Tesamorelin
Synthetic analog of growth-hormone-releasing factor.
Editorial review: August 13, 2026Evidence snapshot
This drawer marks papers. It is not a plan, a dose, or a source. A paper is a bounded report. It is not a protocol. Grades name the object. They are not a safety rating.
The labeled use — reduction of excess abdominal fat in HIV-infected adults with lipodystrophy — lives in Status. It is not reprinted here as a plan. These papers are not a general fat-loss claim.
Bottom line
Tesamorelin has phase 3 human trials for visceral abdominal fat in people with HIV and abdominal fat accumulation. That is the object. It is not general weight loss, not a non-HIV population, and not a proof that liver-fat change is the labeled claim. Liver-fat was measured in later, smaller work. Mark those papers as extra to the VAT claim.
Papers
Approved indication
PMID 18057338 — Falutz 2007
Tested: tesamorelin versus placebo for visceral adipose tissue in HIV-infected adults with abdominal fat accumulation (phase 3).
Does not show: fat loss in people without this HIV-associated abdominal fat object, or a liver-fat label.
PMID 20101189 — Falutz 2010
Tested: confirmatory phase 3, tesamorelin versus placebo for abdominal fat in HIV-infected adults, with a safety extension.
Does not show: a general obesity trial, or that extension safety is the same as a new population.
PMID 20554713 — Falutz 2010 pooled
Tested: pooled analysis of two phase 3 placebo-controlled trials (n=806) for excess abdominal fat in HIV-infected adults, with extension safety.
Does not show: a new independent pivotal trial. This is the two phase 3 studies read together.
PMID 25038357 — Stanley 2014
Tested: tesamorelin versus placebo in 50 antiretroviral-treated HIV-infected adults with abdominal fat accumulation. Co-primary endpoints: visceral adipose tissue and liver fat.
Does not show: a large pivotal VAT trial (that is Falutz). Liver-fat change is not the labeled claim. Small sample.
PMID 38905488 — Russo 2024
Tested: tesamorelin versus placebo in a 12-month subgroup of people with HIV on integrase-inhibitor regimens, nested in a MASLD trial (completers: 15 tesamorelin, 16 placebo). Endpoints included visceral fat and hepatic fat.
Does not show: a pivotal VAT trial. Not a substitute for Falutz. Liver-fat here is off-label relative to the labeled VAT claim. Small INSTI subgroup.
What is not established
General fat loss. Non-HIV obesity. Liver-fat as the labeled object. Integrase-inhibitor era data are a small add-on, not a new basis. A non-trial product is not the phase 3 material.
Selected sources
Reported experiences
Abdominal fat, body composition
Reported topics are not established benefits.Risks and unknowns
Glucose effects, swelling, joint discomfort, injection reactions, contraindications
Compare experiences with care.
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