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Tesamorelin research

What published studies found for Tesamorelin: 8 papers, 8 in humans, with sample sizes and key results, plus 20 registered clinical trials.

A
Strong human evidence
Why: Approved drug; two RCTs of about 400 people each and two meta-analyses show consistent visceral-fat reduction in HIV; other uses rest on single small RCTs.

Tesamorelin, an FDA-approved GHRH(1-44) analog, has multiple placebo-controlled RCTs and two meta-analyses showing it reduces visceral and liver fat in people with HIV-associated abdominal fat accumulation; effects fade after stopping. Evidence outside HIV (obesity, cognition) comes from single smaller RCTs, and there is no evidence for orthopaedic or performance uses.

✓ 7 positive✗ 1 negative

Trials up to 12 months generally found no worsening of glucose control, but long-term safety data are limited and benefits reverse after stopping.

US compounding: FDA-approved drug. FDA-approved (Egrifta) for HIV-associated abdominal fat. Status for every peptide.

Browse and filter these papersTesamorelin prices and vendors

Reported side effects

Registered clinical trials

20 trials of Tesamorelin on ClinicalTrials.gov: 3 active, 10 completed, 8 with posted results. Registered trials include ones that haven't published yet.

TrialStatusPhasePeopleSponsor
Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)NCT07481734 · started 2026-02-02RecruitingPhase 2120Hudson Biotech
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIVNCT06554717 · started 2025-07-10RecruitingPhase 2100Massachusetts General Hospital
Tesamorelin to Improve Functional Outcomes After Peripheral Nerve InjuryNCT03150511 · started 2018-06-01RecruitingPhase 236Johns Hopkins University
TH9507 Extension Study in Patients With HIV-Associated LipodystrophyNCT00608023 · started 2007-08 · results postedCompletedPhase 3263Theratechnologies
Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected PersonsNCT02572323 · started 2017-02-15 · results postedCompletedPhase 273University of California, San Diego
Tesamorelin Effects on Liver Fat and Histology in HIVNCT02196831 · started 2015-07-01 · results postedCompleted–61Massachusetts General Hospital
Effects of Growth Hormone Releasing Hormone in HIVNCT01263717 · started 2010-12 · results postedCompleted–54Massachusetts General Hospital
Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular RiskNCT03375788 · started 2019-01-17 · results postedCompletedPhase 251Massachusetts General Hospital
Effect of Short Term Growth Hormone Releasing Hormone in Healthy MenNCT00850564 · started 2009-02 · results postedCompleted–15Massachusetts General Hospital
Body Composition and Adipose Tissue in HIVNCT03226821 · started 2018-02-07 · results postedTerminatedPhase 46Columbia University
Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle WastingNCT01388920 · started 2011-09 · results postedTerminatedPhase 23Theratechnologies
TH9507 in Patients With HIV-Associated LipodystrophyNCT00123253 · started 2005-06CompletedPhase 3412Theratechnologies

All 20 Tesamorelin trials, with countries and recruiting status

Meta-analyses & systematic reviews

✓ Positivemeta-analysisJ Int Assoc Provid AIDS Care · 2026

Efficacy and Safety of Tesamorelin in People Living With HIV (PLWH) With Lipodystrophy: A Systematic Review and Meta-Analysis.

n = 909 humansSystematic review and meta-analysis of RCTs with GRADE assessment

Across 4 RCTs (909 patients), tesamorelin reduced visceral fat, waist and trunk fat and increased lean mass; GH-related adverse effects and a trend to more discontinuations (RR 2.25, p = 0.06) were noted, with limited long-term safety data.

Key resultTesamorelin 2mg reduced visceral adipose tissue (MD= -21.47, 95%CI -34.73 to -8.22; p=0.002) and increased lean body mass (MD 1.42kg, p<0.00001); discontinuation RR 2.25 (95%CI 0.98 to 5.17; p=0.06)
Studied
People living with HIV with lipodystrophy on combined antiretroviral therapy
Compared with
Placebo/control
Main outcome
Visceral adipose tissue, waist circumference, trunk fat, lean mass, lipids, safety
Sample
4 RCTs, 909 patients
Authors' conclusion
Tesamorelin reduces visceral adiposity in people with HIV lipodystrophy on CART, but limited long-term safety, dosing and durability data warrant caution.
Limitations
Limited data on long-term safety, optimal dosing and durability; higher discontinuation rates.
PubMed 42538058DOIFree full text
✓ Positivemeta-analysisObes Res Clin Pract · 2026

Body composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: A meta-analysis of randomized controlled trials.

5 randomized controlled trialsSystematic review and random-effects meta-analysis of RCTs

Across 5 RCTs in adults with HIV, tesamorelin reduced visceral fat (-27.7 cm²), trunk fat and liver fat (-4.3%) and increased lean mass (+1.4 kg) vs placebo, without changing glucose; arthralgia, myalgia, paresthesia and injection-site reactions were reported.

Key resultVisceral adipose tissue MD=-27.71 cm2 (95% CI -38.37 to -17.06; P < 0.001); hepatic fat MD=-4.28 % (95% CI -6.31 to -2.24; P < 0.001); lean body mass MD=1.42 kg (P < 0.001)
Studied
Adults with HIV-associated lipodystrophy
Compared with
Placebo
Main outcome
Visceral adipose tissue, trunk fat, hepatic fat, lean body mass, safety
Authors' conclusion
Tesamorelin improves body composition, hepatic fat, lean body mass and IGF-1 in HIV-associated lipodystrophy, without serious side effects or perturbation of glucose. Adverse events included arthralgia, myalgia and injection-site reactions.
Limitations
Only five RCTs; no significant reduction in subcutaneous fat or BMI.
PubMed 41545261DOI

Human studies

✓ Positivehuman RCTN Engl J Med · 2007

Metabolic effects of a growth hormone-releasing factor in patients with HIV.

n = 412 humansRandomized placebo-controlled trial26 weeks

In 412 patients with HIV and abdominal fat, 26 weeks of tesamorelin reduced visceral fat 15.2% (vs +5.0% placebo) and lowered triglycerides; overall adverse events were similar but more tesamorelin patients withdrew due to adverse events.

Key resultVisceral adipose tissue decreased 15.2% with tesamorelin vs increased 5.0% with placebo (P<0.001); triglycerides fell 50 mg/dL vs rose 9 mg/dL
Studied
Patients with HIV (86% men) with abdominal fat accumulation
Compared with
Placebo
Main outcome
Percent change in visceral adipose tissue on CT
Sample
412 patients with HIV randomized
Authors' conclusion
Daily tesamorelin for 26 weeks decreased visceral fat and improved lipid profiles in HIV-infected patients with treatment-associated central fat accumulation; more patients on tesamorelin withdrew due to adverse events.
Limitations
More withdrawals due to adverse events in the tesamorelin group.
PubMed 18057338DOI
✓ Positivehuman RCTJ Acquir Immune Defic Syndr · 2010

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.

n = 404 humansRandomized placebo-controlled trial (2:1) with a re-randomized safety extension, blinded12 months (6-month efficacy phase plus 6-month extension)

In 404 patients with HIV, tesamorelin cut visceral fat 10.9% vs 0.6% with placebo at 6 months (~18% at 12 months) and improved belly-appearance distress; gains were rapidly lost after switching to placebo.

Key resultVAT decreased -10.9% with tesamorelin vs -0.6% with placebo at 6 months (P < 0.0001); about 18% reduction at 12 months with continued tesamorelin (P < 0.001)
Studied
HIV-infected patients on antiretroviral therapy with excess abdominal fat
Compared with
Placebo
Main outcome
Visceral adipose tissue (VAT)
Sample
404 HIV-infected patients, 12-month study
Authors' conclusion
Tesamorelin reduces visceral fat by approximately 18% and improves body image distress without significant side effects or perturbation of glucose. Benefits were rapidly lost on switching to placebo.
Limitations
VAT improvements were lost after switching from tesamorelin to placebo.
PubMed 20101189DOI
✓ Positivehuman RCTArch Neurol · 2012

Effects of growth hormone–releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial.

n = 152 humansRandomized, double-blind, placebo-controlled trial20 weeks (plus 10-week washout)

In 152 older adults (66 with MCI), 20 weeks of tesamorelin improved a cognitive composite (p = 0.03), mainly executive function; mild adverse events occurred in 68% vs 36% on placebo, and fasting insulin rose 35% in the MCI group.

Key resultFavorable effect of GHRH on cognition in intent-to-treat analysis (P=.03); executive function (P=.005); IGF-1 increased 117%
Studied
Healthy older adults and adults with mild cognitive impairment, aged 55 to 87
Compared with
Placebo
Main outcome
Composite cognitive scores (executive function, verbal memory, visual memory)
Sample
152 adults (66 with MCI); 137 completed
Authors' conclusion
Twenty weeks of GHRH had favorable effects on cognition in both MCI and healthy older adults. Longer-duration trials are needed.
Limitations
Adverse events were mild but more frequent with GHRH (68% vs 36%); longer trials needed.
PubMed 22869065DOIFree full text
✓ Positivehuman RCTLancet HIV · 2019

Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial.

n = 61 humansRandomised, double-blind, multicentre placebo-controlled trial with 6-month open-label phase12 months

In 61 people with HIV and fatty liver, 12 months of tesamorelin reduced hepatic fat fraction by an absolute 4.1% (37% relative) vs placebo, with no difference in glucose or HbA1c; more injection-site complaints.

Key resultHFF absolute effect -4.1% (95% CI -7.6 to -0.7, p=0.018); 35% vs 4% had HFF below 5% (p=0.0069)
Studied
People with HIV and NAFLD (hepatic fat fraction of 5% or more)
Compared with
Placebo
Main outcome
Change in hepatic fat fraction (HFF)
Sample
61 patients enrolled (30 tesamorelin, 30 placebo)
Authors' conclusion
Tesamorelin might be beneficial in people with HIV and NAFLD. Further studies are needed on long-term effects on liver histology.
Limitations
Small trial; long-term histological effects not established.
PubMed 31611038DOIFree full text
✓ Positivehuman RCTJ Clin Endocrinol Metab · 2012

Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trial.

n = 60 humansRandomized, double-blind, placebo-controlled study12 months

In 60 abdominally obese adults without HIV but with low GH, 12 months of tesamorelin reduced visceral fat (-35 cm² vs placebo), triglycerides, CRP and carotid IMT without affecting glucose.

Key resultVAT treatment effect -35 cm2 (95% CI -58 to -12; P = 0.003); triglycerides -37 mg/dl (P = 0.02); no significant effect on subcutaneous fat; no glucose changes
Studied
Abdominally obese subjects with reduced GH secretion
Compared with
Placebo
Main outcome
Visceral adipose tissue and cardiovascular risk indices
Sample
60 abdominally obese subjects with reduced GH secretion
Authors' conclusion
In obese subjects with relative GH reduction, tesamorelin selectively reduces VAT and improves triglycerides, C-reactive protein and carotid intima-media thickness, without aggravating glucose.
PubMed 23015655DOIFree full text
✗ Negativehuman RCTJ Infect Dis · 2025

Effects of Tesamorelin on Neurocognitive Impairment in Persons With HIV and Abdominal Obesity.

Seventy-three participants randomized 3:2Phase 2 randomized open-label trial6 months

In 73 people with HIV and abdominal obesity, 6 months of open-label tesamorelin reduced waist circumference (-2.7 cm vs standard care) but did not significantly improve neurocognitive performance vs standard care.

Key resultBetween-group difference in neurocognitive change not significant (P = .673); waist circumference median difference -2.7 cm (P = .015)
Studied
Virally suppressed people with HIV, abdominal obesity and neurocognitive impairment
Compared with
Standard of care
Main outcome
Change in neurocognitive performance at 6 months
Authors' conclusion
Tesamorelin reduced waist circumference but cognitive benefits did not significantly differ between groups; no clear benefit of short-term abdominal obesity reduction on neurocognitive impairment.
Limitations
Insufficient power and no placebo arm.
PubMed 39813152DOI

Verdicts are judged on each paper's own main outcome; grades run from A (strong human evidence) to D (little or none). Details are read from the abstracts, and figures are reproduced only from openly licensed full texts. Not medical advice.