Phase 2 Study to Assess the Safety and Efficacy of ANG003

Recruiting now · Phase 2

Conditions studied: Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)

In brief

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.

Key facts

Study ID

NCT07450547

Run by

Anagram Therapeutics, Inc.

People needed

113

Starts

2026-04-24

Expected to finish

2027-07-01

Last updated by the study team

2026-08-04

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects aged ≥12 years from the date of informed consent in the US and aged ≥18 years in the EU
• Confirmed and documented diagnosis of CF
• Diagnosed with severe 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

You may not qualify if…

• History of fibrosing colonopathy or recurring distal intestinal obstructive syndrome within 6 months of Screening.
• History of lung or liver transplant, listing for organ transplant or significant bowel resection within the last 6 months. Subjects with a history of resection that does not result in short bowel syndrome are eligible.
• Known hypersensitivity or other severe reaction to any ingredient of the investigational product (IP), Creon, or the stool marker (FD\&C Blue #2).
• Any chronic diarrheal illness unrelated to pancreatic insufficiency, actively being treated for small intestinal bacterial overgrowth, requiring use of naso-gastric, J-tube, G-tube, and/or enteral feeding for the study duration, Clostridioides difficile infection within 6 months prior to Screening, or severe constipation defined as <1 bowel movement/week.

Where it is running

• Children's Hospital Medical Center of Akron — Akron, Ohio, United States (enrolling)
• University of Michigan, Michigan Medicine — Ann Arbor, Michigan, United States (enrolling)
• University of Kentucky — Lexington, Kentucky, United States (enrolling)
• Toledo Children's Hospital — Toledo, Ohio, United States (enrolling)
• Hershey Medical Center Pennsylvania State University — Hershey, Pennsylvania, United States (enrolling)
• Rutgers - Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (enrolling)
• University of Texas Southwestern / Children's Health — Dallas, Texas, United States (enrolling)
• The Cystic Fibrosis Institute — Glenview, Illinois, United States (enrolling)
• University of Wisconsin — Madison, Wisconsin, United States (enrolling)
• Long Beach Memorial Medical Center — Long Beach, California, United States (enrolling)
• Wayne State University Harper University Hospital — Detroit, Michigan, United States
• New York Medical College at Westchester Medical Center — Valhalla, New York, United States
• Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Nationwide Children's Hospital, Columbus — Columbus, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Adult Cystic Fibrosis Center at the University of Utah — Salt Lake City, Utah, United States
• Froedtert & Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Center for Cystic Fibrosis at Keck Medical Center of USC — Los Angeles, California, United States
• National Jewish Health — Denver, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Central Florida Pulmonary Group — Orlando, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• MaineHealth Pediatric Specialty Care — Portland, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.