Exploratory outcome
hyperthyroidism, hypothyroidism
HYPERTHYROIDISM, MINOR, HYPOTHYROIDISM, LIVER
ALT increases of ≥3 × ULN occurred in fewer patients in the resmetirom arms compared to the placebo arm (0.5% (OL 100 mg resmetirom), 0.3% (DB 100 mg resmetirom) and 0.6% (DB 80 mg resmetirom) versus 1.9% (placebo)). As a marker of potential efficacy, liver enzymes were reduced from baseline over time in the resmetirom arms compared to placebo. Safety observations related to potential thyroid axis or thyroid hormone effects showed no increase in signs or symptoms of hypothyroidism or hyperthyroidism relative to placebo. At week 52, minor reductions in body weight from baseline were noted in all treatment arms with no significant difference between the DB resmetirom and placebo arms (Extended Data Table Minimal reductions from baseline in prohormone FT4 levels were observed in the resmetirom arms. No effects on active hormone free triiodothyronine (FT3) or thyroid-stimulating hormone (TSH) were noted in the resmetirom arms. Sex hormone levels after 52 weeks of resmetirom treatment are shown in Extended Data Table Liver volume was evaluated in the OL 100 mg resmetirom arm at week 52. Liver volume was reduced from the baseline by a mean of 21% and 23% following 16 and 52 weeks of resmetirom treatment, respectively (Extended Data Fig. 