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Evidence review

Tesamorelin Before and After: What the Trials Measured (Belly Fat, Not Muscle)

In its FDA trials, tesamorelin cut deep belly fat 14–18% in 26 weeks with no weight change — and the fat came back when people stopped. What that means for you.

Written by David ChenClinical Evidence & Regulatory Editor

In the two trials behind its FDA approval, tesamorelin reduced visceral (deep abdominal) fat by 18% and 14% over 26 weeks, against roughly no change on placebo. Body weight did not change, and when people stopped, the fat came back within six months. That is the honest before-and-after: a measurable change in belly fat on a CT scan, in adults with HIV-associated lipodystrophy — not a leaner, more muscular body in anyone who injects it.

Before and after, from the FDA label

MeasureTesamorelinPlacebo
Visceral fat, 26 weeks−14% to −18%−2% to +2%
Waist, 26 weeks−2 to −3 cm−1 cm
Trunk fat, 26 weeks−0.8 to −1.0 kg+0.2 to +0.4 kg
Body weight, 26 weeks−0.4 to +0.5 kg0 to +0.3 kg
Visceral fat, next 26 weeksKept taking it: −5% to 0%Switched to placebo: +16% to +22%
Egrifta prescribing information, section 14. Ranges span its two phase 3 studies in HIV-associated lipodystrophy. Visceral fat measured by CT scan.

What changes did tesamorelin produce in its trials?

Tesamorelin (brand name Egrifta) is FDA-approved for one use: "the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy"1. Two randomized, placebo-controlled trials of about 400 people each measured visceral fat by CT scan at 26 weeks123:

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  • Visceral fat: down 27 cm² (18%) in Study 1 and 21 cm² (14%) in Study 2. Placebo: up 4 cm² and flat1.
  • Waist: down about 2 to 3 cm, against 1 cm on placebo1.
  • Trunk fat: down 0.8 to 1.0 kg1.
  • Body weight: essentially unchanged — minus 0.4 kg in one trial, plus 0.5 kg in the other1.

So in a photo, the change is a smaller waist, not a lower number on the scale.

How long until visceral fat drops, and does it come back?

The trials measured at 26 weeks, so six months is the timeline the evidence supports. After that, people who finished the first phase on tesamorelin were re-randomized to keep taking it or switch to placebo for another 26 weeks1. People switched to placebo regained visceral fat — up 22% in Study 1 and 16% in Study 2 — while people who stayed on tesamorelin held their result1. The label tells prescribers to weigh continuing treatment in patients who have not had a reduction in visceral fat1. In short: the effect lasts only as long as the injections do.

Does tesamorelin build muscle or help non-HIV weight loss?

Weight loss: no. The label says it "is not indicated for weight loss management as it has a weight neutral effect"1.

Muscle: not shown. Lean body mass rose about 1.2 to 1.3 kg on scans in the trials1, but lean mass includes water and organs, and the trials did not measure strength or performance. Tesamorelin raises IGF-1, and the label lists fluid retention among its warnings1.

People without HIV: the approval rests on HIV lipodystrophy trials only. Any other use — including compounded tesamorelin sold for body composition — is off-label, without the same evidence behind it.

What side effects did the label report?

Over the first 26 weeks, more people on tesamorelin than on placebo reported1:

  • Injection site reactions (17% vs 6%)
  • Joint pain (13% vs 11%)
  • Muscle pain (6% vs 2%) and swelling in the legs or arms (6% vs 2%)
  • Tingling or numbness (5% vs 2%)

It also raised the risk of developing diabetes: 5% vs 1%1. Our tesamorelin side effects article covers the full list.

How does it compare with sermorelin?

Both stimulate the body's own growth hormone release, and both are banned in sport. The difference is evidence: tesamorelin has a current FDA label and two phase 3 trials with a measured outcome. Sermorelin's FDA-approved product, Geref, was discontinued, so no current label exists, and it has no trial measuring visceral fat. Our sermorelin vs. tesamorelin comparison goes through both. For sermorelin's own before-and-after evidence, see what the sermorelin studies show.

What do sellers charge?

Few telehealth sellers publish a tesamorelin price. Of the seven reviewed sellers whose sites list it, only one shows a figure, and that figure is a six-month rate:

Listed alphabetically. The prices we could read on sellers' own tesamorelin pages, including Nuform Health's $220 a month on a two-month plan, are side by side in our tesamorelin provider comparison.

The approved dose is 1.4 mg once daily for Egrifta SV, or 1.28 mg once daily for Egrifta WR — the two are not interchangeable1. Our tesamorelin dosing article covers the label, and the tesamorelin calculator does the vial math. The sermorelin sellers we track are the closest priced comparison.

Frequently asked questions

What are tesamorelin's before and after results?

In its two FDA trials, tesamorelin reduced visceral abdominal fat by 18% and 14% over 26 weeks, versus about no change on placebo, with a 2 to 3 cm smaller waist and no meaningful change in body weight. The trials enrolled adults with HIV-associated lipodystrophy.

How long does tesamorelin take to work?

The trials measured the result at 26 weeks, so six months is the timeline the evidence supports.

Does belly fat come back after stopping tesamorelin?

Yes. People switched to placebo after 26 weeks regained visceral fat over the next six months — up 22% and 16% in the two trials — while people who stayed on tesamorelin kept their result.

Does tesamorelin cause weight loss?

No. Its FDA label says it is not indicated for weight loss because it has a weight-neutral effect. It reduces deep abdominal fat without changing body weight.

Is tesamorelin FDA-approved?

Yes, as Egrifta, for reducing excess abdominal fat in adults with HIV-associated lipodystrophy. Any other use, including compounded tesamorelin sold for body composition, is off-label.

References

  1. Theratechnologies Inc. (2026). EGRIFTA SV (tesamorelin for injection) full prescribing information — sections 1 Indications and Usage, 2 Dosage and Administration, 6.1 Clinical Trials Experience and 14 Clinical Studies. DailyMed, National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224
  2. Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S (2007). Metabolic effects of a growth hormone-releasing factor in patients with HIV. New England Journal of Medicine. https://pubmed.ncbi.nlm.nih.gov/18057338/
  3. Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, Marsolais C, Turner R, Grinspoon S (2010). Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. Journal of Clinical Endocrinology and Metabolism. https://pubmed.ncbi.nlm.nih.gov/20554713/

Medical disclaimer: This content is for general educational purposes only and is not medical advice, diagnosis, or treatment. Always consult a licensed healthcare professional before starting, stopping, or changing any treatment.