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Evidence: HighPeptideFDA ApprovedEgrifta SV · Egrifta WRGHRH analogueHIV abdominal fat

Tesamorelin

The one drug approved for excess belly fat in HIV: it trims visceral fat by about 15% over placebo, but the fat returns when it stops and IGF-1 rises

Tesamorelin is a 44-amino-acid copy of the hormone GHRH with a small chemical cap that stabilises it. It makes the pituitary release more of its own growth hormone. Approved in the US since 2010 to reduce excess abdominal fat in adults with HIV-associated lipodystrophy, it cut visceral fat by about 15% more than placebo in two phase 3 trials of 806 patients, with no change in fat under the skin. The loss lasts only while it is taken, IGF-1 rose more than 2 standard deviations above normal in nearly half of patients, and HbA1c reached the diabetes range in 5% on the drug against 1% on placebo.

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Overview

What is it?

Tesamorelin is a synthetic version of growth hormone-releasing hormone: all 44 amino acids of the human hormone, with a trans-3-hexenoyl group added at the start of the chain, which stabilises it. It does not supply growth hormone. It signals the pituitary to release more of its own, so growth hormone rises in pulses and IGF-1 follows. In the US it is approved, as EGRIFTA SV and EGRIFTA WR, for one narrow purpose: reducing excess abdominal fat in adults with HIV who have lipodystrophy.

The approval rests on two phase 3 trials that together randomised 806 people with HIV and excess abdominal fat. After 26 weeks, visceral fat measured by CT scan fell by 24 cm² on tesamorelin while rising by 2 cm² on placebo, a treatment effect of 15.4%, and triglycerides fell; fat under the skin did not change, and neither did glucose in any clinically meaningful way. People kept the loss while they stayed on the drug for a year, and regained visceral fat when they stopped.

Later trials looked at the liver. In 61 people with HIV and fatty liver disease, a year of tesamorelin cut the liver's fat fraction by 4.1 percentage points more than placebo, a 37% relative reduction, and 35% of treated people fell below the 5% threshold for fatty liver, against 4% on placebo. A 2026 meta-analysis of five trials found reductions in visceral fat, trunk fat and liver fat and a gain in lean mass, with no significant change in fat under the skin or in body mass index.

The trade-offs are the hormonal ones. On the label, IGF-1 rose above 2 standard deviation scores in 47% of people after 26 weeks and above 3 in 36%, diabetes (HbA1c of 6.5% or more) developed in 5% against 1% on placebo, and injection-site reactions, joint pain and swelling were more common. About half of patients made antibodies to the drug. Europe never approved it: its EU application was withdrawn in June 2012, after the company reported that regulators could not weigh its benefits against its risks without cardiovascular data, given the higher IGF-1 levels.

−15.4%
visceral fat vs placebo
26 weeks, 806 patients, CT scan
−37%
liver fat fraction, relative
12 months, 61 people with HIV and fatty liver
36%
IGF-1 above 3 SDS
after 26 weeks (label)
5% vs 1%
developed diabetes
HbA1c ≥6.5%, drug vs placebo (label)
Science

Mechanism of Action

Tesamorelin works one step upstream of growth hormone. Everything below it on this page, the fat loss, the IGF-1 rise and the glucose effects, runs through the growth hormone the pituitary releases in response. The pathways come from the trials and the label.

Tesamorelin: how it reduces visceral fat, and where each step was shownA vertical pathway from tesamorelin's growth hormone release to less visceral and liver fat in people with HIV, which returns when treatment stops. A dashed red arrow marks that no trial measured heart attacks or strokes.TesamorelinReviewA synthetic analogue of growth hormone-releasing hormone, injected daily underthe skin.Growth hormone releaseReviewIt stimulates the synthesis and release ofthe body's own growth hormone.Less visceral fatPeopleIn 806 people with HIV and excessabdominal fat, visceral fat fell 15.4%more than on placebo at 26 weeks; fatunder the skin barely changed.Less liver fatPeopleIn 50 people with HIV over six months,liver fat fell against placebo alongsidevisceral fat.Only while takenPeopleThe visceral fat reduction held at 18%over 52 weeks on treatment, and the fatreturned when it was stopped.never testedFewer heart attacksPeopleThe trials here measured fat and bloodlipids; none measured heart attacks orstrokes.

Every fat measurement was made in people with HIV. Whether less visceral fat means fewer heart attacks or strokes has never been tested.

Each step is tagged with where it was shown. A dashed red arrow marks a link the evidence does not establish.

The pathway in words
  1. Tesamorelin. A synthetic analogue of growth hormone-releasing hormone, injected daily under the skin. Shown in: review. Source: PubMed 21668043.
  2. Growth hormone release. It stimulates the synthesis and release of the body's own growth hormone. Shown in: review. Source: PubMed 21668043.
  3. Less visceral fat. In 806 people with HIV and excess abdominal fat, visceral fat fell 15.4% more than on placebo at 26 weeks; fat under the skin barely changed. Shown in: people. Source: PubMed 20554713.
  4. Less liver fat. In 50 people with HIV over six months, liver fat fell against placebo alongside visceral fat. Shown in: people. Source: PubMed 25038357.
  5. Only while taken. The visceral fat reduction held at 18% over 52 weeks on treatment, and the fat returned when it was stopped. Shown in: people. Source: PubMed 18690162.
  6. never tested. Fewer heart attacks. The trials here measured fat and blood lipids; none measured heart attacks or strokes. Shown in: people. Source: PubMed 20554713.
↑

GHRH receptor: the pituitary's own growth hormone

Tesamorelin binds the receptor that natural GHRH uses on pituitary cells, raising basal and pulsatile growth hormone and, downstream, IGF-1. A two-week study in healthy people and people with HIV modelled its effect as growth hormone released in episodes, which carried through to IGF-1. It cannot work without a functioning pituitary, which is why the label rules it out after pituitary surgery, irradiation or disease.

↓

Visceral fat, not subcutaneous fat

In the phase 3 trials visceral fat fell while abdominal fat under the skin did not change. The fat that remained also changed character: in responders, CT density of both visceral and subcutaneous fat rose, which the authors read as smaller, healthier fat cells, and trunk muscles became denser and slightly larger.

◐

The liver

In people with HIV and fatty liver disease, tesamorelin lowered liver fat, and liver biopsies from that trial showed more activity in energy-producing pathways and less in inflammation and repair pathways. In the phase 3 trials, people whose visceral fat fell by at least 8% saw their liver enzymes improve.

⚠

IGF-1 and glucose

Growth hormone raises IGF-1 and can impair glucose control. The label reports IGF-1 above 3 standard deviation scores in 36% of patients at 26 weeks and a higher risk of diabetes, and asks for IGF-1 and glucose monitoring. In trials, fasting glucose rose briefly at two weeks but was no different from placebo at six months, and a 12-week trial in type 2 diabetes found no change in glycaemic control.

Evidence

Published Research

Our evidence set returned 44 papers that name tesamorelin, 25 of them in their titles. The 15 cards below are 13 human studies and two reviews. Almost all of the human evidence comes from people with HIV and excess abdominal fat or fatty liver, which is the population the drug was developed and approved for; the one trial in type 2 diabetes was designed to test glucose safety. What the studies do not show is any effect on heart attacks, strokes or survival, which none of them measured.

Human2010

The two phase 3 trials, pooled

806 people with HIV on antiretroviral therapy and excess abdominal fat were randomised 2:1 to 2 mg tesamorelin or placebo daily. At 26 weeks visceral fat fell by 24 cm² on the drug and rose by 2 cm² on placebo (treatment effect −15.4%), with no significant change in fat under the skin; triglycerides and the cholesterol-to-HDL ratio fell, IGF-1 rose by 108 ng/mL, and body image scores improved. Those who stayed on the drug kept the loss to week 52, with no clinically meaningful change in glucose.

PMID: 20554713
Human2008

Stopping brings the fat back

In the 26-week extension of the first phase 3 trial, people who stayed on tesamorelin kept an 18% reduction in visceral fat and a 51 mg/dL fall in triglycerides over 52 weeks, with adverse events and glucose changes similar to the first phase. People switched to placebo at week 26 regained visceral fat; the effect lasted only as long as the treatment.

PMID: 18690162
Human2014

Visceral and liver fat, JAMA

In a six-month trial in 50 people with HIV and abdominal fat, tesamorelin reduced visceral fat by 34 cm² against an 8 cm² gain on placebo and lowered liver fat, a net effect of −2.9% in the lipid-to-water ratio. Fasting glucose rose by 7 mg/dL more than on placebo at two weeks, but fasting and two-hour glucose did not differ from placebo over six months.

PMID: 25038357
Human2019

Fatty liver disease in HIV

61 people with HIV and a liver fat fraction of 5% or more took tesamorelin or placebo daily for a year. Liver fat fell by 4.1 percentage points more on tesamorelin, a 37% relative reduction, and 35% of the treated group ended below 5% against 4% on placebo. Fasting glucose and HbA1c did not differ between groups; injection-site complaints were more common on the drug but none was serious.

PMID: 31611038
Human2020

What the liver biopsies showed

Using paired liver biopsies from the fatty liver trial, researchers found that tesamorelin raised the activity of gene sets for oxidative phosphorylation and lowered those for inflammation, tissue repair and cell division, compared with placebo. The authors report that the trial showed tesamorelin prevented fibrosis progression over a year, and that these gene changes tracked a better fibrosis-related gene score.

PMID: 32701508
Human2024

On today's HIV regimens

The phase 3 trials predated integrase inhibitors, now standard HIV treatment. Among 38 participants in the fatty liver trial who were on integrase-inhibitor regimens, tesamorelin lowered visceral fat (median −25 vs +14 cm²), liver fat (−4.2% vs −0.5%) and the trunk-to-limb fat ratio compared with placebo over 12 months, with adverse events, including high blood sugar, at similar rates in both groups.

PMID: 38905488
Human2025

No clear benefit for thinking

In a six-month, open-label phase 2 trial, 73 virally suppressed people with HIV, abdominal obesity and neurocognitive impairment received tesamorelin or standard care. Waist circumference fell more on tesamorelin (median difference −2.7 cm), but the change in neurocognitive performance did not differ between groups. The authors note the trial had no placebo arm and too little power.

PMID: 39813152
Human2017

Type 2 diabetes: glucose safety

53 people with type 2 diabetes received placebo or 1 or 2 mg tesamorelin for 12 weeks. Insulin response, fasting glucose, HbA1c and overall diabetes control did not differ between groups, no one withdrew for loss of diabetes control, and total and non-HDL cholesterol fell on the 2 mg dose.

PMID: 28617838
Human2019

Denser, slightly larger muscles

An exploratory analysis of CT scans from the phase 3 trials compared 193 tesamorelin responders, whose visceral fat fell by at least 8%, with 148 people on placebo. Over 26 weeks responders gained density in four trunk muscle groups (1.56 to 4.86 Hounsfield units) and small gains in lean muscle area (0.64 to 1.08 cm²).

PMID: 31237318
Human2021

Better fat, not just less

In the same 193 responders and 148 placebo patients, CT density of visceral fat rose by 6.2 Hounsfield units on tesamorelin against 0.3 on placebo, and subcutaneous fat density by 4.0 against 0.3. The increases held after adjusting for changes in fat area, which the authors interpret as an improvement in fat quality independent of quantity.

PMID: 33756511
Human2017

Liver enzymes followed the fat

Among phase 3 participants on tesamorelin who started with ALT or AST above 30 U/L, those whose visceral fat fell by at least 8% saw larger drops in ALT (−8.9 vs +1.4 U/L) and AST (−3.8 vs +0.4 U/L) over 26 weeks than non-responders. The improvement persisted to week 52, even in those switched to placebo.

PMID: 28832410
Human2011

Inflammation and clotting markers

In 410 phase 3 participants, tesamorelin lowered tissue plasminogen activator antigen slightly more than placebo over 26 weeks; PAI-1 did not change significantly. Among treated patients, changes in PAI-1, tPA and adiponectin tracked the fall in visceral fat, which the authors describe as a modest effect whose clinical meaning is unknown.

PMID: 21516030
Human2015

How the body handles it

Pooling 38 healthy people and people with HIV given 1 or 2 mg under the skin daily for 14 days, a population model estimated clearance at 1,060 L/h and volume of distribution at 200 L. Age, body size, race and HIV status did not change its pharmacokinetics.

PMID: 25358450
Review2026

Meta-analysis of five trials

Pooling five randomised trials in people with HIV, tesamorelin reduced visceral fat (mean difference −27.7 cm²), trunk fat (−1.18 kg), limb fat (−0.22 kg), liver fat (−4.28 percentage points) and waist size (−1.61 cm), and increased lean mass by 1.42 kg. Fat under the skin, BMI and CD4 counts did not change. Adverse events included joint and muscle pain, tingling and injection-site redness.

PMID: 41545261
Review2011

Review at approval

A review written soon after approval describes tesamorelin as the first and only treatment indicated for excess abdominal fat in HIV-associated lipodystrophy. Visceral fat fell and stayed down through week 52 with continued use but came back after stopping; serious treatment-emergent adverse events occurred in under 4% over 26 weeks, mostly injection-site reactions or effects known from growth hormone, such as joint pain, headache and swelling.

PMID: 21668043
Dosing

Dosing Data

Tesamorelin's dose depends on the formulation. The phase 3 trials used 2 mg once daily of the original EGRIFTA; the current labels give 1.4 mg daily for EGRIFTA SV and 1.28 mg daily for EGRIFTA WR, which is mixed once a week, and the WR label cites comparable exposure to the 2 mg trial dose. All are injected under the skin of the abdomen.

Prescription only, for one approved use. The label asks for IGF-1 and glucose checks during treatment, says to consider stopping if visceral fat has not fallen, and rules it out in pregnancy, active cancer and pituitary disorders. Tesamorelin sold online as a 'research' powder is not the approved product.
ProtocolDoseFrequencyDurationRoute
EGRIFTA WR label Approved labelEGRIFTA WR (tesamorelin) for injection US prescribing information (DailyMed version 2, effective July 29, 2026)1.28 mgOnce daily; vial mixed weeklyOngoing; reassess if no responseSubcutaneous (abdomen)
EGRIFTA SV label Approved labelEGRIFTA SV (tesamorelin) for injection US prescribing information (DailyMed version 9, effective July 29, 2026)1.4 mgOnce dailyOngoing; reassess if no responseSubcutaneous (abdomen)
Phase 3 trials (original EGRIFTA) Human studyPMID 18690162; PMID 205547132 mgOnce daily26 weeks, then 26 moreSubcutaneous
Fatty liver trial (2019) Human studyPMID 316110382 mgOnce daily12 monthsSubcutaneous
Type 2 diabetes safety trial (2017) Human studyPMID 286178381 or 2 mgOnce daily12 weeksSubcutaneous

Educational information, not medical advice. Each dose above is tagged with its source: an approved label, a published human study, animal data, or amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.

→ Full Tesamorelin dosage guide — the doses on each label, what the trials used, and the monitoring the label asks for.

→ Blend & Stack Calculator — Tesamorelin is also sold in multi-peptide vials; the calculator shows what each draw delivers of every component; our blends and stacks hub sets out what each mix contains and what has been studied.

Label doses, not vial maths
Each EGRIFTA product comes with its own diluent and a fixed dose volume, 0.35 mL for SV and 0.16 mL for WR. The calculator handles general vial arithmetic; it cannot tell you what an unregulated 'research' vial of tesamorelin contains.
Open Calculator →
Safety

Side Effects & Contraindications

Reported Side Effects

From the EGRIFTA WR label's table of the 26-week phase 3 data (543 people on the drug, 263 on placebo) unless noted.

● Injection-site reactions (redness, itching, pain, swelling, rash): 17% vs 6% on placebo
● Joint pain 13% vs 11%, pain in a limb 6% vs 5%, muscle pain 6% vs 2%
● Swelling of the legs or feet 6% vs 2%; tingling 5% vs 2%; numbness 4% vs 2%
● Diabetes (HbA1c ≥6.5%): 5% vs 1%
● IGF-1 above 2 standard deviation scores in 47% and above 3 in 36% after 26 weeks
● Antibodies to tesamorelin in 50% at 26 weeks; they did not reduce its effect on visceral fat or IGF-1
● Visceral fat returns after stopping (phase 3 extension)

Contraindications & Cautions

From the EGRIFTA labels.

● Disrupted hypothalamic-pituitary axis: after hypophysectomy, pituitary tumour or surgery, head irradiation or head trauma, or with hypopituitarism (contraindicated)
● Active cancer (contraindicated); any earlier cancer must be inactive and its treatment complete
● Pregnancy (contraindicated): reducing visceral fat offers no benefit in pregnancy and could harm the fetus
● Known hypersensitivity to tesamorelin or the product's ingredients (contraindicated)
● Diabetes or impaired glucose tolerance: check glucose before and during treatment
● Persistently high IGF-1 (for example above 3 SDS): consider stopping, especially if the fat response is weak
● Acute critical illness: consider stopping, because growth hormone has increased mortality in critically ill patients
● Glucocorticoid replacement for adrenal insufficiency: doses may need to go up
Questions

Frequently Asked Questions

?Does tesamorelin cause weight loss?

Not much, and the label says it is not for weight loss because its effect on weight is neutral. It targets visceral fat, the fat around the organs: in the phase 3 trials visceral fat fell 15.4% more than on placebo over 26 weeks, while fat under the skin and body mass index did not change significantly.

?What happens when you stop tesamorelin?

The visceral fat comes back. In the phase 3 extensions, people switched to placebo after 26 weeks regained visceral fat, while those who stayed on the drug kept the loss to week 52. An analysis of liver enzymes found that improvements in people who had responded persisted to week 52 even after switching to placebo.

?Is tesamorelin the same as growth hormone?

No. It is a synthetic version of GHRH, the hypothalamic hormone that tells the pituitary to release growth hormone, so the growth hormone comes from the body's own pituitary, in pulses. That is also why it does not work, and is contraindicated, when the pituitary has been damaged or removed.

?Does tesamorelin raise blood sugar?

It can. On the label, diabetes (HbA1c of 6.5% or more) developed in 5% of people on the drug against 1% on placebo, and the label asks for glucose checks before and during treatment. In trials fasting glucose rose at two weeks but was no different from placebo at six months, and a 12-week trial in people with type 2 diabetes found no change in glucose control.

?Does tesamorelin help fatty liver?

In people with HIV, trials suggest it does. A year of treatment cut liver fat by 37% relative to placebo in 61 people with HIV and fatty liver disease, and 35% of treated people fell below the 5% threshold, against 4% on placebo. It is not approved for fatty liver, and it has not been tested for that in large trials or in people without HIV.

?Why was tesamorelin not approved in Europe?

The application was withdrawn before a decision. Ferrer Internacional withdrew it in June 2012, and Theratechnologies reported that the European committee could not conclude that benefits outweighed risks without data on cardiovascular risk markers, because higher IGF-1 levels were a potential concern for long-term use.

Bibliography

References

  1. [fda-pi] EGRIFTA WR (tesamorelin) for injection, Prescribing Information. Theratechnologies Inc. Revised March 2025; DailyMed, published August 3, 2026.
  2. [fda-pi] EGRIFTA SV (tesamorelin) for injection, Prescribing Information. Theratechnologies Inc. DailyMed, published July 31, 2026.
  3. [clinical-trial] Falutz J, et al. "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." J Clin Endocrinol Metab, 2010;95(9):4291-304. PMID: 20554713.
  4. [pubmed] Falutz J, et al. "Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation." AIDS, 2008;22(14):1719-28. PMID: 18690162.
  5. [clinical-trial] Stanley TL, et al. "Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial." JAMA, 2014;312(4):380-9. PMID: 25038357.
  6. [clinical-trial] Stanley TL, et al. "Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial." Lancet HIV, 2019;6(12):e821-e830. PMID: 31611038.
  7. [pubmed] Fourman LT, et al. "Effects of tesamorelin on hepatic transcriptomic signatures in HIV-associated NAFLD." JCI Insight, 2020;5(16). PMID: 32701508.
  8. [pubmed] Russo SC, et al. "Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors." AIDS, 2024;38(12):1758-1764. PMID: 38905488.
  9. [pubmed] Ellis RJ, et al. "Effects of Tesamorelin on Neurocognitive Impairment in Persons With HIV and Abdominal Obesity." J Infect Dis, 2025;231(5):1230-1238. PMID: 39813152.
  10. [pubmed] Clemmons DR, et al. "Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: A randomized, placebo-controlled trial." PLoS One, 2017;12(6):e0179538. PMID: 28617838.
  11. [pubmed] Adrian S, et al. "The Growth Hormone Releasing Hormone Analogue, Tesamorelin, Decreases Muscle Fat and Increases Muscle Area in Adults with HIV." J Frailty Aging, 2019;8(3):154-159. PMID: 31237318.
  12. [pubmed] Lake JE, et al. "Tesamorelin improves fat quality independent of changes in fat quantity." AIDS, 2021;35(9):1395-1402. PMID: 33756511.
  13. [pubmed] Fourman LT, et al. "Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV." AIDS, 2017;31(16):2253-2259. PMID: 28832410.
  14. [pubmed] Stanley TL, et al. "Effects of tesamorelin on inflammatory markers in HIV patients with excess abdominal fat: relationship with visceral adipose reduction." AIDS, 2011;25(10):1281-8. PMID: 21516030.
  15. [pubmed] González-Sales M, et al. "Population pharmacokinetic analysis of tesamorelin in HIV-infected patients and healthy subjects." Clin Pharmacokinet, 2015;54(3):285-94. PMID: 25358450.
  16. [review] Badran AS, et al. "Body composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: A meta-analysis of randomized controlled trials." Obes Res Clin Pract, 2026;20(1):2-12. PMID: 41545261.
  17. [review] Dhillon S. "Tesamorelin: a review of its use in the management of HIV-associated lipodystrophy." Drugs, 2011;71(8):1071-91. PMID: 21668043.
  18. [other] European Medicines Agency. Egrifta (tesamorelin): withdrawal of the marketing authorisation application, EMEA/H/C/002427, June 21, 2012.
  19. [other] Theratechnologies Inc. Material change report: Ferrer Internacional withdraws the EU marketing authorisation application for tesamorelin, June 22, 2012.
  20. [other] Health Canada Drug Product Database: EGRIFTA, drug codes 90838 and 92311 (Theratechnologies). Read September 26, 2026.

Sources & Citations

Every citation on this page is PubMed-indexed and has been checked against its record, except the EGRIFTA SV and EGRIFTA WR prescribing information, the EMA's record of the withdrawn EU application, Theratechnologies' report of it and Health Canada's Drug Product Database, which are cited as published. Grey Peptides sells nothing and links to no vendor.

Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Talk to a licensed clinician about your own situation.

Last reviewed: 2026-10-04