Study wrapper · #1303
Semaglutide in Japanese participants with metabolic dysfunction-associated steatohepatitis: a subgroup analysis of the ESSENCE trial.
Editor's note
The headline steatohepatitis-resolution effect in the Japanese subgroup is large and its confidence interval excludes zero, tracking the direction of the full ESSENCE interim result. The fibrosis-improvement endpoint is the weaker signal here: the 7-point difference has a confidence interval crossing zero, which is what one would expect from a subgroup of 78 versus 38 participants and should not be read as evidence of no effect. Readers should regard this as a consistency check on the parent trial rather than independent confirmation, and note that ESSENCE is industry-sponsored, still ongoing to 240 weeks, and that this analysis was not powered for subgroup inference.
Plain-language abstract
In the 116 Japanese participants of the phase 3 ESSENCE trial, once-weekly semaglutide 2.4 mg resolved steatohepatitis without worsening liver scarring in 63.1% of participants versus 36.8% on placebo at 72 weeks. Improvement in fibrosis itself was more modest, 36.5% versus 28.9%, and that difference was not statistically distinguishable from chance. Tolerability in this subgroup looked consistent with the overall trial population.