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A Phase 2B, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rencofilstat in Adult Subjects With Nonalcoholic Steatohepatitis and Advanced Liver Fibrosis

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Trial Profile

A Phase 2B, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rencofilstat in Adult Subjects With Nonalcoholic Steatohepatitis and Advanced Liver Fibrosis

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 08 May 2024

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At a glance

  • Drugs Rencofilstat (Primary)
  • Indications Hepatic fibrosis; Non-alcoholic steatohepatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ASCEND; ASCEND NASH
  • Sponsors Hepion Pharmaceuticals

    • Most Recent Events

    • 02 May 2024 Status changed from recruiting to active, no longer recruiting.
    • 19 Apr 2024 According to Hepion Pharmaceuticals media release, to date, approximately 80 subjects have completed their Day 365 visits and are evaluable for both safety and efficacy. An additional 40 subjects will provide significant safety data for evaluation. These patients will be added to our existing safety database.
    • 19 Apr 2024 According to Hepion Pharmaceuticals media release, the company has initiated wind down activities for this trial. Given the number of enrolled NASH patients to date and the low probability of generating relevant efficacy data to support a registrational trial with our current cash resources. patients are transitioned out of the trial in a safe and compliant manner. There were no safety concerns observed for rencofilstat in the ASCEND-NASH trial.

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