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A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis
NCT05402371 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Placebo
- DRUG Rencofilstat
Study Locations (20)
Florida
- Synergy Healthcare, LLC — Bradenton
- Tampa Bay Medical Research, Inc. — Clearwater
- Top Medical Research, Inc. — Cutler Bay
- Integrity Clinical Research, LLC — Doral
- Evolution Clinical Trials, Inc. — Hialeah Gardens
- Borland Groover Clinical Research — Jacksonville
- Ocala GI Research — Lady Lake
- Accel Research Sites-Lakeland CRU — Lakeland
- Future Care Solutions, LLC — Miami
Arizona
- Arizona Liver Health-Chandler — Chandler
- Arizona Liver Health — Peoria
- Adobe Clinical Research, LLC — Tucson
- Arizona Liver Health-Tuscon — Tucson
California
- National Research Institute — Huntington Park
- National Research Institute — Los Angeles
- National Research Institute — Panorama City
- National Research Institute — Santa Ana
Arkansas
- Preferred Research Partners, Inc. — Little Rock
- Arkansas Gastroenterology — North Little Rock
Alabama
- Medical Affiliated Research Center — Huntsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-10-15 |
| Est. Completion | 2025-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05402371
The ClinicalTrials.gov registry entry for NCT05402371 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hepion Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with NAFLD appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05402371 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05402371 about?
NCT05402371 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis". 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 ...
What is the current status of trial NCT05402371?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2022-10-15. Estimated completion is 2025-09.
What conditions does trial NCT05402371 study?
This clinical trial studies the following conditions: NAFLD, Fibrosis, Liver, Nonalcoholic Steatohepatitis (NASH). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05402371?
The interventions under investigation include: Placebo (DRUG), Rencofilstat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05402371?
This trial is sponsored by Hepion Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05402371 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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