Tesamorelin
FDA ApprovedAn FDA-approved GHRH analog for reducing visceral fat in HIV-associated lipodystrophy. One of few GH-releasing peptides with regulatory approval and Phase 3 data.
Egrifta · Egrifta SV · Egrifta WR · TH9507
35 human studies
- Preclinical
- 8%
- Clinical
- 67%
Based on 52 cited sources
clinically demonstrated · high confidence
Demonstrated effect magnitude — not a recommendation or safety claim.
Research Depth 86: systematic review of 10 RCTs incl. tesamorelin (Sivakumar 21265979, n=1511, all low RoB) sits at the SR-of-RCTs tier (1A 33); pivotal low-RoB Phase 3 RCTs (Falutz NEJM 18057338 n=412; pooled 20554713 n=806) plus that SR give 1B 22, total human N >1,000 (1C 13) with direct population/route/outcome match (1D 14); preclinical program is modest (only ~4 preclinical sources) so 1E 4. Mechanism 85: GHRH-R is a named, functionally-validated class target (2A 35) with the full Gas->cAMP/PKA->GH ->hepatic IGF-1 / adipocyte-lipolysis chain mapped (2B 26), human 1mg-vs-2mg in-vivo dose-response (2C 14, 2D 10). Plausibility 89: full mechanism->IGF-1 surrogate->CT-measured VAT clinical outcome each supported (3A 36), coherent with GH/adipose physiology (3B 24), multiple same-class GHRH agents replicate GH release (3C 18), claim mostly scoped but several downstream effects asserted (3D 11). Global Coverage 57: replication concentrated in the Grinspoon/MGH + Theratechnologies (Canada) cluster (4A 16), 2-3 core countries (4B 13), ~52 studies across lipodystrophy/NAFLD/cognition angles (4C 18), FDA + Health Canada approval (4D 10). Community Experience 70: broad-but-niche anti-aging/clinic use (5A 20), >7-yr track record since 2010 approval (5B 26), broadly consistent reports (5C 14), only minor injection-site/glucose-monitoring signals (5D 10). Effectiveness basis clinical (high): ~15-18% treatment-effect VAT reduction and liver-fat normalization (35% vs 4% to HFF<5%, 31611038) exceed MCID on a largely surrogate/imaging endpoint, superior to placebo with no head-to-head active comparator for the indication.
Tesamorelin is a modified version of GHRH (growth hormone-releasing hormone) with FDA approval for HIV-associated lipodystrophy. It works by stimulating your pituitary gland to release growth hormone in natural pulses, targeting visceral fat specifically.
How It Works (Simplified)
Tesamorelin works by mimicking the body’s natural GHRH signal to release growth hormone:
Binds to GHRH receptors on pituitary somatotrophs, triggering natural GH release in physiologic pulses rather than continuous elevation.
GH preferentially mobilizes visceral fat due to higher receptor density and lipolytic sensitivity, sparing subcutaneous fat depots.
Hepatic GH signaling increases IGF-1 production by ~81%, normalizing levels and supporting anabolic and metabolic functions.
Reduces liver fat accumulation and improves hepatic oxidative phosphorylation, with evidence of fibrosis prevention in NAFLD.
Key Research: Falutz J et al. (2007) Phase 3 trial demonstrating 15.2% trunk fat reduction vs 5.0% increase with placebo. PMID:18057338
Important Limitations
- Effects do not persist after discontinuation - VAT returns within weeks
- Not approved for general weight loss, anti-aging, or athletic performance
- May impair glucose tolerance - monitor blood glucose
- Contraindicated with active malignancy due to GH/IGF-1 effects
- Short half-life (26-38 min) requires daily administration
Reported positives
- Effective visceral fat reduction with clinical backing
- FDA-approved status provides confidence in safety
- Improved body composition without significant muscle loss
- Cognitive benefits reported in aging populations
Reported negatives
- Expensive even through anti-aging clinics
- Injection site reactions common
- Effects reverse after discontinuation
- Insurance coverage limited to HIV lipodystrophy indication
“Gaining popularity in anti-aging clinics. FDA approval (Egrifta) gives it more legitimacy than research peptides.”
Self-reported, unverified accounts — not clinical evidence and no substitute for the cited research. Anecdotes are prone to selection bias and placebo effects.
| NCT ID | Title | Peptide | Phase | Status | Completion |
|---|---|---|---|---|---|
| NCT07481734 | Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study) Metabolic Associated Steatotic Liver Disease, Nonalcoholic Steatohepatitis +1 more | Tesamorelin | Phase 2 | Recruiting | Feb 2027 |
| NCT06554717 | Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV HIV-1-infection, Frailty +3 more | Tesamorelin | Phase 2 | Recruiting | Jun 2028 |
| NCT03375788 | Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk Non-Alcoholic Fatty Liver Disease, Obesity +3 more | Tesamorelin | Phase 2 | Completed | Jul 2024 |
| NCT03150511 | Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury Peripheral Nerve Injuries | Tesamorelin | Phase 2 | Recruiting | Dec 2027 |
| NCT03226821 | Body Composition and Adipose Tissue in HIV HIV Lipodystrophy Syndrome, Growth Hormone Deficiency +1 more | Tesamorelin | Phase 4 | Terminated | Apr 2025 |
| NCT02553603 | The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment Mild Cognitive Impairment | Tesamorelin | Phase 1 | Completed | Jan 2019 |
| NCT02572323 | Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons Mild Cognitive Impairment | Tesamorelin | Phase 2 | Completed | Oct 2023 |
| NCT02931474 | Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia Sleep Disorder, Traumatic Brain Injury | Tesamorelin | Phase 2 | Withdrawn | Mar 2017 |
| NCT02196831 | Tesamorelin Effects on Liver Fat and Histology in HIV Human Immunodeficiency Virus (HIV), Nonalcoholic Fatty Liver Disease (NAFLD) +1 more | Tesamorelin | Phase N/A | Completed | Jan 2019 |
| NCT01632592 | Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue Abdominal Obesity | Tesamorelin | Phase N/A | Withdrawn | Jan 2014 |
| NCT01591902 | Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA® Diabetic Retinopathy, HIV | Tesamorelin | Phase 4 | Terminated | May 2018 |
| NCT01388920 | Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting Chronic Obstructive Pulmonary Disease (COPD) | Tesamorelin | Phase 2 | Terminated | Dec 2011 |
| NCT01263717 | Effects of Growth Hormone Releasing Hormone in HIV HIV, HIV Lipodystrophy | Tesamorelin | Phase N/A | Completed | Feb 2014 |
| NCT00795210 | Effects of Short-term Growth Hormone in HIV-infected Patients HIV Lipodystrophy | Tesamorelin | Phase N/A | Completed | Nov 2012 |
| NCT00850564 | Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men Healthy Volunteers | Tesamorelin | Phase N/A | Completed | Apr 2010 |
| NCT00675506 | Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese Abdominal Obesity, Growth Hormone Deficiency | Tesamorelin | Phase 2 | Completed | Jan 2012 |
| NCT02012556 | Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients HIV | Tesamorelin | Phase 1 | Completed | Jul 2008 |
| NCT00608023 | TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy Lipodystrophy, HIV Infections | Tesamorelin | Phase 3 | Completed | Oct 2008 |
| NCT00257712 | SMART: Somatotrophics, Memory, and Aging Research Trial Aging, Mild Cognitive Impairment | Tesamorelin | Phase 2 | Completed | Dec 2011 |
| NCT00123253 | TH9507 in Patients With HIV-Associated Lipodystrophy HIV Infections, Lipodystrophy | Tesamorelin | Phase 3 | Completed | Nov 2006 |
| NCT01264497 | Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes Type 2 Diabetes | Tesamorelin | Phase 2 | Completed | Nov 2002 |
Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons
Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia
Tesamorelin Effects on Liver Fat and Histology in HIV
Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue
Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®
Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
Effects of Growth Hormone Releasing Hormone in HIV
Effects of Short-term Growth Hormone in HIV-infected Patients
Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese
Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
SMART: Somatotrophics, Memory, and Aging Research Trial
TH9507 in Patients With HIV-Associated Lipodystrophy
Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes
Based on clinical trials: IGF-1 levels increase by ~81% from baseline. Visceral fat reduction begins. Initial lipolytic effects on trunk fat measurable by imaging.
PMID:18057338Continued VAT reduction - Phase 3 trials showed 15.2% trunk fat reduction by week 12. Lean mass may increase (~1.4 kg). Body composition improvements become clinically apparent.
PMID:20554713Sustained effects with continued treatment. Mean VAT reduction of 27.7 cm² vs placebo in pooled Phase 3 analysis. Hepatic fat reduction observed in NAFLD studies.
PMID:20554713Long-term extension data confirms durability with continued dosing. Effects reverse within weeks of discontinuation - chronic treatment required for maintained benefits.
PMID:25038357Research-based observations
This timeline reflects observations from published clinical and preclinical studies. Individual responses may vary significantly. This is not a guarantee of effects or a dosing schedule. Consult qualified healthcare providers for personalized guidance.
Good Signs (6 indicators)
Warning Signs (4 indicators)
Bad Signs (6 indicators)
For Research Evaluation Only
These quality indicators are general guidelines based on typical peptide characteristics. Professional laboratory testing (HPLC, mass spectrometry) provides definitive quality verification. This checklist is for initial visual evaluation only.
Ipamorelin
SynergisticGHRH+GHRP synergy is well-established. Tesamorelin (GHRH) and ipamorelin (GHRP) act through complementary pathways for enhanced GH release.
GHRP-6
SynergisticClassic GHRH+GHRP combination. Tesamorelin amplifies while GHRP-6 initiates GH pulse. Greater combined effect than either alone.
GHRP-2
SynergisticSynergistic GH release through complementary GHRH and GHRP pathways. No direct combination studies with tesamorelin specifically.
Semaglutide
CautionTesamorelin increases GH which can affect glucose homeostasis. Monitor blood glucose carefully in diabetic patients.
Tirzepatide
CautionGH elevation may impact glucose metabolism. Monitor carefully if combined with incretin-based therapies.
Sermorelin
AvoidBoth are GHRH analogs acting on the same receptor. No benefit to combining; may cause receptor desensitization.
CJC-1295
AvoidBoth are GHRH analogs with identical mechanism. Use one or the other, not both.
Research Note: Interaction data is based on published literature, mechanistic understanding, and theoretical considerations. Most peptide combinations lack direct clinical study. This information is for educational purposes only and does not constitute medical advice. Always consult qualified healthcare providers.
Key Studies Cited
Full reference list available on request. All citations link to PubMed for verification.
This dossier synthesizes available evidence from peer-reviewed literature, regulatory documents, and clinical trial registries. Evidence strength ratings follow a modified GRADE approach.
For complete methodology details, see our Methodology page.
Important Disclaimer
This dossier is for educational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider before making health decisions.
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