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
Phase: Phase 2, Recruiting
First Posted: October
Condition(s): Exocrine Pancreatic Insufficiency (EPI) , Cystic Fibrosis (CF)
NCT Number: NCT07450547
What Is the Purpose of This Study?
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.
Who Can Take Part in This Study?
People who may be eligible are:
- Age 12 and older
- Confirmed and documented diagnosis of cystic fibrosis
- Diagnosed with severe exocrine pancreatic insufficiency (EPI) as defined by a fecal elastase ≤50 μg/g stool measured at Screening by a central laboratory
- Subject has controlled EPI and taking a stable dose of pancreatic enzyme replacement therapy (PERT) for 90 days prior to screening
- Adequate nutritional status measured by body mass index (BMI) defined by:
- BMI ≥25th percentile for children aged 12-17 years
- BMI ≥18.5 kg/m2 for ≥18 years of age
What Will Happen During This Study?
Participants will:
- Take Creon for 14 days. Researchers then measure how much fat the participant absorbs from food.
- Enter a study group based on that result.
- Follow the assigned treatment for about 21 days. People in the group that stops enzymes still take Creon during this period. They then stop enzymes for 4 to 7 days around the final fat absorption test.
Researchers will compare fat absorption before and after treatment using 72-hour stool collections.
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