A 52-week randomized, double-blind, placebo-controlled phase III trial (MAESTRO-NAFLD-1) evaluated the safety of resmetirom in adults with nonalcoholic fatty liver disease and presumed nonalcoholic steatohepatitis. Patients were randomly assigned to either 100 mg resmetirom, 80 mg resmetirom or placebo, or open-label 100 mg resmetirom. Resmetirom was safe and well tolerated (no difference in the primary endpoint of incidence of treatment-emergent adverse events between groups) and key secondary endpoints demonstrated significant reductions in atherogenic lipid levels (LDL-cholesterol, apolipoprotein B and triglycerides), hepatic fat (at 16 weeks and 52 weeks) and liver stiffness (over 52 weeks) in the 80 mg and 100 mg resmetirom groups versus placebo.