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NCT05719311 · ClinicalTrials.gov registry record · Phase 2
Study to Assess an Enteric Microgranule Formulation of Adrulipase in Patients With Cystic Fibrosis
A Phase 2 study, sponsored by Entero Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT05719311: Completed Phase 2 study, sponsored by Entero Therapeutics.
NCT05719311 is a Phase 2 study that has completed, run by Entero Therapeutics. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05719311, a Phase 2 study, has completed, sponsored by Entero Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
Some cystic fibrosis patients are unable to digest food and absorb nutrition appropriately as they have a condition known as exocrine pancreatic insufficiency (EPI). Currently, these patients take pancreatic enzymes that are obtained from pig pancreas to aid the digestion of food. The goals of this clinical study are to evaluate the safety and efficacy of a novel formulation of a non-porcine lipase, called adrulipase, in patients with EPI due to cystic fibrosis. The main question\[s\] the study aims to answer are: 1. Is the novel formulation of adrulipase safe to use at the doses being evaluated in the clinical study. 2. Is adrulipase as effective, or more effective, compared to the pig enzymes the patients currently use. Researchers will compare the results obtained with adrulipase to how the patients typically respond to their pig enzymes to see if adrulipase helps patients digest fats adequately and if their stomach feels good (signs and symptoms of malabsorption).
Primary Outcome
Number of subjects reporting 1 or more adverse events.
Interventions
- DRUG adrulipase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2023-07-28 |
| Phase | Phase 2 |
What the finished NCT05719311 record still lists
NCT05719311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which adrulipase is the first listed.
NCT05719311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05719311 about?
NCT05719311 is a clinical study titled "Study to Assess an Enteric Microgranule Formulation of Adrulipase in Patients With Cystic Fibrosis". Some cystic fibrosis patients are unable to digest food and absorb nutrition appropriately as they have a condition known as exocrine pancreatic insufficiency (EPI). Currently, these patients take pancreatic enzymes that are obtained from pig pancreas to aid the digestion of food. The goals of this ...
What is the current status of trial NCT05719311?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2023-02-01. Estimated completion is 2023-07-28.
What interventions are being tested in trial NCT05719311?
The interventions under investigation include: adrulipase (DRUG).
Who is sponsoring clinical trial NCT05719311?
This trial is sponsored by Entero Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05719311's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 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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