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Human evidence record ยท Tesamorelin

Tesamorelin and neurocognitive impairment in people with HIV and abdominal obesity

Within-group cognitive score improved numerically with tesamorelin, but the between-group difference was not significant (P=0.673); waist circumference declined more with tesamorelin.

Quick read
Human evidence record

What this study tells us

This was an early human study designed mainly to measure exposure, tolerability or a preliminary signal. Without stronger blinded controls, it should not be treated as definitive proof of benefit.

Who was studied?

Virally suppressed people with HIV, abdominal obesity and neurocognitive impairment

How many?

n=73

What happened?

Within-group cognitive score improved numerically with tesamorelin, but the between-group difference was not significant (P=0.673); waist circumference declined more with tesamorelin.

What stops us overclaiming?

Underpowered, no placebo arm, short duration; does not demonstrate cognitive efficacy.

Need help with terms such as randomized, placebo, endpoint or sample size? Open the glossary โ†’

Key result

Within-group cognitive score improved numerically with tesamorelin, but the between-group difference was not significant (P=0.673); waist circumference declined more with tesamorelin.

Study details

Study designRandomized open-label Phase II trial
PhasePhase II
PopulationVirally suppressed people with HIV, abdominal obesity and neurocognitive impairment
Sample size73
RouteSubcutaneous
Regimen / exposureTesamorelin 2 mg once daily
Duration6 months
ComparatorStandard of care
Primary endpoint / questionChange in neurocognitive performance
Safety resultNo major new safety conclusion can be drawn from the small open-label study.
Key limitationsUnderpowered, no placebo arm, short duration; does not demonstrate cognitive efficacy.
Registry / identifierPMID 39813152