# Tesamorelin: The GHRH-Analogue Trials, Read as a Clinical Record > Tesamorelin is a GHRH(1-44) analogue approved in 2010 only for HIV-associated lipodystrophy. A cited digest of the visceral-fat and liver-fat trials, with the off-label line drawn study by study. Approved in 2010 for one narrow indication, with a clean deck of trial numbers and a sharp line between what the studies established and what stays off-label. Every figure here is cited. ## The short version Tesamorelin is a lab-made copy of GHRH (the brain's own "make growth hormone" signal), tweaked so it lasts longer in the blood. It nudges your pituitary gland to release your own growth hormone, which then raises IGF-1 (a growth signal the liver makes when growth hormone rises) and burns off deep belly fat. In trials it cut visceral fat (the deep fat packed around the organs) by about 15% and liver fat by about a third. It is approved by the FDA for only one thing — excess belly fat in people with HIV — and everything else is unproven. This page summarizes what the studies actually measured. ## What the tesamorelin literature has established In the pivotal 26-week trial of 412 HIV patients with abdominal fat accumulation, tesamorelin 2 mg/day reduced visceral adipose tissue — the metabolically active fat packed around the organs — by 15.2%, while placebo rose 5.0% [1]. Triglycerides fell 50 mg/dL against a 9 mg/dL rise on placebo, and IGF-1 rose 81.0% [1]. The effect held: across the 52-week program, visceral fat reduction was sustained at 18% below baseline (P<0.001) [2]. The finding is selective. Subcutaneous fat (the layer beneath the skin) was preserved, and body mass index did not move much — tesamorelin redistributed fat rather than driving general weight loss [1]. A 2026 meta-analysis of five randomized trials in HIV-associated lipodystrophy put the pooled visceral-fat reduction at -27.71 cm2 (95% CI -38.37 to -17.06) and the pooled hepatic-fat-fraction reduction at -4.28%, both without serious adverse events [12]. This is an unusually clean evidence deck for the peptide class: two pivotal Phase 3 trials, a JAMA hepatic-steatosis trial, a Lancet HIV fatty-liver trial, a dedicated diabetes-safety trial, and a 2024 trial in the modern integrase-inhibitor era. What stays unestablished is also clear, and this site marks both. To see the receptor cascade behind these numbers, read [how tesamorelin works](/research). ## What tesamorelin is used for Ask what is tesamorelin used for, and the labeled answer is a single line. Tesamorelin was approved in the United States in 2010 (NDA 022505) for one purpose: to reduce excess abdominal fat in HIV-infected adults with antiretroviral-related lipodystrophy [5]. Lipodystrophy is a metabolic complication of HIV and its therapy in which fat redistributes abnormally, accumulating in the abdomen. That is the approved indication, full stop. Every other use studied or discussed — general or cosmetic fat loss, anti-aging, athletic performance, non-HIV fatty liver disease — is off-label and investigational [5]. Non-HIV human data are limited: a mechanistic study in 13 healthy men [4] and a cognition trial in older adults. No large general-population fat-loss trial has been completed. A 2026 review of injectable peptides noted tesamorelin has no supporting orthopaedic evidence and that off-label musculoskeletal use rests on unestablished data [11]. This digest covers research-grade tesamorelin supplied for laboratory study, not a finished medicine, and gives no dosing guidance for people. ## Is tesamorelin FDA approved? Yes, but narrowly. Tesamorelin was approved by the FDA in 2010 under NDA 022505, and the NIH LiverTox monograph confirms the approval was specifically to reduce excess abdominal fat in HIV-infected patients with antiretroviral-related lipodystrophy [5]. It is a genuine prescription drug with that one labeled indication. The scope is the whole point. The approval does not extend to general weight loss, body recomposition, anti-aging, cognitive enhancement, or fatty liver disease outside HIV. Those applications are off-label and not FDA-approved, however mechanistically plausible they may sound [5]. The 2024 trial in integrase-inhibitor-treated HIV patients extended the evidence within the HIV setting, not beyond it [10]. The distinction — approved for HIV lipodystrophy, off-label everywhere else — is the single most important fact on this page. ## Is tesamorelin safe? A note on the recorded profile The NIH LiverTox monograph assigns tesamorelin a likelihood score of E — unlikely to cause clinically apparent liver injury — with no attributable cases and no de novo serum-enzyme elevations in trials [5]. Trial-recorded effects relate to growth-hormone-axis stimulation: injection-site reactions and modest glucose changes that were not clinically significant over 52 weeks [2]. The honest cautions are specific. Because tesamorelin raises IGF-1, a growth factor, active malignancy is a labeled contraindication, and long-term oncologic-safety data are limited [5]. Pregnancy is contraindicated; animal organogenesis studies showed hydrocephaly in offspring. Glucose monitoring is warranted in people with prediabetes or dysglycemia. Tesamorelin is also prohibited in sport under the WADA list (category S2), in- and out-of-competition. The full [reported side effects](/research) and contraindications are set out on the research page. ## Where the evidence stops A digest that leads with strong numbers owes the reader the boundary too. Three limits define the tesamorelin record. First, the benefit is not permanent: visceral fat reaccumulates within weeks of stopping, so the effect depends on continued dosing [2]. Second, the population is narrow — the efficacy trials are in HIV-positive adults on antiretroviral therapy, and generalization to non-HIV populations is mechanistically plausible but not established by a large trial [5]. Third, the liver findings, while reproducible, are measured as hepatic fat fraction; longer-term effects on liver-tissue structure need further study, as the trial authors noted [6]. This is why the [reported side effects](/research) and the [tesamorelin and liver fat](/liver-fat) pages keep the same discipline as this one: precise about what the trials measured, explicit about where the data stop, and clear that research-grade tesamorelin is not an approved medicine to self-administer. The full [reference list](/references) backs every figure on the site. --- A clear-light reading of the tesamorelin record — every trial figure logged at the snow-line where the approved HIV-lipodystrophy use ends and the off-label questions begin; a luminous reference plate, not a clinic, a pharmacy, or a prescription.