Losartan for the Treatment of Pediatric Nonalcoholic Fatty Liver Disease

The STOP-NAFLD (Losartan for the Treatment of Pediatric NAFLD) trial was a multicenter, double-masked, placebo-controlled, randomized phase 2 trial designed by the NASH Clinical Research Network to determine whether treatment with losartan improves measures of NAFLD in children. Children between the ages of 8 and 17 years with biopsy-proven NAFLD were eligible for the STOP-NAFLD study. Participants were enrolled and randomized to treatment with either 100 mg of losartan or matching placebo orally once daily for 24 weeks. Improvement in NAFLD at 24 weeks, defined as a decrease in serum alanine aminotransferase (ALT), was assessed as the primary outcome measure. Secondary outcome measures, also assessed at 24 weeks, included relative change in ALT; changes in serum aspartate aminotransferase (AST) and gamma-glutamyl transpeptidase (GGT); change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR); changes in anthropometric measurements, BMI z-score, and serum lipid profiles; and self-reported quality of life.