Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease

Progression of Fatty Liver Disease in Children Receiving Standard of Care Lifestyle Advice

“…Trials of novel therapies are urgently needed to identify efficacious and accessible interventions for children failing to respond to lifestyle counseling. 38…”

Nonalcoholic Fatty Liver Disease in Children: Unique Considerations and Challenges

“…179 Given the unique physiological and histologic features of pediatric NASH, along with the complex interplay between the environment and genetics, it should not be assumed that children will have similar disease progression or response to interventions found to be effective in adults. 180 Thus, it is imperative that pediatric trials be conducted with rigor, and in near tandem with those demonstrating near-term efficacy in adults. Trials in 169 RCT Improvement in ALT and US-measured steatosis, both NS Consider in children with biopsy-proven NASH without diabetes.…”

Perspectives on youth‐onset nonalcoholic fatty liver disease

“…121 It is imperative that there are also independent paediatric trials that are designed with certain considerations in mind, such as the different histological subtypes in children, and the potential confounding by age, sex and pubertal stage. 122…”

“…Importantly, the majority of pharmacological intervention trials have been limited to adults, and thus far surgical intervention studies focused specifically on outcomes in obese children and adolescents with NAFLD are lacking 121 . It is imperative that there are also independent paediatric trials that are designed with certain considerations in mind, such as the different histological subtypes in children, and the potential confounding by age, sex and pubertal stage 122 …”