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NCT05461105 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With NASH F3
A Phase 2 study, sponsored by Hepion Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT05461105: Completed Phase 2 study, sponsored by Hepion Pharmaceuticals.
NCT05461105 is a Phase 2 study that has completed, run by Hepion Pharmaceuticals. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05461105, a Phase 2 study, has completed, sponsored by Hepion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a randomized, open-label, parallel-dosing, multi-center study to evaluate the safety and efficacy of rencofilstat as evidenced by assessing changes in the HepQuant Shunt Disease Severity Index Score (DSI), safety labs, and clinical events in adult NASH subjects with compensated Fibrosis stage F 2/3. Antifibrotic biomarker activity will be evaluated on an exploratory basis.
Primary Outcome
Primary Efficacy Endpoint
Interventions
- DRUG rencofilstat, 75 mg
- DRUG rencofilstat, 150mg
- DRUG rencofilstat, 225 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-03-15 |
| Est. Completion | 2023-07-07 |
| Phase | Phase 2 |
What the finished NCT05461105 record still lists
NCT05461105 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which rencofilstat, 75 mg is the first listed.
NCT05461105 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05461105 about?
NCT05461105 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With NASH F3". This is a randomized, open-label, parallel-dosing, multi-center study to evaluate the safety and efficacy of rencofilstat as evidenced by assessing changes in the HepQuant Shunt Disease Severity Index Score (DSI), safety labs, and clinical events in adult NASH subjects with compensated Fibrosis stag...
What is the current status of trial NCT05461105?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2022-03-15. Estimated completion is 2023-07-07.
What interventions are being tested in trial NCT05461105?
The interventions under investigation include: rencofilstat, 75 mg (DRUG), rencofilstat, 150mg (DRUG), rencofilstat, 225 mg (DRUG).
Who is sponsoring clinical trial NCT05461105?
This trial is sponsored by Hepion Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05461105's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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