# Tesamorelin: The GHRH(1-44) Analogue Trial Record > Tesamorelin is a synthetic GHRH(1-44) analogue FDA-approved only for HIV-associated lipodystrophy. The visceral-fat, liver-fat, and IGF-1 figures read straight off the published trials, every claim cited. The full trial record, read straight off the page: what the studies measured, the one indication it is approved for, and the hard line where every other use becomes off-label. ## The short version Tesamorelin is a lab-made copy of GHRH (the brain's own "make growth hormone" signal), built to last longer in the blood than the natural version. It nudges the pituitary gland to release the body's own growth hormone, which then raises IGF-1 (a growth signal the liver makes when growth hormone rises). The practical effect studied in trials: it shrinks visceral fat (the deep belly fat packed around the organs). It is FDA-approved for exactly one thing — reducing that deep belly fat in adults with HIV-associated fat redistribution. Every other use is off-label and not approved. ## What the tesamorelin record actually shows Tesamorelin reduced visceral fat by 15.2% while placebo rose 5.0% over 26 weeks in a 412-patient Phase 3 trial; triglycerides fell 50 mg/dL and IGF-1 rose 81.0% [1]. Those are the headline numbers, and they come from a single, tightly-bounded population: adults with HIV-associated lipodystrophy on antiretroviral therapy. The compound is a synthetic 44-amino-acid analogue of human growth-hormone-releasing hormone — GHRH(1-44) — carrying a trans-3-hexenoyl group on its N-terminus (the chain's starting end). That modification blocks DPP-IV (an enzyme that normally chops up natural GHRH within minutes), so the molecule survives long enough to do its job [11]. It does not supply growth hormone. It prompts the pituitary to make and release the body's own, which is why its metabolic profile differs from injected recombinant growth hormone [12]. The effect on the [visceral-fat research](/research) is selective. Subcutaneous fat (the layer beneath the skin) and BMI generally do not change; the deep abdominal depot does. A 2026 meta-analysis of five randomized trials pooled a visceral-fat reduction of MD -27.71 cm² (95% CI -38.37 to -17.06), a hepatic-fat-fraction drop of -4.28%, and a lean-body-mass gain of +1.42 kg, all P<0.001, with no serious adverse events [15]. ## What the benefits look like in studied populations Frame the benefit by the endpoint that was measured. In the pivotal program, the measured outcomes were visceral-fat reduction, lower triglycerides, raised IGF-1, and — in liver-focused trials — reduced hepatic fat. These are HIV-lipodystrophy endpoints, not a general weight-loss promise. Visceral adipose tissue fell 15.2% at 26 weeks and stayed down at roughly -18% through 52 weeks of continued dosing [1][2]. Triglycerides dropped 50 mg/dL versus a 9 mg/dL rise on placebo [1]. The liver-fat signal is covered in detail on the [tesamorelin and liver fat](/liver-fat) page. None of these figures describes a non-HIV population; large general-population fat-loss trials have not been completed [12]. ## Is tesamorelin a steroid? (No — it is a GHRH peptide) Tesamorelin is not a steroid. It is a peptide — a short chain of amino acids — that acts as a growth-hormone-releasing hormone (GHRH) analogue. Steroids are lipid-based molecules built on a four-ring carbon skeleton; tesamorelin is a 44-residue peptide hormone (molecular weight 5,135.9 Da) [11]. Its mechanism is also different in kind. Rather than binding a nuclear hormone receptor as steroids do, tesamorelin binds the GHRH receptor on pituitary somatotroph cells and prompts the gland to secrete the body's own growth hormone, which in turn raises IGF-1 [4]. It amplifies an existing endocrine rhythm; it does not introduce a steroid hormone. ## Is tesamorelin FDA approved? The exact scope Yes, but narrowly. Tesamorelin was approved in the United States in 2010 (NDA 022505) to reduce excess abdominal fat in HIV-infected adults with lipodystrophy [5]. That is the entire approved indication. Every other use — general or cosmetic weight loss, anti-aging, performance enhancement, non-HIV fatty-liver treatment, growth-hormone optimization — is off-label and not FDA-approved. The approval is real and specific; it does not extend beyond the HIV-lipodystrophy population. The full [FDA-approval scope](/about) is set out on the about page. Tesamorelin is also prohibited in sport under the WADA Prohibited List (category S2), in- and out-of-competition. ## How to read this site This is an editorial digest of the published tesamorelin literature, organized as a record. Each finding is logged to its study and tagged with the population it came from. The [dose used in the trials](/dosage), the [half-life and pharmacokinetics](/dosage), and the [side effects and contraindications](/faq) each have their own page. Every quantitative claim resolves to the [full reference list](/references). Where a use falls outside the approved indication, that boundary is marked, not glossed. --- Tesarx files the tesamorelin record as a flat, hard-bordered data sheet — every visceral-fat and IGF-1 figure logged straight to its study, the lone HIV-lipodystrophy approval and the off-label edge ruled in plain view; an exposed-document digest, never a clinic, a pharmacy, or a prescription.