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Human evidence record · Tesamorelin

Tesamorelin for excess abdominal fat in HIV

Visceral adipose tissue decreased about 15.2% with tesamorelin versus an increase of about 5% with placebo.

Quick read
Human evidence record

What this study tells us

Participants were assigned to comparison groups by chance, usually with placebo and/or blinding to reduce bias. This is a strong design for testing cause and effect, but the population, duration and endpoints still limit what can be concluded.

Who was studied?

Adults with HIV and excess abdominal fat

How many?

n=412

What happened?

Visceral adipose tissue decreased about 15.2% with tesamorelin versus an increase of about 5% with placebo.

What stops us overclaiming?

Strong evidence for a narrow HIV-associated lipodystrophy indication; not proof of general weight-loss efficacy.

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Key result

Visceral adipose tissue decreased about 15.2% with tesamorelin versus an increase of about 5% with placebo.

Study details

Study designRandomized double-blind placebo-controlled trial
PhasePhase III
PopulationAdults with HIV and excess abdominal fat
Sample size412
RouteSubcutaneous
Regimen / exposure2 mg once daily
Duration26 weeks
ComparatorPlacebo
Primary endpoint / questionVisceral adipose tissue
Safety resultGlucose/IGF-1 monitoring and adverse-event considerations are indication-specific.
Key limitationsStrong evidence for a narrow HIV-associated lipodystrophy indication; not proof of general weight-loss efficacy.
Registry / identifierPMID 18057338