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NCT04152473 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Oral Proglumide for NASH
A Phase 1 study, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT04152473: Completed Phase 1 study, sponsored by Georgetown University.
NCT04152473 is a Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04152473, a Phase 1 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This study is an open labelled Phase I/II clinical trial, designed to evaluate the safety and efficacy of an oral cholecystokinin (CCK) receptor antagonist, proglumide, at escalating doses in subjects with NASH. An extended use protocol has been approved for subjects completing this study that show benefit or are at risk of Liver disease progression to continue on Proglumide at 1200 mg / day for an additional 3-9 months. Subjects in the extended protocol will have telephone visits monthly and in the research unit every 3 months for safety lab tests and research blood for fibrosis analysis.
Primary Outcome
Number of participants with drug related Toxicity will follow standard Common Terminology Criteria for Adverse Events v.5,(CTCAE) criteria protocols. Toxicity is graded according to severity for symptoms obtained on the visit review of symptoms and according to blood tests collected at each scheduled visit
Interventions
- DRUG Proglumide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-12-13 |
| Est. Completion | 2022-09-09 |
| Phase | Phase 1 |
What the finished NCT04152473 record still lists
NCT04152473 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Proglumide is the first listed.
NCT04152473 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04152473 about?
NCT04152473 is a clinical study titled "Safety and Tolerability of Oral Proglumide for NASH". This study is an open labelled Phase I/II clinical trial, designed to evaluate the safety and efficacy of an oral cholecystokinin (CCK) receptor antagonist, proglumide, at escalating doses in subjects with NASH. An extended use protocol has been approved for subjects completing this study that show...
What is the current status of trial NCT04152473?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2019-12-13. Estimated completion is 2022-09-09.
What interventions are being tested in trial NCT04152473?
The interventions under investigation include: Proglumide (DRUG).
Who is sponsoring clinical trial NCT04152473?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04152473's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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