Trial Number
548-25
Condition
Cystic Fibrosis
Participant Age Range
12 years and older
Participant Gender
Any
Enrolling Participants
Yes
Overview
“A Phase 2 Open-Label, Multicenter Study to Assess the Safety and Efficacy of ANG003 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis”
Researchers are testing an investigational treatment called ANG003 in people with cystic fibrosis who have exocrine pancreatic insufficiency (EPI), a condition where the pancreas does not make enough digestive enzymes. This Phase 2 study will compare two dose levels of ANG003 with Creon®, a commonly used pancreatic enzyme replacement therapy, to evaluate safety and effectiveness. Participants will take study medication, complete study visits, and undergo evaluations of digestion, nutritional absorption, gastrointestinal symptoms, and overall health.