Phase 1b Study Reports Liver-Fat Reduction With Intermittent Miricorilant

Miricorilant, an oral selective glucocorticoid receptor modulator, was evaluated in a phase 1b study involving 70 patients with presumed metabolic dysfunction-associated steatohepatitis (MASH). Participants received daily doses of 30–150 mg or intermittent doses of 100–200 mg once, twice, or three times weekly for 12 or 24 weeks. Outcomes included liver fat content (LFC), liver and fibrosis markers, and safety events.

Across regimens, relative LFC reductions ranged from 10.1% to 76.6%. The 100-mg twice-weekly group had a mean 28.2% reduction at week 12, alongside changes in alanine aminotransferase (−3.8 U/L) and aspartate aminotransferase (−6.0 U/L). Lipid, glycemic, and fibrosis biomarkers showed numerical improvements in this group. Treatment-emergent adverse events led to interruption and discontinuation in 12.9% of patients each (nine patients for each outcome); aminotransferase elevations were commonly associated with rapid LFC reductions and daily dosing.

The authors identified intermittent 100-mg twice-weekly dosing as having the best benefit-risk profile in this study. These early findings rely on liver fat and biomarker outcomes and do not establish clinical benefit. The regimen is being evaluated in the phase 2b MONARCH study (NCT06108219).