Research information only, not medical advice. Tesamorelin is an FDA-approved drug. A growth-hormone-releasing hormone (GHRH) analog, it is approved (Egrifta, 2010; Egrifta SV, 2019; Egrifta WR, 2025) to reduce excess visceral abdominal fat in adults with HIV-associated lipodystrophy — the only US-approved medication for that indication. Uses outside that indication are off-label and not FDA-approved.
Tesamorelin at a glance
Tesamorelin is supported by randomized controlled trials in HIV-associated lipodystrophy that led to its FDA approval; evidence outside that indication is limited. See the indexed studies below, graded by evidence level.
See also Tesamorelin vs CJC-1295 .
Evidence profile
65 studies- Human RCT 12 · 18%
- Human trial 6 · 9%
- Review 32 · 49%
- Animal 6 · 9%
- In-vitro 4 · 6%
- Unknown 5 · 8%
The longer the green, the stronger the human evidence. For most research peptides the bar is dominated by animal and in-vitro work, which is a signal to read every claim carefully.
Regulatory status
- 2025-03-25 US-FDA
FDA approves EGRIFTA WR (tesamorelin F8 formulation) for excess visceral abdominal fat in adults with HIV and lipodystrophy. source
Clinical trials
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TH9507 in Patients With HIV-Associated Lipodystrophy
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SMART: Somatotrophics, Memory, and Aging Research Trial
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TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
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Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese
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Effects of Short-term Growth Hormone in HIV-infected Patients
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Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
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Effects of Growth Hormone Releasing Hormone in HIV
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Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes
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Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
- NCT01579695 TERMINATED
Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®
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Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®
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Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue
- NCT01788462 WITHDRAWN
Egrifta Replacement and Sleep Disordered Breathing
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Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients
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Tesamorelin Effects on Liver Fat and Histology in HIV
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The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
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Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons
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Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia
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Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
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Body Composition and Adipose Tissue in HIV
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Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
- NCT03826160 COMPLETED
Growth Hormone Dynamics and Cardiac Steatosis in HIV
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Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
Indexed research
Sorted by evidence level, strongest first.
- Human RCT 2025Effects of Tesamorelin on Neurocognitive Impairment in Persons With HIV and Abdominal Obesity
- Human RCT 2024Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors
- Human RCT 2023Effect of tesamorelin in people with HIV with and without dorsocervical fat: Post hoc analysis of phase III double-blind placebo-controlled trial
A post hoc analysis of a phase III double-blind placebo-controlled trial found that tesamorelin reduced visceral adipose tissue and waist circumference comparably in people with HIV regardless of whether they had dorsocervical fat.
- Human RCT 2021Growth Hormone Releasing Hormone Reduces Circulating Markers of Immune Activation in Parallel with Effects on Hepatic Immune Pathways in Individuals with HIV-infection and Nonalcoholic Fatty Liver Disease
- Human RCT 2021Tesamorelin improves fat quality independent of changes in fat quantity
A secondary analysis of two placebo-controlled randomized trials in people with HIV found that tesamorelin increased visceral and subcutaneous fat density (a marker of fat quality) over 26 weeks, independent of reductions in fat quantity.
- Human RCT 2021Clinical Predictors of Liver Fibrosis Presence and Progression in Human Immunodeficiency Virus-Associated Nonalcoholic Fatty Liver Disease
- Human RCT 2021Delineating tesamorelin response pathways in HIV-associated NAFLD using a targeted proteomic and transcriptomic approach
A secondary analysis of a randomized controlled trial found that tesamorelin significantly reduced plasma VEGFA, TGFB1, and CSF1, with these decreases correlating with improvements in NAFLD activity and fibrosis scores in people with HIV-associated NAFLD.
- Human RCT 2026P-1230. Tesamorelin (EGRIFTA WR and EGRIFTA®) Formulations: Bioequivalence in Healthy Participants
A phase I randomized, blinded, crossover trial in 36 healthy adults found that a more concentrated, smaller-volume tesamorelin formulation (EGRIFTA WR) was bioequivalent to the original EGRIFTA® formulation and was generally safe and well tolerated.
- Human RCT 20231499. Tesamorelin Reduces Visceral Adipose Tissue and Liver Fat in INSTI-Treated Persons with HIV
A post-hoc analysis of a placebo-controlled trial in 61 people with HIV-associated NAFLD found that tesamorelin significantly reduced visceral adipose tissue and liver fat among those on INSTI-containing regimens.
- Human RCT 2010Effects 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
A pooled analysis of two phase-3 multicenter, double-blind, placebo-controlled randomized trials found that tesamorelin 2 mg daily significantly reduced visceral adipose tissue and improved lipids and body image in ART-treated HIV patients with excess abdominal fat, with reductions maintained up to 52 weeks and good tolerability.
+ 55 more studies indexed for Tesamorelin.
Frequently asked questions
- Is Tesamorelin approved for human use?
- Tesamorelin is an FDA-approved drug. A growth-hormone-releasing hormone (GHRH) analog, it is approved (Egrifta, 2010; Egrifta SV, 2019; Egrifta WR, 2025) to reduce excess visceral abdominal fat in adults with HIV-associated lipodystrophy — the only US-approved medication for that indication. Uses outside that indication are off-label and not FDA-approved.
- What does the research on Tesamorelin show?
- Tesamorelin is supported by randomized controlled trials in HIV-associated lipodystrophy that led to its FDA approval; evidence outside that indication is limited. See the indexed studies below, graded by evidence level.