drugset / Trial / NCT07450547

Phase 2 Study to Assess the Safety and Efficacy of ANG003

NCT07450547

Phase 2 Recruiting 113 enrolled Anagram Therapeutics, Inc.
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

EvaluationDrugModalityDoseRoute
Subject ANG003 Protein / enzyme biologic 160000 iu
Subject ANG003 Protein / enzyme biologic 240000 iu
Comparator Pancrelipase Protein / enzyme biologic