Clinical trial· 2007
Metabolic effects of a growth hormone-releasing factor in patients with HIV.
The New England journal of medicine
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Human outcomesFDA-approved product · narrow indication
Tesamorelin
GHRH analog
Also indexed as: Egrifta · TH9507
What this evidence does not tell us
The approved indication is reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. It is not a general weight-loss drug; long-term cardiovascular safety is not established.
Terms on this page
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10 glossary terms used in this profile
Terms on this page
Unfamiliar word? Open this panel for simple explanations, right here.
10 glossary terms used in this profile
Select a word to see its meaning. You can keep more than one definition open.
Definitions explain the words—not whether a molecule works or is safe. Research education only, not medical advice.
Overview
Tesamorelin is a synthetic growth hormone-releasing hormone analog. Egrifta products have an FDA-approved indication involving excess abdominal fat in adults with HIV-associated lipodystrophy.
Mechanism of action
GHRH / GH–IGF-1
Activates pituitary GHRH receptors, increasing endogenous GH and downstream IGF-1 signaling. The demonstrated visceral-fat outcome concerns the specifically studied HIV-lipodystrophy population.
A biological pathway describes a proposed or observed interaction—not necessarily a demonstrated health outcome.
Decode the terminology in our glossaryScientific evidence
How strong is the evidence?
Stronger human evidence · specific uses
- Limited evidence
- Early research
- Human research
- Human outcomesCurrent category
Controlled human trials support specific outcomes in the people studied. That does not prove every claimed use, remove risks or make a treatment right for everyone.
For this research: The approved indication is reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. It is not a general weight-loss drug; long-term cardiovascular safety is not established.
An editorial guide—not a validated score, a percentage, a safety rating or an approval badge. Regulatory status is separate. More research does not mean fewer risks.
Cell studies
Mechanistic laboratory evidence is not separately assessed in this selected-source summary; see references and their study types.
Animal experiments
Animal evidence is not separately assessed here. Findings in animals must not be interpreted as demonstrated human benefit.
Human observational studies
Associations, biomarker studies and anecdotes cannot establish treatment causality; no observational result is used here to infer clinical effectiveness.
Human clinical trials
Randomized trials studied visceral fat in adults with HIV-associated lipodystrophy, not general obesity.
Regulatory evidence
Egrifta products are approved to reduce excess abdominal fat in HIV-infected adults with lipodystrophy, not for general weight management.
Potential research applications
Visceral adipose tissue in adults with HIV-associated lipodystrophy.
These describe scientific questions, not prescribing recommendations. A research grouping does not establish combination safety or clinical effectiveness.
Explore research by health goalSafety considerations
Contraindicated in pregnancy, active malignancy, disruption of the hypothalamic-pituitary axis or hypersensitivity. Risks include elevated IGF-1, glucose intolerance and fluid retention.
This is not an exhaustive safety or contraindication list. An absence of reported harm is not proof of safety. Pregnancy, breastfeeding, cancer history, endocrine disease and concurrent medicines can materially change risk. Unregulated preparations add identity, contamination and sterility risks.
Regulatory status · United States
FDA-approved product · narrow indication
Egrifta products are approved to reduce excess abdominal fat in HIV-infected adults with lipodystrophy, not for general weight management.
Read the official regulatory sourceRegulatory status and evidence strength are different. A nomination for compounding, a clinical-trial registration or a “research use only” label is not approval. International rules vary; consult the current regulator and product label.
Selected literature & source transparency
Matched bibliographic records confirm a publication’s identity, not the validity of every claim. Selected sources are not a systematic literature review.
Continue your own source search
These open search results, not additional verified citations. Trial registration is not evidence that a treatment works.
Three questions worth bringing to your clinician
- Which human outcomes—not just biomarkers—support this claim?
- What established options address my actual health concern?
- What do my medical history and current medicines change about the risks?
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