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Phase 2 Study to Assess the Safety and Efficacy of ANG003

RecruitingPhase 2

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

Who can join

Ages 12 and older · All sexes

Full 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.

About the 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.

What is being tested

Sponsor: Anagram Therapeutics, Inc. · Participants: 113 · Started: Apr 24, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07450547

Locations in the U.S.

CaliforniaLong Beach Memorial Medical Center, Long Beach
Center for Cystic Fibrosis at Keck Medical Center of USC, Los Angeles
ColoradoNational Jewish Health, Denver
FloridaUniversity of Florida, Gainesville (Not yet recruiting)
Central Florida Pulmonary Group, Orlando (Not yet recruiting)
IllinoisThe Cystic Fibrosis Institute, Glenview
IowaUniversity of Iowa, Iowa City (Not yet recruiting)
KansasUniversity of Kansas Medical Center, Kansas City
KentuckyUniversity of Kentucky, Lexington
MaineMaineHealth Pediatric Specialty Care, Portland (Not yet recruiting)
MassachusettsBoston Children's Hospita, Boston
Massachusetts General Hospital, Boston (Not yet recruiting)
MichiganUniversity of Michigan, Michigan Medicine, Ann Arbor
Wayne State University Harper University Hospital, Detroit
MinnesotaUniversity of Minnesota, Minneapolis
New JerseyRutgers - Robert Wood Johnson Medical School, New Brunswick
New YorkNew York Medical College at Westchester Medical Center, Valhalla (Not yet recruiting)
OhioChildren's Hospital Medical Center of Akron, Akron
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland (Not yet recruiting)
Nationwide Children's Hospital, Columbus, Columbus
Toledo Children's Hospital, Toledo
PennsylvaniaHershey Medical Center Pennsylvania State University, Hershey
University of Pittsburgh Medical Center, Pittsburgh (Not yet recruiting)
TexasUniversity of Texas Southwestern / Children's Health, Dallas
UtahAdult Cystic Fibrosis Center at the University of Utah, Salt Lake City
WisconsinUniversity of Wisconsin, Madison
Froedtert & Medical College of Wisconsin, Milwaukee (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.