An Open Label, Randomized, Multicenter Study of Elafibranor in Children with Nonalcoholic Steatohepatitis.

Nidhi P Goyal,Ali Mencin,Kimberly P Newton,Janis Durelle,Carissa Carrier,Patricia Ugalde-Nicalo,Benoit Noel,Julie Mouton,Dawn Vargas,David Magrez,Bachirou Tadde,Pascal Birman,Brookie M Best,Carol Addy,Jeffrey B Schwimmer

Journal of pediatric gastroenterology and nutrition（2023）

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摘要

Once daily dosing of elafibranor was well tolerated in children with NASH. There was a 37.4% relative reduction from mean baseline ALT in the 120mg group. Decreasing ALT may be associated with improvement in liver histology, thus could be considered a surrogate for histology in early phase trials. These results may support further exploration of elafibranor in children with NASH.

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