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NCT05402371 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis
A Phase 2 study of NAFLD and Non-alcoholic Steatohepatitis (NASH), sponsored by Hepion Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT05402371: Active Phase 2 study of NAFLD and Non-alcoholic Steatohepatitis (NASH), sponsored by Hepion Pharmaceuticals.
NCT05402371 is a Phase 2 study of NAFLD and Non-alcoholic Steatohepatitis (NASH) that is active but no longer recruiting, run by Hepion Pharmaceuticals. The registered enrollment target is 120 participants, below the 161-participant average among 26 other NAFLD trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05402371, a Phase 2 study of NAFLD and Non-alcoholic Steatohepatitis (NASH), is active but no longer recruiting, sponsored by Hepion Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
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 |
What the registry record for NCT05402371 still lists
NCT05402371 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 161-participant average among 26 other NAFLD trials with a reported enrollment target (25% lower).
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.
NCT05402371 names 20 study sites across 5 states, led by Florida, Arizona, California.
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, Non-alcoholic Steatohepatitis (NASH), Fibrosis, Liver.
What interventions are being tested in trial NCT05402371?
The interventions under investigation include: Placebo (DRUG), Rencofilstat (DRUG).
Who is sponsoring clinical trial NCT05402371?
This trial is sponsored by Hepion Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05402371's enrollment target sits among peer trials
120 10th of 26 higher than 17 of 26 other NAFLD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NAFLD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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