Liver enzymes reductions from baseline over time in resmetirom treated patients in a Phase 3 study, MAESTRO-NASH

Background: Resmetirom is indicated for treatment of MASH with stages F2 to F3 fibrosis. Liver enzyme data from the 52-week MAESTRO-NASH study was analyzed in patients on resmetirom co-administered with a statin, or who were not co-administered a statin.

Methods: Patients on 80 or 100 mg were monitored for changes from baseline in ALT, AST, and GGT for 52 weeks and changes in liver enzymes were assessed by statin treatment at baseline.

Results: A total of 473 (49.0% of 966) patients including 23.1% atorvastatin, 0.7% lovastatin, 0.3% pitavastatin, 6.5% pravastatin, 11.8% rosuvastatin, and 64 (6.6%) simvastatin were assessed. 13% were on high-intensity statin therapy (rosuvastatin 20 mg, atorvastatin 40 mg) and 36% on moderate-to-low-intensity statins. 46.2% patients received resmetirom 80 mg, 51.4% resmetirom 100 mg, and 49.2% received placebo. Patients on statins had ALT and AST at baseline than those not on statins. There was a mild and transient increase in AST and ALT at Week 4 in patients on statins vs. not on statins (did not exceed the level of ALT or AST at 4 weeks in patients not on statins). Elevations resolved by Week 8. At Week 48, in patients with ALT≥30 at baseline ALT declined 20% and 24% on 80 and 100 mg; respectively, in patients on statins and declined by 37% and 43% at 80 and 100 mg; respectively, in patients not on statins.

Conclusions: Liver enzymes declined significantly in resmetirom treated patients relative to placebo beginning at Week 12.

Publication History

Article published online:
20 January 2025