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A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis

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NCT05402371

Sponsored by Hepion Pharmaceuticals, Inc. (industry) · HEPA — their whole pipeline →.

Phase
Phase 2
Status
Unknown status
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
120actual
Sites
41
Countries
France, Mexico, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2022-10-15actualWhen the study began enrolling
Primary completionMay 2025estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionSep 2025estimatedThe whole study's end, after follow-up
First posted2022-06-02actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2024-05-03actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Nonalcoholic Steatohepatitis (NASH)
  • Fibrosis, Liver
  • NAFLD

Interventions

  • Drug: Rencofilstat — also filed as CRV431
  • Drug: Placebo

Primary outcome

what the primary-completion date above is the date OF
Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) OR NASH resolution without worsening of fibrosis.
measured dosing period of 1 year with 1 month observation and follow up period

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