Study wrapper · #528
Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial.
Editor's note
This is a pivotal randomized, double-blind, multicenter, placebo-controlled trial (61 participants) of tesamorelin for liver fat in people with HIV and NAFLD — among the strongest primary evidence for this indication. Researchers reported that over 12 months tesamorelin was associated with a greater reduction in hepatic fat fraction than placebo (absolute -4.1%, a -37% relative reduction), with 35% of the tesamorelin group versus 4% of placebo reaching a hepatic fat fraction below 5%, and no significant differences in fasting glucose or HbA1c. Injection-site complaints were more common but none were judged serious. The randomized, blinded, multicenter design gives this real weight; the sample is modest and the primary endpoint is imaging-based liver fat rather than long-term histologic outcomes, which the authors note require further study.
Plain-language abstract
In this rigorous trial, 61 people with HIV and fatty liver disease were randomly assigned to receive either tesamorelin (2 mg injected daily) or an identical placebo for 12 months, with neither patients nor staff knowing who got which. Tesamorelin was associated with a substantially greater drop in liver fat than placebo — about a 37% relative reduction — and after a year, 35% of the tesamorelin group had liver fat below the threshold that defines fatty liver, versus only 4% on placebo. Blood-sugar measures did not differ meaningfully between groups. People on tesamorelin more often reported reactions where they injected the drug, but none were considered serious. Because the study was randomized, blinded, and run at multiple centers, its findings are relatively trustworthy, though it was fairly small and measured liver fat by scan rather than tracking long-term liver damage.