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

NCT05402371 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-05-03

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, parallel-dosing, multi-center study to evaluate the efficacy and safety of Rencofilstat as evidenced by histopathological improvements in fibrosis in adult NASH subjects with F2 or F3 fibrosis (NASH CRN system). Antifibrotic biomarker activity will be evaluated on an exploratory basis.

Conditions

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

Interventions

DRUG

Rencofilstat

Rencofilstat soft gel capsule

DRUG

Placebo

placebo soft gel capsule

Sponsors & Collaborators

  • Hepion Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen Harrison, MD · Pinnacle Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-15
Primary Completion
2025-05-31
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States
  • France
  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05402371 on ClinicalTrials.gov