Objectives
NASH
SECONDARY
The primary objective was to evaluate the safety and tolerability of resmetirom as measured by the incidence of TEAEs over 52 weeks of treatment. The same objective applied to the OL noncirrhotic NASH cohort that enrolled in the trial from the time of initiation to the closure of the 1:1:1:1 randomization (1 July 2020). Key secondary objectives were %CFB to week 24 in LDL-C; %CFB to week 24 in apoB; %CFB to week 16 in hepatic fat (measured by MRI-PDFF); %CFB to week 24 in TGs in the subgroup with baseline TGs ≥ 150 mg dlAdditional secondary objectives were %CFB to week 52 in hepatic fat (measured by MRI-PDFF); %CFB to week 24 in LDL-C in the subgroup with baseline LDL-C ≥ 100 mg dlExploratory outcomes included change from baseline to week 52 in sex hormones (estradiol, follicle-stimulating hormone, luteinizing hormone, testosterone, free testosterone and SHBG); CFB to week 52 in thyroid hormones (FT3, FT4, rT3, FT3/rT3, TSH and thyroxine-binding globulin).