NCT07450547

Phase 2 Study to Assess the Safety and Efficacy of ANG003

A Phase 2, Multicenter, Randomized, Active-controlled Study to Assess the Safety and Efficacy of ANG003 at Two Different Dose Levels in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 113 (estimated)
• Sponsor: Anagram Therapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Exocrine Pancreatic Insufficiency (EPI)
• Cystic Fibrosis (CF)

Interventions

Type	Name	Description
DRUG	ANG003 Dose A	160,000 u\* lipase, 105,000 u\* protease, and 11,600 u\* amylase per dose (\*units are comparable to United States Pharmacopeiea \[USP\])
DRUG	ANG003 Dose B	240,000 u\* lipase, 105,000 u\* protease, and 11,600 u\* amylase per dose (\*units are comparable to United States Pharmacopeiea \[USP\])
DRUG	Creon	The commercially available pPERT Creon will be the active comparator in the study. Subjects will be instructed to take Creon according to the package insert and PI direction.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2026-03-04
• Last updated: 2026-03-04

Regulatory

• FDA-regulated drug study