ANG003 Enzyme Therapy for Pancreatic Insufficiency in People With Cystic Fibrosis
Compares ANG003 with Creon in people with cystic fibrosis and pancreatic insufficiency.
Plain-language title generated from the registry record
Registry title: Phase 2 Study to Assess the Safety and Efficacy of ANG003
Key facts
- Where
- Akron, Ann Arbor, Atlanta, Boston, Cleveland, Columbus, Dallas, Denver, Detroit, Gainesville, Glenview, Hershey, Iowa City, Kansas City, Lexington, Long Beach, Los Angeles, Madison, Milwaukee, Minneapolis, New Brunswick, Orlando, Pittsburgh, Portland, Salt Lake City, Toledo, and Valhalla, United StatesSee the 28 sites
- Phase
- Phase 2
Where in United States
- Children's Hospital Medical Center of AkronAkron, United StatesTaking people
- University of Michigan - Michigan MedicineAnn Arbor, United StatesTaking people
- Emory-Children's Healthcare of Atlanta Cystic Fibrosis CenterAtlanta, United StatesTaking people
- Boston Children's HospitaBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical CenterCleveland, United StatesTaking people
- Nationwide Children's Hospital, ColumbusColumbus, United StatesTaking people
- University of Texas Southwestern, Children's HealthDallas, United StatesTaking people
- National Jewish HealthDenver, United StatesTaking people
- Wayne State University Harper University HospitalDetroit, United StatesTaking people
- University of FloridaGainesville, United StatesNot yet recruiting
- The Cystic Fibrosis InstituteGlenview, United StatesTaking people
- Hershey Medical Center Pennsylvania State UniversityHershey, United StatesTaking people
- University of IowaIowa City, United StatesNot yet recruiting
- University of Kansas Medical CenterKansas City, United StatesTaking people
- University of KentuckyLexington, United StatesTaking people
- Long Beach Memorial Medical CenterLong Beach, United StatesTaking people
- Center for Cystic Fibrosis at Keck Medical Center of USCLos Angeles, United StatesTaking people
- University of WisconsinMadison, United StatesTaking people
- Froedtert & Medical College of WisconsinMilwaukee, United StatesNot yet recruiting
- University of MinnesotaMinneapolis, United StatesTaking people
- Rutgers, Robert Wood Johnson Medical SchoolNew Brunswick, United StatesTaking people
- Central Florida Pulmonary GroupOrlando, United StatesNot yet recruiting
- University of Pittsburgh Medical CenterPittsburgh, United StatesNot yet recruiting
- MaineHealth Pediatric Specialty CarePortland, United StatesNot yet recruiting
- Adult Cystic Fibrosis Center at the University of UtahSalt Lake City, United StatesTaking people
- Toledo Children's HospitalToledo, United StatesTaking people
- New York Medical College at Westchester Medical CenterValhalla, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Anagram Therapeutics, Inc.
- Trial code
- NCT07450547EU 2025-524569-25-00
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; 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.