RECRUITING Phase 2 ClinicalTrials.gov

Phase 2 Study to Assess the Safety and Efficacy of ANG003

Sponsor: Anagram Therapeutics, Inc. • ClinicalTrials.gov ID: NCT07450547

Registry updated: 2026-10-06

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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.

Interventions

ANG003 Dose A (Drug)
160,000 u\* lipase, 105,000 u\* protease, and 11,600 u\* amylase per dose (\*units are comparable to United States Pharmacopeiea \[USP\])
ANG003 Dose B (Drug)
240,000 u\* lipase, 105,000 u\* protease, and 11,600 u\* amylase per dose (\*units are comparable to United States Pharmacopeiea \[USP\])
Creon (Drug)
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.

Eligibility criteria

Inclusion Criteria: 1. Male and female subjects aged ≥12 years from the date of informed consent in the US and aged ≥18 years in the EU 2. Confirmed and documented diagnosis of CF 3. Diagnosed with severe EPI as defined by a fecal elastase ≤50 μg/g stool measured at Screening by a central laboratory. 4. Subject has controlled EPI and taking a stable dose of pancreatic enzyme replacement therapy (PERT) for 90 days prior to Screening. 5. Adequate nutritional status measured by body mass index (BMI) defined by: 1. BMI ≥25th percentile for children aged 12-17 years 2. BMI ≥18.5 kg/m2 for ≥18 years of age Exclusion Criteria: 1. History of fibrosing colonopathy or recurring distal intestinal obstructive syndrome within 6 months of Screening. 2. 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. 3. Known hypersensitivity or other severe reaction to any ingredient of the investigational product (IP), Creon, or the stool marker (FD\&C Blue #2). 4. 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.

Conditions

Exocrine Pancreatic Insufficiency (EPI) Cystic Fibrosis (CF)

Locations

Long Beach Memorial Medical Center — Long Beach, California, 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
The Cystic Fibrosis Institute — Glenview, Illinois, United States
University of Iowa — Iowa City, Iowa, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
University of Kentucky — Lexington, Kentucky, United States
MaineHealth Pediatric Specialty Care — Portland, Maine, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Boston Children's Hospita — Boston, Massachusetts, United States
University of Michigan, Michigan Medicine — Ann Arbor, Michigan, United States
Wayne State University Harper University Hospital — Detroit, Michigan, United States
University of Minnesota — Minneapolis, Minnesota, United States
Rutgers - Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
New York Medical College at Westchester Medical Center — Valhalla, New York, United States
Children's Hospital Medical Center of Akron — Akron, Ohio, 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
Toledo Children's Hospital — Toledo, Ohio, United States
Hershey Medical Center Pennsylvania State University — Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
University of Texas Southwestern / Children's Health — Dallas, Texas, United States
Adult Cystic Fibrosis Center at the University of Utah — Salt Lake City, Utah, United States
University of Wisconsin — Madison, Wisconsin, United States
Froedtert & Medical College of Wisconsin — Milwaukee, Wisconsin, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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