Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)

Summary

The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy).

Timeline

Start

2020-06-15

Primary completion

2024-01-23

Completion

2024-02-21

Publications

• Wong VW, Amin NB, Takahashi H, Darekar A, Tacke F, Kiszko J, Rodriguez H, Nakajima A, Alkhouri N, Charlton M, Anstee QM. Efficacy and safety of ervogastat alone and in combination with clesacostat in patients with biopsy-confirmed metabolic dysfunction-associated steatohepatitis and F2-F3 fibrosis (MIRNA): results from a phase 2, randomised, double-blind, double-dummy study. Lancet Gastroenterol Hepatol. 2025 Oct;10(10):924-940. doi: 10.1016/S2468-1253(25)00128-1. Epub 2025 Jul 31.
• Amin NB, Darekar A, Anstee QM, Wong VW, Tacke F, Vourvahis M, Lee DS, Charlton M, Alkhouri N, Nakajima A, Yunis C. Efficacy and safety of an orally administered DGAT2 inhibitor alone or coadministered with a liver-targeted ACC inhibitor in adults with non-alcoholic steatohepatitis (NASH): rationale and design of the phase II, dose-ranging, dose-finding, randomised, placebo-controlled MIRNA (Metabolic Interventions to Resolve NASH with fibrosis) study. BMJ Open. 2022 Mar 30;12(3):e056159. doi: 10.1136/bmjopen-2021-056159.

Drugs

Indications