Efficacy and safety of apararenone (MT?3995) in patients with nonalcoholic steatohepatitis: A randomized controlled study

Aim To evaluate the efficacy, safety, and tolerability of apararenone 10 mg/day in patients with nonalcoholic steatohepatitis (NASH). Methods In this multicenter, randomized, double-blind, placebo-controlled phase II study, received mg or placebo once daily for 72 weeks. The primary efficacy end-point was percent change serum alanine aminotransferase (ALT) from baseline to 24 weeks after randomization. Secondary end-points included changes liver fibrosis markers. Adverse drug reactions (ADRs) potassium levels were evaluated. Results Forty-eight randomly assigned treatment (placebo, 23; apararenone, 25). ALT at ?3.0% ?13.7% respectively (p = 0.308). group showed greater reductions markers (type IV collagen 7S procollagen-3 N-terminal peptide) noninvasive tests (enhanced score Fibrosis-4 index) all time points versus placebo. percentage improvement 1 point more stage/without fatty disease activity worsening 41.7% 26.1% 0.203). reported three (13.0%) (12.5%) groups, respectively. Serum increased during study decreased near end treatment. Conclusions NASH, effective decreasing levels, improved multiple potential markers, safe well tolerated. Pathological findings anti-inflammatory antifibrotic effects apararenone.