TEAEs in excess of placebo included diarrhea and nausea at the initiation of treatment.
TEAEs occurred in 86.5% (open-label 100 mg resmetirom), 86.1% (100 mg resmetirom), 88.4% (80 mg resmetirom) and 81.8% (placebo) of patients. The primary end point was incidence of treatment-emergent adverse events (TEAEs) over 52 weeks and key secondary end points were LDL-C, apoB, triglycerides (over 24 weeks), hepatic fat (over 16 and 52 weeks) and liver stiffness (over 52 weeks). Patients were randomized to three double-blind arms (100 mg resmetirom ( n = 325), 80 mg resmetirom ( n = 327) or placebo ( n = 320)) or open-label 100 mg resmetirom ( n = 171).
MAESTRO-NAFLD-1 was a 52-week randomized, double-blind, placebo-controlled phase 3 trial evaluating the safety of resmetirom in adults with nonalcoholic fatty liver disease and presumed NASH.
Nonalcoholic steatohepatitis (NASH) is a progressive liver disease with no approved treatment.
