Study 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.
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