What does the research show about tesamorelin?

Tesamorelin

In two phase 3 trials of adults with HIV, daily tesamorelin cut visceral fat 15.4% more than placebo over 26 weeks, and two meta-analyses agree. The fat came back after stopping. Lean mass rose about 1.4 kg and liver fat fell. Diabetes-range HbA1c developed in 5% against 1% on placebo, and injection site reactions and joint pain rose.

Add to Bio HackChecked 2026-11-09

Status: Prescription drug in the US. FDA-approved as Egrifta SV and Egrifta WR to reduce excess abdominal fat in adults with HIV and lipodystrophy. The label states it is not indicated for weight loss.
Also called: Egrifta, Egrifta SV, Egrifta WR, TH9507, tesamorelin acetate, GHRH analog, growth hormone-releasing factor analog
Taken for: belly fat, visceral fat, fat loss, liver fat, growth hormone, body composition

Strong several reviews agree · Moderate one review or consistent trials · Limited one or a few small studies · Untested no study in people, listed with what it rests on

Shown to help4

StrongShown to cut deep abdominal fat about 15% more than placebo in adults with HIV on treatment. Fat under the skin did not change.
StrongShown to add about 1.4 kg of lean mass over placebo in people with HIV. Lean mass is a scan measure, not strength.
ModerateShown to lower triglycerides about 12% more than placebo in adults with HIV. These are lab changes, and long-term heart effects are not established.
ModerateShown to lower liver fat about 3 to 4 points more than placebo in adults with HIV. Liver scarring and outcomes were not measured.

Reported risks4

ModerateShown to raise injection site reactions, 25% against 14% on placebo, in adults with HIV. Allergic reactions such as rash and hives occurred in 4%.Very common
ModerateShown to raise HbA1c into the diabetes range in 5% against 1% on placebo by 26 weeks in adults with HIV. Later glucose measures did not differ.Common
ModerateShown to raise joint pain, muscle pain and leg swelling slightly in adults with HIV, such as muscle pain in 6% against 2% on placebo.How often is not known
LimitedThe label warns of an increased risk of neoplasms and lists active cancer as a contraindication. IGF-1 rose 81% in one trial.How often is not known

What people take it for, and what was found

Shown to help4

Strong

Visceral (deep abdominal) fat in people with HIV

Shown to cut deep abdominal fat about 15% more than placebo in adults with HIV on treatment. Fat under the skin did not change.

The numbers and sources

Effect: At 26 weeks, visceral fat on CT changed by -15.2% on tesamorelin and +5.0% on placebo [1]. In the second phase 3 trial it changed by -10.9% against -0.6% [2]. Pooled across both trials, visceral fat changed by -24 cm² against +2 cm², a treatment effect of -15.4%. Fat under the skin of the abdomen did not differ from placebo (treatment effect -0.6%) [3]. In people who stayed on treatment to 52 weeks, visceral fat was 17.5% below baseline [3]. Two meta-analyses found visceral fat fell against placebo by a mean difference of -21.47 (95% CI -34.73 to -8.22, I² 74%) [4] and -27.71 cm² (95% CI -38.37 to -17.06) [5]. Trunk fat fell by about 1.2 kg and waist circumference by 1.61 cm (95% CI -2.28 to -0.95) [4][5].
Population: 412 adults with HIV on antiretroviral therapy with abdominal fat accumulation, 86% men [1]; 404 adults in the second trial [2]; 806 in the pooled analysis [3]; 909 people with HIV-associated lipodystrophy in 4 RCTs [4]; 5 RCTs against placebo [5].
Sources: [1], [2], [3], [4], [5]
Caveats: Every trial enrolled people with HIV on antiretroviral therapy, so the results do not describe people without HIV. Visceral fat is a scan measure, and no trial measured heart attacks or deaths. The two meta-analyses draw on largely the same trials. One found no significant change in fat under the skin or in BMI [5].

Strong

Lean body mass

Shown to add about 1.4 kg of lean mass over placebo in people with HIV. Lean mass is a scan measure, not strength.

The numbers and sources

Effect: Two meta-analyses found lean body mass rose by 1.42 kg against placebo (95% CI 1.13 to 1.71) [4][5].
Population: 909 people with HIV-associated lipodystrophy in 4 RCTs [4]; 5 RCTs against placebo [5].
Sources: [4], [5]
Caveats: Both reviews pooled largely the same trials in people with HIV. Lean mass is a scan measure, not strength.

Moderate

Triglycerides and cholesterol

Shown to lower triglycerides about 12% more than placebo in adults with HIV. These are lab changes, and long-term heart effects are not established.

The numbers and sources

Effect: At 26 weeks, triglycerides changed by -50 mg/dL on tesamorelin and +9 mg/dL on placebo, and the total to HDL cholesterol ratio by -0.31 against +0.21 [1]. Pooled across both trials, triglycerides changed by -37 against +6 mg/dL, a treatment effect of -12.3% [3].
Population: As above [1][3].
Sources: [1], [3]
Caveats: Laboratory changes only. The label states that long-term cardiovascular safety has not been established [6].

Moderate

Liver fat

Shown to lower liver fat about 3 to 4 points more than placebo in adults with HIV. Liver scarring and outcomes were not measured.

The numbers and sources

Effect: Pooled across RCTs, liver fat percentage fell by 4.28 points against placebo (95% CI -6.31 to -2.24) [5]. Over 6 months, liver fat changed by a median -2.0% (lipid to water) on tesamorelin and +0.9% on placebo, a net effect of -2.9%. Visceral fat fell by 42 cm² more than placebo (95% CI -71 to -14) [7]. In people with HIV and fatty liver disease, liver fat fraction fell 4.1 points more than placebo at 12 months (95% CI -7.6 to -0.7), a 37% relative reduction. Liver fat under 5% was reached by 35% on tesamorelin and 4% on placebo [8].
Population: RCTs in adults with HIV [5]; 50 adults with HIV and abdominal fat accumulation [7]; 61 adults with HIV and a liver fat fraction of 5% or more [8].
Sources: [5], [7], [8]
Caveats: One meta-analysis built on small trials. They measured liver fat, not liver scarring or liver outcomes. The 2019 trial was funded by the NIH [8].

Doses studied

The phase 3 trials and both liver fat trials used 2 mg by subcutaneous injection once daily, for 26 to 52 weeks [1][2][3][7][8]. The current Egrifta SV label dose is 1.4 mg once daily, and the label states its adverse reactions are expected to be similar to those seen with the original 2 mg dose [6].

Risks

Reported risks4

ModerateVery common

Injection site reactions and allergic reactions

Shown to raise injection site reactions, 25% against 14% on placebo, in adults with HIV. Allergic reactions such as rash and hives occurred in 4%.

The numbers and sources

How common: Very common: more than 1 in 10 people.
Effect: Injection site reactions occurred in 25% on tesamorelin and 14% on placebo during the first 26 weeks. Hypersensitivity reactions, including itching, redness, flushing, hives and rash, occurred in 4% of tesamorelin-treated patients [6]. More people on tesamorelin than placebo withdrew because of an adverse event [1]. Pooled across 4 RCTs, discontinuation rates were higher on tesamorelin (RR 2.25, 95% CI 0.98 to 5.17, p = 0.06) [4].
Population: 543 adults on tesamorelin and 263 on placebo in the 26-week phase [6]; 412 adults [1]; 909 people in 4 RCTs [4].
Sources: [6], [1], [4]
Caveats: In the liver trial, local injection site complaints were more common on tesamorelin, and none were judged serious [8].

ModerateCommon

Raised blood sugar and diabetes

Shown to raise HbA1c into the diabetes range in 5% against 1% on placebo by 26 weeks in adults with HIV. Later glucose measures did not differ.

The numbers and sources

How common: Common: between 1 in 100 and 1 in 10 people.
Effect: In the phase 3 trials, HbA1c reached 6.5% or more by week 26 in 5% on tesamorelin and 1% on placebo, a hazard ratio of 3.3 (CI 1.4 to 9.6) [6]. Fasting glucose rose 7 mg/dL more than placebo at 2 weeks, with no difference at 6 months [7]. Fasting glucose and HbA1c did not differ from placebo at 12 months in the liver trial [8].
Population: 806 adults with HIV in the phase 3 program [3][6]; 50 adults [7]; 61 adults [8].
Sources: [6], [7], [8]
Caveats: Mean baseline HbA1c was 5.3% in the phase 3 trials [6]. The pooled trial report found no clinically meaningful glucose differences [3], and a 2026 meta-analysis of 5 RCTs reported no change in glucose [5].

ModerateHow often is not known

Joint pain, muscle pain and swelling

Shown to raise joint pain, muscle pain and leg swelling slightly in adults with HIV, such as muscle pain in 6% against 2% on placebo.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: Over 26 weeks, joint pain occurred in 13% on tesamorelin and 11% on placebo, pain in a limb in 6% against 5%, muscle pain in 6% against 2%, swelling of the legs in 6% against 2%, and carpal tunnel syndrome in 1% against 0% [6]. A meta-analysis of 5 RCTs also linked tesamorelin with joint pain, muscle pain and tingling (paresthesia) [5].
Population: 543 adults on tesamorelin and 263 on placebo [6]; 5 RCTs [5].
Sources: [6], [5]
Caveats: The label groups these as fluid retention effects [6].

LimitedHow often is not known

Raised IGF-1 and a cancer warning

The label warns of an increased risk of neoplasms and lists active cancer as a contraindication. IGF-1 rose 81% in one trial.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: IGF-1 rose 81.0% on tesamorelin and fell 5.0% on placebo [1]. The label states the effects of prolonged IGF-1 elevation are unknown, warns of an increased risk of neoplasms, and lists active malignancy as a contraindication [6].
Population: 412 adults with HIV [1]; label [6].
Sources: [1], [6]
Caveats: The cancer warning is a label precaution. The sourced trials did not report cancer rates.

Claims tested and not found

That the fat stays off after stopping. Visceral fat reaccumulated when tesamorelin was stopped [9]. People switched from tesamorelin to placebo lost the earlier visceral fat reduction quickly [2].
That tesamorelin causes weight loss. The label states it is not indicated for weight management and has a weight-neutral effect [6].

Sources

Falutz J, Allas S, Blot K, et al. Metabolic Effects of a Growth Hormone-Releasing Factor in Patients with HIV. New England Journal of Medicine. 2007. https://doi.org/10.1056/NEJMoa072375
Falutz J, Potvin D, Mamputu JC, et al. Effects of Tesamorelin, a Growth Hormone-Releasing Factor, in HIV-Infected Patients With Abdominal Fat Accumulation: A Randomized Placebo-Controlled Trial With a Safety Extension. Journal of Acquired Immune Deficiency Syndromes. 2010. https://doi.org/10.1097/QAI.0b013e3181cbdaff
Falutz J, Mamputu JC, Potvin D, 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. Journal of Clinical Endocrinology and Metabolism. 2010. https://doi.org/10.1210/jc.2010-0490
Ditta AM, Naeem RM, Sami MM, et al. Efficacy and Safety of Tesamorelin in People Living With HIV (PLWH) With Lipodystrophy: A Systematic Review and Meta-Analysis. Journal of the International Association of Providers of AIDS Care. 2026. https://doi.org/10.1177/23259582261475549
Badran AS, Helal A, Shata KS, 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. Obesity Research & Clinical Practice. 2026. https://doi.org/10.1016/j.orcp.2026.01.002
U.S. Food and Drug Administration. EGRIFTA SV (tesamorelin) for injection, prescribing information. Revised 2024. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224
Stanley TL, Feldpausch MN, Oh J, 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. https://doi.org/10.1001/jama.2014.8334
Stanley TL, Fourman LT, Feldpausch MN, et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. The Lancet HIV. 2019. https://doi.org/10.1016/S2352-3018(19)30338-8
Falutz J, Allas S, Mamputu JC, et al. Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. AIDS. 2008. https://doi.org/10.1097/QAD.0b013e32830a5058

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