Madrigal ’s MGL-3196 Achieves Primary Endpoint in Patients with Biopsy-proven Non-alcoholic Steatohepatitis (NASH) in Phase 2 Clinical Trial
-- Statistically significant improvement in the relative decrease in liver fat in patients treated with MGL-3196 compared with placebo, determined by magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF) at 12-weeks, the primary end point in this Phase 2 proof-of-concept trial–
-- Statistically significantly more MGL-3196 than placebo treated patients achieved clinically relevant (at least 30%) liver fat reduction at 12 weeks relative to baseline MRI-PDFF–
-- Statistically significant improvements in drug-treatment group compared to placebo in low-density lipoprotein cholesterol (LDL-C), triglycerides and lipoprotein (a) (Lp(a)); these lipids when elevated are associated with increased cardiovascular risk–
-- Statistically significant improvements in liver enzymes in drug-treatment group, with very good all subject tolerability, few serious adverse events, none related to MGL-3196–
-- Clinical trial continues blinded with potential for correlating improvement in non-invasive imaging test (MRI-PDFF at 12 and 36 weeks) with improvement in repeat liver biopsy obtained at 36 weeks–
- Published: 06 December 2017
- Written by Editor