drugset / Trial / NCT07450547
Phase 2 Study to Assess the Safety and Efficacy of ANG003
RandomizedParallel-groupSingle-blindTreatment
Summary
In this study, ANG003, a pancreatic enzyme replacement therapy (PERT; commonly called "enzymes"), is being investigated as a potential treatment for exocrine pancreatic insufficiency (EPI). People with EPI due to Cystic Fibrosis (CF) may be eligible to participate in this study. The primary objective of this study is to evaluate the safety of ANG003 and see if it works as well compared to Creon, an approved PERT.
Timeline
- Start
- 2026-04-24
- Primary completion
- 2027-07
- Completion
- 2027-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ANG003 | Protein / enzyme biologic | 160000 iu | — |
| Subject | ANG003 | Protein / enzyme biologic | 240000 iu | — |
| Comparator | Pancrelipase | Protein / enzyme biologic | — | — |