Phase 2 Study of ANG003 for Exocrine Pancreatic Insufficiency in Cystic Fibrosis
This study is looking into ANG003, a pancreatic enzyme replacement therapy (PERT, also called "enzymes"), as a possible treatment for exocrine pancreatic insufficiency (EPI). EPI is a condition where your pancreas doesn't make enough enzymes to digest food. You might be able to join if you have EPI due to Cystic Fibrosis (CF) and are at least 12 years old in the US or 18 in the EU, with a confirmed diagnosis of CF and severe EPI. The main goals are to check the safety of ANG003 and see if it works as well as Creon, which is an approved PERT. We don't know the current recruitment status.
- Study design
- This is an interventional study comparing two doses of ANG003 to Creon. It plans to enroll 113 participants.
- What's involved
- You would take either ANG003 or Creon, and your safety will be monitored through adverse events and lab tests for about 80 days. You will also have fat absorption tests at the beginning and after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from Visit 1 to Visit 5, which is anticipated to be an average of 80 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 2 Study to Assess the Safety and Efficacy of ANG003
At a glance
Conditions
Where it's being run
26 sites across 17 statesWho to contact
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What this trial measures
- Adverse events (AEs); Treatment-emergent AEs; Serious AEs; Discontinuation due to AEs; Clinical laboratory valuesFrom Visit 1 to Visit 5, anticipated average 80 days
Adverse events (AEs); Treatment-emergent AEs; Serious AEs; Discontinuation due to AEs; Clinical laboratory values
- Coefficient of Fat Absorption (CFA)Period A (baseline) and Period B 72 hour CFA collection
Mean change from baseline CFA (i.e., Period B CFA minus Period A CFA) assessed for ANG003 Dose A, ANG003 Dose B, and Creon amongst subjects with baseline CFA ≥80%.