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A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-controlled Study of MGL-3196 in Patients With Non-alcoholic Steatohepatitis

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Trial Profile

A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-controlled Study of MGL-3196 in Patients With Non-alcoholic Steatohepatitis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 01 Jan 2024

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At a glance

  • Drugs Resmetirom (Primary)
  • Indications Non-alcoholic steatohepatitis
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Madrigal Pharmaceuticals

    • Most Recent Events

    • 14 Nov 2023 Results assessing the association between ballooning reduction and steatosis reduction in the resmetirom versus placebo group using second harmonic generation (SHG)/two-photon excited fluorescence (TPEF) microscopy imaging of paired biopsy samples with artificial intelligence (AI)-based algorithms presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases
    • 24 Jun 2023 Results (from studies NCT02443116 and NCT02912260) assessing the concomitant changesof qFibrosis (qF) with qSteatosis (qS) and qBallooning (qB) in zonalregions to evaluate the impact of hepatic fat and LV reduction on fibrosis changes presented at the European Association for the Study of the Liver Congress 2023
    • 24 Jun 2023 Results of train artificial intelligence models (n=101) to characterize cell types present in non-alcoholic steatohepatitis and identify morphologic correlates of liver volume reduction in biopsies from the Phase 2 NCT02912260 trial of resmetirom for treatment of NASH, presented at the European Association for the Study of the Liver Congress 2023.
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