects of a GHRH analog in patients with HIV pubmed.ncbi.nlm.nih.gov
  9. Falutz 2010, J Clin Endocrinol Metab: pooled analysis of two phase 3 tesamorelin trials pubmed.ncbi.nlm.nih.gov
  10. Clemmons 2017, PLoS One: tesamorelin in type 2 diabetes, RCT pubmed.ncbi.nlm.nih.gov
  11. 2007, Basic Clin Pharmacol Toxicol: non-clinical pharmacology of TH9507 pubmed.ncbi.nlm.nih.gov

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