Assessing a New Investigational Enzyme Replacement Therapy in CF Patients with EPI
Trial Objectives
Exocrine pancreatic insufficiency (EPI), a condition that leads to malnutrition and digestive symptoms, is common among people with cystic fibrosis (CF). Pancreatic enzyme replacement therapy (PERT) is a standard treatment for EPI, but current PERT therapies require taking large doses of medication and do not address all nutrient malabsorption in the digestive tract. Researchers want to know if an investigational oral treatment called ANG003 is safe and to evaluate its effects on nutrient absorption.
During study visits, participants will receive a physical exam and complete questionnaires about their bowel habits and digestion symptoms. On the second and fourth study visits, patients will be asked to eat prepared meals and complete a nutrient absorbance test and have multiple blood samples taken.
Who Can Participate
Adults aged 18 years and older with exocrine pancreatic insufficiency due to cystic fibrosis, who are also on a stable dose of pancreatic enzyme replacement therapy (PERT).
Age: 18+ Gender: Any
Estimated Time Commitment
Six in-person visits and two phone calls, occurring within 23-26 days, two in-person visits will require being in the clinic for up to 12 hours
Payment & Reimbursement
Payment: Provided
Travel Reimbursement: Available
Trial Location
National Jewish Main Campus, Denver, CO
Trial Sponsors
Anagram Therapeutics
Principal Investigators
Jeffrey B. King, MD