Human evidence record · Tesamorelin

Tesamorelin for non-alcoholic fatty liver disease in people with HIV

Tesamorelin reduced liver fat by an absolute 4.1 percentage points versus placebo, about a 37% relative reduction; 35% versus 4% reached hepatic fat fraction <5%.

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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 hepatic fat fraction >=5%

How many?

n=61

What happened?

Tesamorelin reduced liver fat by an absolute 4.1 percentage points versus placebo, about a 37% relative reduction; 35% versus 4% reached hepatic fat fraction <5%.

What stops us overclaiming?

HIV-associated NAFLD population; this is not evidence for general weight loss or non-HIV NAFLD treatment.

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Key result

Tesamorelin reduced liver fat by an absolute 4.1 percentage points versus placebo, about a 37% relative reduction; 35% versus 4% reached hepatic fat fraction <5%.

Study details

Study designRandomized, double-blind, placebo-controlled multicenter trial

PopulationAdults with HIV and hepatic fat fraction >=5%

Sample size61

RouteSubcutaneous

Regimen / exposureTesamorelin 2 mg once daily

Duration12 months blinded + 6-month open-label extension

ComparatorPlacebo

Primary endpoint / questionChange in hepatic fat fraction

Safety resultInjection-site complaints were more frequent; fasting glucose/HbA1c changes were not significantly different at 12 months.

Key limitationsHIV-associated NAFLD population; this is not evidence for general weight loss or non-HIV NAFLD treatment.

Registry / identifierPMID 31611038 / NCT02196831

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